Exhibit
10.8


 





 


TABLE
OF CONTENTS


 


	I.	PROJECT
    SUMMARY	2
	II.	BASIS
    OF SYSTEM CRITERIA	3
	1.0	General	3
	2.0	Site/Civil	4
	3.0	Concrete	5
	4.0	Masonry	6
	5.0	Structural
    / Steel	6
	6.0	Carpentry.	8
	7.0	Thermal
    and Moisture Protection	8
	8.0	Doors
    and Windows	9
	9.0	Finishes	11
	10.0	Specialties	13
	11.0	Equipment	15
	12.0	Furnishings	16
	13.0	Special
    Construction	17
	14.0	Conveying
    Systems	18
	15.0	Mechanical	19
	16.0	Electrical	56
	17.0	PROCESS	64
	III.	DESIGN/BUILD
    PROJECT DISCUSSION	81
	IV.	CLARIFICATIONS	88
	V.	ESTIMATE	99
	VI.	COMMERCIAL
    TERMS	99
	VII.	MILESTONE
    SCHEDULE	100
	VIII.	ATTACHMENTS	100


 


5110
Campus Drive ● Suite 110 Plymouth Meeting, PA 19462


Phone:
610.941.1001 ● Fax 610.941.0110 ● www. protecsinc.com


 




    	1



     


    

 





 


	I.	PROJECT
    SUMMARY


 


Hemoglobin
Oxygen Therapeutics, LLC (HbO2) has acquired the technology and IP to manufacture bovine derived Hemoglobin from a former company that
filed for bankruptcy. The Hemoglobin manufacturing and packaging processes were previously performed at three separate facility located
in Pennsylvania, Massachusetts and Canada. HbO2 is relocating the entire manufacturing, packaging and warehousing operations to its Pennsylvania
facility located at 674 Souder Road in Souderton, PA. The landlord has built a building expansion of approximately 34,000 SF that was
complete in July of 2017.


 


At
the request of HbO2, PROTECS has developed a scope of work and a Guaranteed Maximum Price ($GMP) for the design, construction and commissioning
of the planned fit-out of the building shell expansion. The fit-out will include the construction of new office space, laboratory space,
chemical storage, cGMP manufacturing and packaging, warehousing, locker rooms, bathrooms, supporting electrical/mechanical space and
the associated utilities. The intent of the project is for HbO2 to relocate the manufacturing, packaging and warehousing operations to
the Souderton facility. HbO2’s program is as follows:


 


	Description	 	Area (SF) 
	Office	 	 	10,800	SF
	Cleanroom ISO 8	 	 	12,100	SF
	Cleanroom ISO 7	 	 	600	SF
	Utility/Support Space	 	 	13,600	SF
	Warehouse	 	 	2,700	SF
	Laboratory	 	 	2,500	SF
	Equipment Platform	 	 	4,700	SF
	Total	 	 	47,000	SF



 


The
overall schedule for the project will require release of the $GMP within two days to enable subcontractor and material release for completion
in September 2018. A schedule outlining the overall project timeline including all stages of engineering, permit approval process, construction
activities, commissioning and validation for the project is also attached.


 


PROTECS
is prepared to assist HbO2 with moving forward on this project. Based on the preliminary information and the proposed design and construction
discussed, PROTECS recommends HbO2 continue with the methodology below to deliver this project. We believe proceeding in the fashion
outlined below will lead to the safest, most cost effective and timely delivery of this project


 


	 	●	Complete
    the project design and issue Bulletin #1 drawings and P&IDs.
	 	●	Confirm
    pricing and release specific subcontractors/vendors critical to the project schedule.
	 	●	Mobilize
    to site and commence construction activities.
	 	●	Construction
    management, scheduling, and cost control for all labor and materials managed at the site by PROTECS personnel.
	 	●	Commissioning
    and start-up.
	 	●	Occupancy
    permit will be obtained by PROTECS.
	 	●	Occupancy
    by HbO2.
	 	●	Validation
    facility and processes by HbO2.


 


A
summary description of the estimate basis follows:


 


www.protecsinc.com


 




    	2



     


    

 





 


	II.	BASIS
    OF SYSTEM CRITERIA


 


	 	1.0	General


 


The
intent of this project is to renovate the existing empty shell to provide for a mixed-use laboratory, office, manufacturing, packaging
and warehouse operations at the Souderton, PA facility. The current building is mixed use occupancy with use group F-2 Factory and use
group S-2 Low Hazard Storage – Non-Separated Mixed use. A detailed code review and hazardous material code review is included on
the drawings.


 


The
building will include the following occupancy classifications:


 


	 	●	F-2
    - Factory
	 	●	S-2
    – Low Hazard Storage
	 	●	B
    – Business Group


 


The
existing building is a steel and concrete structure.


 


The
design criteria employed on the project is defined below and will be in accordance with the requirements of the following codes and standards:


 


	 	●	International
    Building Code (IBC 2009)
	 	●	International
    Fire Code (IFC 2009)
	 	●	International
    Plumbing Code (IPC 2009)
	 	●	International
    Mechanical Code (IMC 2009)
	 	●	International
    Energy Conservation Code (IECC 2009)
	 	●	NFPA
    (Applicable) National Fire Protection Association
	 	●	NFPA
    70 National Electrical Code
	 	●	NFPA
    72 – National Fire Alarm Code (NFAC)
	 	●	NFPA
    70E – Standard for Electrical Safety Requirement for Employee Workplaces
	 	●	NFPA
    110 – Standard for Emergency and Standby Power Systems
	 	●	ADA
    Title II Accessibility Guidelines
	 	●	ASHRAE
    American Society of Heating Refrigeration and Air Conditioning Engineers
	 	●	SMACNA
    Sheet Metal and Air Conditioning Contractors National Association
	 	●	ASME
    American Society of Mechanical Engineers
	 	●	OSHA
	 	●	ASCE
    as noted below
	 	●	AISC
    as noted below


 


www.protecsinc.com


 




    	3



     


    

 


 


	 	●	ASTM
    as noted below
	 	●	ACI
    as noted below
	 	●	ANSI
    (Applicable) American National Standards Institute
	 	●	ASSE
    American Society of Sanitary Engineers
	 	●	AWWA
    American Water Works Association
	 	●	CAGI
    Compressed Air and Gas Institute
	 	●	CISPI
    Cast Iron Soil Pipe Institute
	 	●	CGA
    Compressed Gas Association
	 	●	Regulatory
    and validation requirements related to the facility design, construction and operations. Applicable sections of the following:






	 	○	FDA
    CFR Guidelines for GMP operations in the United States
	 	○	European
    Commission’s EU Guidelines to Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use, Annex 1


 


	 	2.0	Site/Civil


 


	 	2.1	Overview


 


There
will be no site improvements required for the project. The new building and all associated site/civil activities will be completed by
HbO2 as part of the building shell construction project.


 


The
site benchmark will be determined during detailed design as provided by the M&W Group.


 


The
project will have to conform the local zoning requirements which were completed by the M&W Group.


 


	 	2.2	Site
    Grading


 


Site
grading will be limited to the liquid nitrogen pad.


 


	 	2.3	Site
    Utilities – Electric, Natural Gas, Water, Sewer, Storm Drainage


 


The
natural gas service was upgraded by PECO and the service will serve the new and existing systems. The electrical service will be upgraded
to meet the project requirements. PPL will replace the existing pad mount transformer and set the new transformer on the existing vault.
A new termination cabinet, required by PPL, will be provided to feed the new and existing switchboards.


 


www.protecsinc.com


 




    	4



     


    

 


 


	 	2.6	Parking
    and Roadways


 


There
are no parking and/or roadway modifications required. The parking lot wearing course and line stripping will be completed by the landlord
after the completion of the project.


 


	 	2.7	Dock
    Area


 


The
new dock area and shipping / receiving will be completed by HbO2 as part of the building shell construction.


 


	 	2.8	Fencing


 


A
galvanized chain link fence with access gate and man gate will be provided at the bulk nitrogen tank pad.


 


	 	3.0	Concrete


 


The
concrete slab for the building expansion loading dock area is included as part of the building shell construction.


 


A
new concrete slab will be provided for the building expansion (except the loading dock area to be poured as part of the building shell
construction).


 


A
new concrete slab will be provided for the new second floor office area.


 


Reinforcement
of the concrete slab as required for the process equipment will be provided.


 


The
existing concrete floor will be cut and patched to accommodate new underground piping. The patchwork will include a vapor barrier and
reinforcing to “dowel-in” to the existing slab to remain. This work is based on the existing concrete slab floor being 6”
thick.


 


Interior
concrete housekeeping pads will be provided for the new electrical gear and mechanical equipment in Utilities #181 and #184. Inertia
bases will be provided directly onto the floor structure for pumps as required.


 


A
new exterior concrete pad will be provided for the liquid nitrogen tank.


 


Miscellaneous
concrete pads and curbs will be provided for architectural features such as the Serum Receiving wash-down area.


 


www.protecsinc.com


 




    	5



     


    

 


 


	 	3.1	Concrete


 


	 	a.	Footings
    (ACI 301): Normal weight mix, 4,000 psi compressive strength at 28 days
	 	b.	Slab
    on grade (ACI 360): 6 inches thick, normal weight mix, 4,000 psi compressive strength at 28 days
	 	c.	Housekeeping
    Pads: 6 inches thick, normal weight mix, 4,000 psi compressive strength at 28 days (existing slab to remain)


 


	 	4.0	Masonry


 


Masonry
work will be limited to new elevator hoistway walls and cutting/patching existing masonry for new openings. New openings will include
the following:


 


	 	●	Door
    openings from the existing building to the new expansion
	 	●	Mechanical
    penetrations from the existing building to the new expansion
	 	●	Door
    openings in the existing building


 


The
new elevator hoistway walls will be constructed of 8” CMU and will be grouted solid.


 


	 	5.0	Structural
    / Steel


 


The
renovation project will require structural steel dunnage for roof top equipment, structural reinforcement and framing for roof top equipment,
a second floor cat walk with metal grating for access to equipment requiring maintenance, two stair towers, SS platforms for process
tank access and a new second floor office area.


 


The
second floor office area will be 1 1⁄2” – 20 gauge composite metal deck with 2 1⁄2” normal weight concrete
slab (4” total thickness).


 


The
existing process equipment platforms relocated from the Cambridge, MA facility will not be re-used. New process equipment platforms with
stair / ladder access and diamond plate decking will be provided. The new platforms will be constructed of stainless steel with a #4
Mill finish for access to the process equipment. The platforms will be provided with the process skid assemblies and final assembled
during the skid installation.


 


Two
steel pan stair towers will be provided as required for egress / access to the second floor. Roof access from the stair towers will not
be provided. The stair tower construction will be open to the second floor level, but closed at the first floor for security. The construction
will not be rated for fire separation due to exceptions in the code.


 


www.protecsinc.com


 




    	6



     


    

 


 


Steel
framing will be provided for new roof top equipment at the same elevation as the existing roof framing.


 


Steel
dunnage will be provided to support the roof top chillers and generator equipment. The chiller dunnage will allow for 2’-0”
clear space between the finished roof and the bottom of steel to allow for access to equipment and roof drains. The dunnage will be bolted
connections with the steel being shop primed and painted. (See alternate price for all exposed structural steel dunnage to be hot- dipped
galvanized).


 


Supplemental
framing steel will be required as additional support around new penetrations exceeding one square foot. This angle framing will be shop
primed and installed with any field welds brushed and painted after installation. All other steel work will be performed using materials
in accordance with the following:


 


The
structural design will be in accordance with the requirements of the following codes and standards:


 


	 	5.1	Gravity
    Live Loads (Code Minimum)


 


	 	a.	Slab
    on grade:	200
    pounds per square foot
	 	b.	Second
    floor:	65
    (50 office + 15 for partitions) pounds per square foot
	 	c.	Second
    floor cat walk (Main):	40
    pounds per square foot
	 	d.	Second
    floor cat walk (Egress):	60
    pounds per square foot
	 	e.	Roof
    level:	20
    pounds per square foot plus the actual weight of mechanical equipment


 


	 	5.2	Wind
    Loads (Code Minimum)


 


	 	a.	Basic
    wind velocity (per ASCE 7-05) = 90 mph
	 	b.	Exposure
    category = C
	 	c.	Wind
    importance factor = 1.0


 


	 	5.3	Seismic
    Loads (Code Minimum)


 


	 	a.	Spectral
    response acceleration at short period, Ss = 0.276g
	 	b.	Spectral
    response acceleration at 1 second period, S1 = 0.062g
	 	c.	Seismic
    Occupancy Category = II
	 	d.	Site
    class = C
	 	e.	Seismic
    Design Category = B


 


www.protecsinc.com


 




    	7



     


    

 


 


	 	5.4	Structural
    Steel


 


	 	a.	Wide
    flange members: ASTM A992
	 	b.	Angle,
    channel, plates, and rods: ASTM A36
	 	c.	Hollow
    structural shapes: ASTM A500, Grade B
	 	d.	Structural
    pipe: ASTM A53, Type E, Grade B
	 	e.	Structural
    bolts: ASTM A325-N


 


	 	5.5	Metal
    Deck


 


	 	a.	1-1/2”
    deep x 20 gauge composite metal floor deck (galvanized)
	 	b.	1-1/2”
    deep x 22 gauge wide rib metal roof deck (galvanized)


 


	 	6.0	Carpentry


 


	 	6.1	Blocking


 


Wood
grounds and nailers will be provided for equipment and roof supports as required. Wood in contact with masonry and roof nailers will
be treated in accordance with AWPA C2 requirements, and will be mechanically fastened securely to substrate. The use of exposed wood
will be prohibited in any interior areas. Wood used for blocking will be fire retardant treated.


 


	 	6.2	Millwork


 


Millwork
will primarily consist of plastic laminate over pressboard in the restroom areas. A solid surface countertop will be provided in the
CNC restrooms. Painted wood trim will be provided at the top of the wall surrounding Stair 1. Plastic laminate window sills will be provided
at most of the exterior windows in the addition.


 


	 	7.0	Thermal
    and Moisture Protection


 


	 	7.1	Roofing


 


All
roof materials will be designed as an assembly in order to maintain a single source roof warranty. All roof flashing is per SMACNA’s
standard flashing details, including the proposed building expansion joints.


 


Roof
work related to the fit out project will be limited to new penetrations and equipment curbs in the existing roof. For existing roof area
requiring cutting and patching, roof flashing, cutting, and patching will be provided to conform to the existing manufacturer’s
warranty requirements per the manufacturer’s standard details. This will be provided to maintain the existing warranty and bond,
if any on the existing roof.


 


www.protecsinc.com


 




    	8



     


    

 


 


	 	7.2	Sealants


 


All
joints will be sealed with an appropriate sealant and backer as required. At the building interior, all products will be FDA approved
and bacteria inhibiting. Interior building joints and penetrations in fire rated wall construction to be fire stopped with an appropriate
UL assembly. Exterior masonry wall assemblies will receive approved block filler as required for moisture protection.


 


All
exterior joints will be sealed watertight.


 


	 	7.3	Fireproofing


 


Fireproofing
is not required.


 


	 	7.4	Firestopping


 


Fire
caulking as manufactured by Hilti or other similar manufacturers will be the primary material used for this. Where there are multiple
penetrations an assembly will be prepared in consultation with the architect and engineer.


 


	 	8.0	Doors
    and Windows


 


	 	8.1	Hollow
    Metal Doors


 


Doors
will be constructed of hollow metal with vision lights where indicated and be mounted in hollow metal frames. The hollow metal frames
will be knock down wrap around type in all non-process areas. Exterior egress doors are existing. Where doors are installed in rated
walls, UL fire rated doors, frames and hardware will be installed. Doors will have a painted finish over a factory prime coat.


 


Hollow
metal frames will be 18 gauge for interior and 14 gauge for exterior. Interior frames will be cold rolled steel and exterior frames will
be galvanized steel. Hollow metal doors will be 20 gauge for interior and 16 gauge for exterior, primed gray. Interior doors will be
cold rolled steel and honeycomb core and exterior doors will be galvanized steel with polyurethane (insulated) core.


 


All
doors will be a standard 7’-0” height unless otherwise noted.


 


	 	8.2	Wood
    Doors


 


Doors
in the office areas will be wood doors and will be mounted in hollow metal frames. The frames will be knock down wrap around type. Hollow
metal frames will be 16 gauge. Interior frames will be cold rolled steel and exterior frames will be galvanized steel.


 


Doors
will be a pre-finished stain grade. Wood doors will be Mohawk Commercial Series finished to one of Mohawk’s standard colors or
approved equal.


 


www.protecsinc.com


 




    	9



     


    

 


 


	 	8.3	Hardware


 


General
door hardware will be ADA compliant. Locksets will be cylindrical type, heavy duty. Electrified hardware will be installed where security
devices are shown. Double doors will include flush bolts on the inactive leaf. A typical door will receive 1 1⁄2 pair hinges.


 


Fire
rated doors will be equipped with surface mounted overhead closers. All doors other than office doors and cleanroom doors will be equipped
with surface mounted overhead closers. Cleanroom doors will be equipped with concealed closers.


 


Door
hardware will be Hager hinges or approved equal; Schlage “ND” series locks or approved equal; Falcon DL-24/25 series panic
hardware or approved equal; Schlage M450 series magnetic locks or approved equal; Von Duprin 6000 series electric strikes or approved
equal; LCN 4010/4110/4020 series closers or approved equal; Hager manual flush-bolts, floor and wall stops, armor plates and weather-
stripping products or approved equals; Von Duprin power supplies or approved equal. Hardware are US26D, US32D and 689 finishes. Construction
keying for doors will be provided. Final keying will be completed by HbO2.


 


	 	8.4	Vision
    Panels


 


Rated
fire glass will be provided in all interior doors that carry a rating label and are programmed as requiring vision panels. Tempered safety
glass will be provided in other glazing applications in hollow metal frames. Exterior hollow metal doors are existing.


 


Door
lites will typically be 1⁄4” thick clear tempered safety glass and 24”x32” in size, 5”x 30” (100 si)
for rated lites. Door lites within the cleanroom suites will be finished flush with the door. The glass will be caulked in place and
gasketed. The frames for these windows will be hollow metal, welded. Where both sides of the window are clean, the glass will be flush
on both sides. Where only one side is clean, the non-cleanroom side will not be flush glass.


 


	 	8.5	Special
    Doors


 


Where
special modular cleanroom partitions are used the doors will be integral to the system. Door will be constructed of powder coated aluminum
with vision lights where indicated and will be mounted in aluminum frames.


 


	 	8.6	Storefront


 


There
are no storefront systems required.


 


www.protecsinc.com


 




    	10



     


    

 


 


	 	8.7	High
    Speed Roll Up Doors


 


Fabric
type high speed roll up doors (HSRUD) with wall based activation switches or overhead pull strings and vision panels will be provided
as indicated on the plans. The HSRUDs will ensure a tight seal to maintain space pressurization in the cleanroom areas.


 


Note:
Refer to contract drawings for door type and locations.


 


	 	9.0	Finishes


 


	 	9.1	Partitions


 


Gypsum
wall board (GWB) partitions will be constructed of cold-formed metal studs of appropriate size and gauge for interior furred-out and
utility chase walls and will be finished in standard gypsum board. In wet locations moisture resistant type gypsum board will be used.
Deep-leg deflection tracks will be provided at the tops of light gauge steel partitions that are built to the underside of the deck above
to alleviate crushing and deformation. The layers of GWB and thickness will be governed by the rating of the partition as applicable.


 


All
finished gypsum wallboard within the laboratories, corridors, warehouse and office areas will have a level 4 finish.


 


Ceramic
tile walls up to four feet will be provided within the new bathrooms.


 


A
prefabricated cleanroom wall system as manufactured by Dagard will be used for interior walls within the cleanroom area. The cleanroom
wall panels and accessories have been purchased by HbO2 and will be integrated into the project design. The full thickness walls will
be typically 4-3/4”, nominally, consisting of 151/256” (15mm) liner panels fastened directly over metal studs or hat track
channel of the appropriate size and gauge. The wall finish will be a PVC coating with solvent welded seams. The walls will have integral
coved corners. This same wall system will be used to construct a “dust alcove” in the Weigh Room in in lieu of installing
a piece of equipment.


 


Note:
Refer to contract drawings identifying wall partition type for each room.


 


	 	9.2	Ceilings


 


The
ceiling systems will include GWB ceilings, suspended grid systems, prefabricated cleanroom ceiling systems and open structure areas.


 


The
GWB ceiling will include GWB panels screwed to suspended GWB grid system.


 


www.protecsinc.com


 




    	11



     


    

 


 


The
office area ceiling tiles will sit in a 2’ by 4’ inverted tee ceiling grid system suspended by wire from the overhead structure.
The office area tiles will be a second look type tile.


 


The
lab area ceiling tiles will sit in a 2’ by 4’ inverted tee ceiling grid system suspended by wire from the overhead structure.
The ceiling tiles will be mylar or vinyl coated composite tiles.


 


The
cleanroom ceilings will be 2’ x 4’ modular suspended ceiling system as manufactured by Dagard. The walls will have integral
coved corners. The ceiling will NOT be walkable and access to equipment above the cleanrooms will be from a calk walk system.


 


Note:
Refer to contract drawings identifying ceiling type for each room.


 


	 	9.3	Finishes


 


	 	9.3.1	Floor
    Coatings / Coverings


 


The
epoxy flooring will be a troweled on epoxy coating similar to that provided by Stonhard, Cornerstone, Sherwin Williams or approved equal.
The epoxy flooring system will be similar to the Stonclad GS system with a Stonkote GS4 topcoat or approved equal. This coating will
be 3/16” thick with a slip resistant finish. The epoxy flooring system should be resistant to the chemicals indicated by HbO2.


 


The
coving will match the epoxy floor and will be a hospital type integral cove to 4” up the wall.


 


The
vinyl composite tile will be 12” x 12” x 1/8” thick with a vinyl cove base. The VCT will be similar to Armstrong Standard
Excelon or approved equal.


 


The
polished concrete floors will be a pigmented finish or clear finish depending on the location.


 


Wood
look luxury vinyl flooring system similar to the Venue Wood product by Tandus Centiva will be provided in the office area.


 


Ceramic
tile floors will be provided within the bathrooms (not including production area bathrooms). 12”x24” Dal Tile San Michele
glazed paver tile or approved equal with 3”x12” bullnose cap will be provided.


 


Note:
Refer to contract drawings identifying flooring type for each room.


 


www.protecsinc.com


 




    	12



     


    

 


 


	 	9.3.2	Wall
    and GWB Ceiling Coatings / Coverings


 


The
epoxy paint will be a water-borne epoxy paint. On new walls, two coats will be provided over a primer coat. On existing walls one coat
will be provided over the existing coat. On block walls a coating of block filler will be provided before painting.


 


The
latex paint will be a water based paint. On new walls, two coats will be provided over a primer coat. On existing walls one coat will
be provided over the existing coat. On block walls a coating of block filler will be provided before painting.


 


Accent
walls will be provided in the following areas:


 


	 	●	Office
    Area


 


	 	●	Entrance
    / Lobby Area


 


Note:
Refer to contract drawings identifying wall finish for each room.


 


	 	9.3.3	Special
    Coatings


 


There
are no special coatings.


 


	 	10.0	Specialties


 


	 	10.1	Fire
    Extinguisher Accessories


 


HbO2
will furnish 10 lb portable dry chemical type fire extinguishers for mounting in cabinets or on hooks provided under this scope of work.


 


Fully
or Semi-recessed painted steel fire extinguisher cabinets with vertical duo panel doors will be provided to house HbO2 supplied ten-pound
multi-purpose dry chemical portable fire extinguishers at intervals to satisfy building code requirements.


 


	 	10.2	Toilet
    Partitions / Accessories


 


The
toilet rooms will be provided with accessories including grab bars, mirrors, dispensers for toilet tissue, soap, paper towels, and feminine
products, and waste disposal units. This includes floor mounted, powder coated metal toilet partitions in the office area and ceiling
hung, powder coated metal toilet partitions in the production area. Urinal screens are provided. The appropriate ADA compliant accessories
are included within these items.


 


	 	10.3	Laboratory
    Casework


 


Refer
to Division 12.


 


www.protecsinc.com


 




    	13



     


    

 


 


	 	10.4	Screens


 


Specialty
screens are not required.


 


	 	10.5	Warehouse
    Racks


 


The
warehouse racking system will be furnished and installed by HbO2. The contract drawings will indicate locations for reference and coordination
only.


 


The
warehouse has been designed to accommodate 28 pallet positions (maximum 2400lbs per pallet position on floor level, maximum 1500lbs per
pallet on the 2nd level, maximum 500lbs on the top level) per level with an initial height of 3-tiers (54” clear between
tiers). The current concrete slab is assumed to be 6”. Any increase in height above the three tiers will require evaluation of
the existing slab and warehouse racking system.


 


The
QA/Quarantine has been designed to accommodate 12 pallet positions (maximum 2500lbs per pallet position on floor level, maximum 2500lbs
per pallet on the 2nd level) with an initial height of 2-tiers (54” clear between tiers). The concrete slab for this area of the
fit out will be designed for the loads indicated above. Any increase in height above the two tiers will require evaluation of the slab
design and warehouse racking system.


 


	 	10.6	Wall
    Bumper / Corner Guards


 


4”x
4” x 96” SS Corner Guards will be provided.


 


A
wall mounted wall protection system (cart protection) has been provided as an alternate.


 


Note:
Refer to contract drawings identifying corner guard and wall bumper locations.


 


	 	10.7	Interior
    Room Signage


 


Interior
room signage except required by code will be completed by HbO2.


 


	 	10.8	Gowning
    Room Accessories


 


Gowning
room accessories (i.e. mirrors, hooks, dispensers, etc...) will be furnished and installed by HbO2. The gowning room accessories
layout will be included on the project drawings and indicated as “by owner”. Blocking for wall mounted items will be based
on the locations indicated.


 


www.protecsinc.com


 




    	14



     


    

 


 


	 	10.9	Fork
    Truck


 


A
Raymond 31 Easi Reach forklift will be provided by HbO2. Power for the lift battery charger will be provided in the location indicated
on the drawings.


 


	 	10.10	Lockers
    / Benches


 


Lockers
will be provided within locker rooms. Lockers will be double tier and approximately 12”W x 18”D x 72”H. Lockers will
be provided with sloped tops with a “Z” base. Key and/or combination pad locks will be by HbO2. The lockers will be numbered
sequentially starting at #1.


 


Benches
will be provided within locker rooms and personnel airlocks as indicated on the drawings. Benches will be anchored into the floor with
SS anchors to allow for benches to be removable.


 


	 	10.11	Bug
    Light


 


Bug
lights will be indicated on the project drawings and will furnished and installed by HbO2. Power for the bug lights will be provided
at the following locations:


 


	 	●	Entrance
    Vestibule
	 	●	Loading
    Dock
	 	●	Serum
    Receiving
	 	●	Exterior
    Doors In Utilities Corridor


 


	 	11.0	Equipment


 


	 	11.1	Fume
    Hoods


 


See
Division 12 for details.


 


	 	11.2	Loading
    Dock Equipment


 


Loading
dock equipment is existing.


 


	 	11.3	Process
    Equipment


 


See
division 17.0 for details.


 


	 	11.4	Lab
    Equipment


 


Lab
equipment, refrigerators, freezers, bench top autoclaves and incubators will be by HbO2.


 


	 	11.5	Overhead
    Projector


 


The
overhead projectors will be furnished by HbO2. Installation and electrical hook up will be provided.


 


www.protecsinc.com


 




    	15



     


    

 


 


	 	11.6	Wash
    Down Equipment


 


The
wash down equipment for the Serum receiving will be relocated from its location in the warehouse.


 


	 	11.7	Labeling
    Equipment


 


The
labeling equipment (labeling machine, label counter, and overwrap machine) will be furnished and installed by HbO2.


 


	 	11.8	Lab
    Glass Washer


 


A
lab glass washer will be provided in the lab area and will be served by the lab RODI water system. The glass washer will be qualified,
but not validated and a GMP washer is not required.


 


	 	11.9	Fork
    Truck


 


A
Raymond 31 Easi Reach forklift will be provided by HbO2. Power for the lift battery charger will be provided in the location indicated
on the drawings.


 


	 	12.0	Furnishings


 


	 	12.1	Laboratory
    Casework


 


Used
laboratory metal casework and new epoxy countertops will be provided in the laboratories and final packaging. The used casework will
have the exterior electrostatically painted in place after installation. The casework layout will be determined based on cabinet availability
and will be reviewed with HbO2 prior to installation.


 


The
casework will be 30” deep (including service chase) and 36” high. A peg board will be provided in the Glass Wash room.


 


	 	12.2	Fume
    Hoods


 


A
4’ Benchtop fume hood with an epoxy work surface and appropriate metal base cabinets will be provided in the weigh room.


 


ASHRAE
110 testing of fume hoods is not included.


 


www.protecsinc.com


 




    	16



     


    

 


 


	 	12.3	Bio-Safety
    Cabinets


 


A
Bio-Safety cabinet (recirculating type) will be furnished and installed by HbO2 in the new Micro Lab.


 


	 	12.4	Dispensing
    Hood


 


See
section 9.0


 


	 	12.5	Pass-Thru’s


 


A
24”W x 24”H x 24” L ID material pass through, constructed with 16 gauge 304 SS, with surface mounted SS frame doors
with 1⁄4” tempered glass window, continuous hinges, 1⁄4 turn chrome plated handles, and a mechanical interlock will be
provided between the Following:


 


	 	●	Filling
    room and Labeling and Overwrap room.
	 	●	Filling
    room and Aseptic Waste Out room.
	 	●	Filling
    room and Aseptic Equipment Prep room.


 


	 	12.6	Office
    Furnishings


 


Office
furnishings, including but not limited to the reception desk, computers, copiers, IT equipment, cubicles, desks and chairs, shredders,
book cases and conference tables, will be provided and installed by HbO2.


 


	 	12.7	Process
    Area / Warehouse Furnishings


 


Process
area furnishings, including but not limited to desks/chairs, rolling tool boxes, shelving, SS work tables, computers/printers, storage
racks, rolling racks, rolling tables, rolling cages, file cabinets (Fire King), metro racks, scales, check weight stations, integrity
tester, peg boards and flammable storage cabinets, will be provided and installed by HbO2.


 


	 	12.8	Gas
    Cylinders and Storage Cages / Racks


 


Gas
cylinders and storage cages / racks will be provided and installed by HbO2.


 


	 	12.9	Window
    Treatments


 


Except
for the electrical room where privacy film will be applied to the existing windows, window treatments will be provided and installed
by HbO2.


 


	 	12.10	Office
    Furniture


 


Office
furniture including workstations/cubicles will be provided and installed by HbO2. PROTECS will provide power to the cubicles for final
connection by HbO2. Locations for power connections will be shown on the contract drawings based on a generic furniture layout unless
HbO2 provides specific furniture selections and power connection requirements. Power connections will be configured as whips unless HbO2
provides specific furniture selections.


 


	 	13.0	Special
    Construction


 


	 	13.1	Leak
    Detection


 


Low
level oxygen sensors will be provided by HbO2 if required.


 


	 	13.2	Rigging


 


Rigging
will be required for new steel and mechanical/electrical equipment.


 


	 	13.3	Rigging
    (Owner Process Equipment)


 


See
division 17 for details.


 


	 	13.4	Cold
    Storage Room (Relocated)


 


The
existing cold room will be relocated to its new location.


 


	 	13.5	Cold
    Storage Room (New)


 


A
new cold storage room will be provided per the below criteria:


 


	 	(a)	Performance:
	 	 	 





	 	(i)	Temperature
    Performance
	 	 	 





	 	1.	Design
    Temperature Setpoint: +5 degrees C +/-3C
	 	2.	Maximum
    temperature uniformity between any two points: +/- 2 degree C horizontal and +/- 3 degrees C vertical.
	 	3.	Design
    Humidity Setpoint: No humidity control.
	 	4.	System
    Capacity: Refrigeration system shall be capable of maintaining specifications under the following conditions:
	 	 	 





	 	a.	Temperature
    Range Surrounding Room: 18 to 28 degrees C.
	 	b.	Ambient
    Temperature at Air-Cooled Condensing Units: 120 degrees F.
	 	c.	Man
    Door Openings: Six (6) per hour for an average duration of 15 seconds.
	 	d.	Personnel:
    Two (2) person per hour for an average duration of 10 minutes.
	 	e.	Environmental
    Room Load: Lighting.
	 	f.	Materials:
    One ambient temperature pallet of material (200lbs) will be loaded into the cold room per day.


 


www.protecsinc.com


 




    	17



     


    

 


 


	 	(ii)	Noise:
    Room shall generate no more than 70 dBA at any point across room at 6 feet above floor.


 


	 	1.	All
    mechanical and electrical equipment shall generate no more than 75 dBA within 3 feet of unit in any direction.
	 	 	 





	 	(iii)	Structural:
	 	 	 





	 	1.	Dead
    Loads: Self-weight of all elements and attached finishes.
	 	2.	Seismic
    Loads: Per applicable codes
	 	 	 





	 	a.	General:
    Connections shall be positive anchorage without consideration for frictional resistance.


 


	 	(b)	Backup
    System: Provide Cold Storage Room with a 100 percent redundant refrigeration system (including condensers, compressors, and evaporator
    coils) and blower system, with these systems having automatic switchover during normal operation.
	 	(c)	Lighting:
    Lighting output shall be a minimum of 50 foot-candles at a measured 40 inches above floor based on empty space.
	 	(d)	Room
    Size (interior dimensions): 8’-0” wide x 12’-6” long x 8’-0” high.
	 	(e)	Doors:
    1 man door (4’-0” x 7’-0”)
	 	(f)	Floor:
    Cold Box will sit on the existing concrete slab.
	 	(g)	Electrical
    Requirements:


 


	 	(i)	Control
    Panels: 120/208 V, 3 phase, 60 Hz, 3 wire.
	 	 	 





	 	1.	Provide
    unit-mounted transformer at control panel for all internal connections.
	 	 	 





	 	(ii)	Condensing/Compressor
    Units: 460 V, 3 phase, 60 Hz 
	 	(iii)	Lights: Single point connection to control panel power supply.
	 	(iv)	Electrical Receptacles: 120
    V, 20 amp GFCI.
	 	 	 





	 	(h)	Condensing
    Equipment: To be located on top of the cold room


 


	 	14.0	Conveying
    Systems


 


	 	14.1	Elevator


 


A
two-stop hydraulic machine-room-less (MRL) elevator with a 5000lbs capacity will be provided. The basis of design is the Otis HydroFit,
and the shaft and pit requirements will be based on this unit. The elevator pit is not included as part of the building shell construction.
The pit will be included in the fit out project to allow coordination with and confirmation of the manufacturer’s requirements.


 


www.protecsinc.com


 




    	18



     


    

 


 


	 	15.0	Mechanical


 


	 	15.1	Introduction


 


The
project will require new HVAC systems to support the fit out. The intent of this work is to duplicate/supplement the existing systems
approach by adding specific new items of equipment.


 


Accordingly,
the new HVAC equipment that will be added is summarized below (Refer to equipment list for sizing):


 


	 	●	Plant
    steam boiler
	 	●	Roof
    / Wall mounted exhaust fans
	 	●	Roof
    top air-handling units
	 	●	Humidifiers
	 	●	CRAC
    Units
	 	●	VAVs
    / FTUs
	 	●	Electric
    Duct Heaters
	 	●	HEPA
    Filters
	 	●	Unit
    Heaters
	 	●	Louvers


 


The
work associated with these components will include the procurement, receipt, rigging, installation, piping or duct connection to the
existing main, electrical connection, installation of new control devices, start-up, testing, commissioning, and turn-over.


 


The
equipment will be provided with direct drives where possible and variable frequency (VFD’s) drives or ECM variable speed motors
where required.


 


A
mechanical “cat walk” will be provided above the production cleanroom to provide access to equipment requiring service and
access to controlling valves, dampers, etc...


 


The
balance of this section describes the approach for the project’s mechanical systems.


 


www.protecsinc.com


 




    	19



     


    

 


 


	 	15.2	Outside
    Design Conditions


 


The
summer outdoor design conditions used will be the ASHRAE 0.4% dry bulb temperature and mean coincident wet bulb for Souderton, PA. The
ASHRAE 0.4% numbers are exceeded for approximately 35 hours each summer in a typical year. The winter design conditions will be the ASHRAE
99.6% dry bulb temperature and outdoor design conditions will be as follows:


 


	Area	 	Outdoor
    Design Conditions
	 	 	Summer	 	Winter
	Cleanrooms	 	93°F
    db/75°F wb	 	13.8°F/4.3
                                                         grains

	Laboratories	 	93°F
    db/75°F wb	 	13.8°F/4.3
                                                         grains

	Warehouse	 	93°F
    db/75°F wb	 	13.8°F/4.3
                                                         grains

	Office	 	93°F
    db/75°F wb	 	13.8°F/4.3
                                                         grains

	Mechanical
    and other Ventilated spaces	 	93°F
    db/75°F wb	 	13.8°F/4.3
                                                         grains



 


The
elevation of the site is 600 ft.


 


www.protecsinc.com


 






    	20



     


    

 


 





	 	15.3	Interior
    Design Conditions


 


The
design temperatures for the interior zones are outlined below (these are design ranges, validation ranges, if applicable, shall be broader):


 


	AHU
    Number	 	AHU
    Zone Name	 	Temperature	 	Relative
    Humidity
	

    AHU-06
	 	Filling
                                            Area - Rooms: 168, 168A, 168B,

    168C)
	 	 

    65°F
    +/- 3°F
	 	 

    30%
    - 70% RH

	

    AHU-04
    & AHU-05
	 	Process
                                            Area – Rooms: 157, 164, 165, 167,

    169,
    169A, 170, 171,

    174
	 	 

    68°F
    +/- 3°F
	 	 

    30%
    - 70% RH

	AHU-04
    & AHU-05	 	Process
    Area – Rooms: 172, 173, 173A, 175	 	68°F
    +/- 3°F	 	30%
    - 70% RH
	AHU-04
    & AHU-05	 	Process
                                            Area – Rooms: 149, 156, 162A, 163A,

    176,
    176A, 180
	 	 

    68°F
    +/- 3°F
	 	 

    30%
    - 70% RH

	AHU-08	 	Office
                                            Area – Rooms:

    160,
    160B, 161, 161D,

    162,
    163, 177, 179,

    179,
    200, 201, 202,

    203,
    204, 205, 206,

    207,
    208, 209, 210,

    211,
    212, 213, 214,

    215,
    220
	 	Heating:
                                            70°F

    +/-
    5°F Cooling: 75°F +/- 5°F
	 	Summer:
    <65% Winter: Uncontrolled
	AHU-08	 	Support
    & Utility Space – Rooms 161A, 161C, 181, 182	 	Heating:
                                            70°F

    +/-
    5°F Cooling:

    75°F
    +/- 5°F
	 	Summer:
    <65% Winter: Uncontrolled
	AHU-08	 	Metrology
    Lab – Room 161B	 	Heating:
                                            70°F

    +/-
    5°F Cooling:

    75°F
    +/- 5°F
	 	Summer:
    <65% Winter: Uncontrolled
	AHU-08	 	Chemical
    Storage – Room 183	 	70°F
    +/- 5°F	 	Summer:
    <65% Winter: Uncontrolled
	AHU-09
                                            and Existing AHU-02
	 	Warehouse
                                            – Rooms 139, 148, 150, 151,

    153
	 	75
                                            Heating: 70°F +/- 5°F Cooling:

    75°F
    +/- 5°F
	 	Uncontrolled
	AHU-09	 	Final
    Packaging Room 155	 	68°F
    +/- 3°F	 	30%
    - 70% RH
	AHU-09	 	Laboratories
                                            – Rooms 105A, 105, 118, 121,

    123
	 	70°F
    +/- 3°F	 	30%
    - 70% RH
	SF-4.1
    & SF-4.2	 	Utilities
    – Room 184	 	Summer:

    <100F

    Winter:
    >60F
	 	Uncontrolled
	AHU-07	 	Micro
                                            Lab – Room

    119
	 	70°F
    +/- 3°F	 	30%
    - 70% RH


 


www.protecsinc.com


 




    	21



     


    

 


 


NOTE:
AHU tags noted above and below reflect the total unit count for the building including existing and are all noted here as AHUs. The drawings
depict the new units as Roof Top Units (RTUs). See the below table for summary:


 


	Unit
    Tag	 	Area
    Served
	AHU-1	 	Existing
    Process Area Unit
	AHU-2	 	Existing
    Lab Area Interior Unit
	AHU-3	 	Existing
    Office Area Exterior Unit
	AHU-4
    (RTU-1)	 	New
    Process Area Unit
	AHU-5
    (RTU-2)	 	New
    Process Area Unit 
	AHU-6
    (RTU-3)	 	New
    Fill Suite Unit 
	AHU-7
    (RTU-4)	 	New
    Micro Lab Unit
	AHU-8
    (RTU-5)	 	New
    Office and Support Area Unit
	AHU-9
    (RTU-6)	 	New
    Renovation Area Unit


 


NOTE:
The relative humidity set points will be: Winter – 40% RH, Summer – 60% RH.


 


Humidity
control for process and fill areas will be provided by a gas fired humidification boilers. Humidity control for the QC Labs will be provided
by electro-steam humidifiers with their own dispersion manifold located in supply ductwork to support the zones indicated. The humidifiers
will be controlled with wall mounted humidity sensors and will connected to the building BAS.


 


Dehumidification
will be accomplished through the AHUs.


 


For
both humidification and dehumidification Fill Room #168 was selected as the controlling sensor location for AHU-06. The other rooms are
generally expected to be in the range; however, conditions may vary as they will be following the lead of the system to satisfy the critical
room, Fill Room #168. Each functional room or group of rooms will have its own temperature control zone.


 


For
both humidification and dehumidification GMP Production #168 was selected as the controlling sensor location for AHU-04 and AHU-05. The
other rooms are generally expected to be in the range; however, conditions may vary as they will be following the lead of the system
to satisfy the critical room, GMP Production Room #170. Each functional room or group of rooms will have its own temperature control
zone. Additional process related room humidifiers will be provided as noted above for rooms with winter humidification control.


 


Temperature
control for the building will be provided by electric duct heaters to support the zones indicated.


 


www.protecsinc.com


 




    	22



     


    

 


  


Note:
Refer to contract drawings identifying temperature and humidity zones and selected controlling sensor locations.


 


Room
Classifications / Design Air Change Rates


 


The
design air change rates for the classified interior zones are outlined below (these are design ranges, validation ranges, if applicable,
shall be broader):


 


	Room	 	ISO
    / EU Classification	 	Particulate
    Count/Size	 	Design
    Air Change Rate or FPM
	Filling
                                            Area - Rooms: 168, 168A, 168B,

    168C)
	 	ISO
    7 / Grade B	 	352,000
                                            >

    0.5micron,
    83,200 >

    1
    micron, 2,930 > 5 micron
	 	50
    ACH
	Process
                                            Area Zone – Rooms: 157, 164, 165,

    167,
    169, 169A,

    170,
    171, 174,

    172,
    173, 173A,

    175
	 	ISO
    8 / Grade C	 	 

    3,520,000
    > 0.5

    micron,
    832,000/ >1

    micron,
    29,300 >5 micron
	 	20
    ACH
	Process
                                            Area – Rooms: 149,

    156,
    162A,

    163A,
    176,

    176A,
    180
	 	

    CNC
    / Grade D
	 	 

                                                         3,520,000
                                            > 0.5

    micron,
    832,000/ >1

    micron,
    29,300 >5 micron
	 	20
    ACH
	Office
                                            Area – Rooms: 160,

    160B,
    161,

    161D,
    162, 163,

    177,
    179, 179,

    200,
    201, 202,

    203,
    204, 205,

    206,
    207, 208,

    209,
    210, 211,

    212,
    213, 214,

    215,
    220
	 	N/A	 	N/A	 	N/A
	Support
                                            & Utility Space –

    Rooms
    161A, 161C, 181, 182
	 	N/A	 	N/A	 	N/A
	Metrology
                                            Lab –

    Room
    161B
	 	N/A	 	N/A	 	12
    ACH
	Chemical
    Storage – Room 183	 	 

    N/A
	 	 

    N/A
	 	 

    N/A

	Warehouse
                                            – Rooms 139, 148,

    150,
    151, 153
	 	 

    N/A
	 	 

    N/A
	 	 

    N/A

	Final
                                            Packaging

    -
    Room 155
	 	N/A	 	N/A	 	12
    ACH
	Laboratories
                                            – Rooms 105A, 105, 118, 121,

    123
	 	 

    N/A
	 	 

    N/A
	 	 

    12
    ACH

	Utilities
                                            – Room

    184
	 	N/A	 	N/A	 	N/A
	 

    Micro
    Lab – Room 119
	 	 

    ISO
    7
	 	352,000
                                            > 0.5micron, 83,200 > 1 micron, 2,930 > 5 micron
	 	 

    50
    ACH



 


	 	15.4	Ventilation
    Air


 


Ventilation
air will be as required by the 2009 International Mechanical Code and ASHRAE 62-2001 or as required for pressurization and makeup air.
Unless noted in the tables above, the supply air rates will be based on heating load and/or exhaust air requirements, whichever is greater.
Outdoor air supply rates will be based on minimum dilution ventilation requirements for occupant comfort, occupant density, pressurization
criteria, contamination control, and/or exhaust air requirements.


 


	 	15.5	Internal
    Load Criteria


 


Internal
heat gains from lighting, people and electric-powered or other heat generating equipment were evaluated using the following criteria.


 


Occupancy
loads are based on one person within Column Cleaning (Room #175), one person within Equipment Staging/COP (Room #173A), one person within
Commodity/Equipment Prep (Room #172), two people within Materials Exchange Clean Side (Room #169), two people within Weigh Room (Room
#171), six people within GMP Production Room (Room #170), Fill Room (Room #168), four people within Labeling & Overwrap (Room #167)
and one person within an office/cubicle.


 


www.protecsinc.com


 




    	23



     


    

 


 


	Item
    / Category	 	Sensible
                                            Heat

                                                                                Gain
	 	Latent
                                            Heat

                                                                                Gain

	People:	 	 	 	 
	 	 	 	 	 
	Cleanrooms	 	275	 	475
	Laboratories	 	275	 	275
	Warehouse	 	275	 	275
	Office	 	275	 	275
	Mechanical
    & Utility Spaces	 	275	 	275
	 	 	 	 	 
	Lighting:
	 	 	 	 	Heat
                                            Gain

                                                         Watts/Sq.
                                            Ft.

	Cleanrooms	 	 	 	1.0
	Laboratories	 	 	 	1.0
	Warehouse	 	 	 	1.0
	Office	 	 	 	1.0
	Mechanical
    & Utility Spaces	 	 	 	1.0
	 	 	 	 	 
	Equipment:
	 	 	 	 	Heat
                                            Gain 

                                                         Watts/Sq.
                                            Ft.

	Cleanrooms	 	 	 	5.0
	Laboratories	 	 	 	5.0
	Warehouse	 	 	 	5.0
	Office	 	 	 	5.0
	Mechanical
    & Utility Spaces	 	 	 	5.0
	GMP
    Production Room 170	 	 	 	8.5
	Equipment
    Staging / C.O.P Rm	 	 	 	15.55
	Column
    Cleaning / Janitor Room	 	 	 	19.65


 


Where
provided, actual equipment loads will be used.


 


www.protecsinc.com


 




    	24



     


    

 


 


	 	15.6	Exterior
    Loads Criteria


 


Based
on recommended procedures and methods as described in ASHRAE 2012 Fundamentals.


 


	 	15.7	Acoustical
    Criteria


 


The
mechanical systems will be designed to limit the impact of noise in the occupied area to acceptable levels as required by applicable
codes. These NC ratings are “background” ratings (i.e. they are exclusive of noise generated by occupants and their equipment,
such as reactors, freezers and biosafety cabinets). These values are measured in the center of the room, 3 feet above finished floor
and, for laboratories, a minimum of 5 feet away from all fume hoods with the fume hood sash closed.


 


	 	15.8	Expansion
    and Redundancy Considerations


 


There
are no expansion or redundancy considerations; however, specific critical equipment will be connected to back-up power.


 


	 	15.9	Mechanical
    Systems Seismic Restraint Criteria


 


Mechanical
systems will be seismically restrained per minimum code requirements. All mechanical systems will be assigned an importance factor of
1.0.


 


	 	15.10	Systems
    Description (Air-side)


 


15.10.1
Supply Air Systems



 


Supply
air will be delivered to the space via air handling units. A summary listing of the air handling unit components is listed below and
followed by a table identifying the preliminary configuration for the air handling units on the project:


 


All
units will be double wall unless indicated otherwise. The basis for the unit manufacturer is Aaon, Daikin, Liebert, Trane, Carrier, or
approved equal.


 


www.protecsinc.com


 




    	25



     


    

 


 


	AIR
    HANDLING UNIT SECTION TABLE	 
	COMPONENT	 	AHU
    TYPE	 	ENTRY	 	CHEMICAL
    FILTER	 	PREFILTER	 	INTERMEDIATE
    FILTER	 	PREHEAT	 	COOLING	 	FAN	 	REHEAT	 	FINAL
    FILTER	 	INTEGRAL
    HUMIDIFIER	 
	AHU-04	 	Outdoor	 	Mix	 	No	 	30%	 	95%	 	Gas	 	DX	 	AF-P	 	Yes	 	No	 	Yes	 
	AHU-05	 	Outdoor	 	Mix	 	No	 	30%	 	95%	 	Gas	 	DX	 	AF-P	 	Yes	 	No	 	Yes	 
	AHU-06	 	Outdoor	 	Mix	 	No	 	30%	 	95%	 	Gas	 	DX	 	AF-P	 	Yes	 	No	 	Yes	 
	AHU-07	 	Outdoor	 	Mix	 	No	 	30%	 	95%	 	Gas	 	DX	 	AF-P	 	Yes	 	No	 	No	 
	AHU-08	 	Outdoor	 	Mix	 	No	 	30%	 	95%	 	Gas	 	DX	 	AF-P	 	Yes	 	No	 	No	 
	AHU-09	 	Outdoor	 	Mix	 	No	 	30%	 	95%	 	Gas	 	DX	 	AF-P	 	Yes	 	No	 	No	 
	CRU-1
    / CU-1	 	CRAC	 	Mix	 	No	 	30%	 	N/A	 	KW	 	DX	 	FC-C	 	No	 	No	 	Yes	 
	CRU-2
                                            /CU-2
	 	CRAC	 	Mix	 	No	 	30%	 	N/A	 	KW	 	DX	 	FC-C	 	No	 	No	 	No	 


 


AHU
Type


 


Outdoor
– The unit will be an outdoor air handling unit type with a sloped roof, insulation, 2” double wall casing with R13 foam
injected insulation, exterior of unit is painted, no thru-metal construction, full perimeter base rail, outside air inlet with rain hood
and filter magnehelic gauges.


 


CRAC
– The unit will be a computer room air conditioning unit as commonly available from one of the CRAC manufacturers listed above.
The unit will be a direct-expansion cooling type. The condensing unit will be mounted outdoors on a curb. The air handling unit section
will be mounted indoors.


 


Entry


 


Mix
– The outside air or make-up air enters the unit and mixes with the return air in this section. The section has an exterior louver
and dampers on both entry points. The dampers are adjusted and set manually.


 


www.protecsinc.com


 




    	26



     


    

 


 


Filter
Sections (Pre-Filter, Final Filter)


 


30%
- A two-inch ASHRAE 30%, MERV 8 pre-filter will be provided. The filter will fit within the rack in the unit and is accessible via the
section access door. The filters will slide in and out of the rack or the filters will clip in and out of the rack. If a higher efficiency
filter is provided immediately downstream from this filter, both filters will be integral in the rack.


 


95%
- A four-inch ASHRAE 95%, MERV 14 filter will be provided after or with an integral pre-filter noted above. The filters will be cartridge
type. The filter will fit within the rack in the unit and is accessible via the section access door. The filters will slide in and out
of the rack or the filters will clip in and out of the rack.


 


Pre-heat


 


Natural
Gas – 10:1 or better modulating indirect fired natural gas burner and heat exchanger constructed of 300 series stainless steel.


 


KW
- An electric resistance section will provide pre-heat. The electric heating section will have an SCR control to modulate the output.


 


Cooling


 


DX
- A direct-expansion (DX as indicated in the table) coil will provide cooling. The unit will have a variable speed compressor or digital
scroll compressor to provide good capacity control. The coil will have an integral drain pan for condensate. The pan will be sloped to
the unit exterior with a pipe connection. The coil will be coated with Husky Coil Coat BGF-865 or manufacturer recommended equal for
resistance to cleaning chemicals.


 


Hot
Gas Reheat Coil


 


Utilizes
the refrigerant hot gas during dehumidification mode to reheat the air to minimize the use of the zone electric duct heaters.


 


Fan


 


AF-P
– An open plenum or plug fan. This fan section has a septum wall, bell- mouthed inlet, and an open fan wheel enclosed by a wire
metal screen for protection. Fans will be direct drive with VFD. Multiple plenum fans in a single array will be utilized for reliability
and service ease.


 


FC-C
– A scroll housed centrifugal fan with a forward curved blade. The fan is belt driven.


 


www.protecsinc.com


 




    	27



     


    

 


 


Humidifier


 


A
humidifier dispersion manifold is provided within the AHU to distribute steam to the respective zone. Steam is supplied from a gas fired
steam humidifiers. The humidifier will utilize a space located humidity sensor.


 


15.10.2
Air System Requirements



 


Based
on revised preliminary calculations, the projected supply airflows, zoning and type of unit are as follows:


 


	EQUIPMENT
    NO.	 	AREAS
    SERVED	 	APPROXIMATE
    MAX. SUPPLY/RETURN CFM	 	APPROXIMATE
    MINIMUM OA CFM	 	AIR
    DEVICE(S)
	 	 	 	 	 	 	 	 	 
	AHU-04	 	Process
    Area	 	28,400	 	7,100	 	HEPAs
	AHU-05	 	Process
                                            Area
	 	28,400	 	7,100	 	HEPAs
	AHU-06	 	Filling	 	7,500	 	2,500	 	HEPAs
	AHU-07	 	Micro
    Lab	 	1,200	 	430	 	HEPAs
	AHU-08	 	Office
                                            Addition
	 	33,000	 	3,000	 	Diffusers
                                            / Grilles

	AHU-09	 	Laboratory
    & Warehouse Renovation Areas	 	8,000	 	2,000	 	Diffusers
    / Grilles
	CRU-1
    / CU-1	 	Automation
                                            Control
	 	3,750	 	0	 	Diffusers
                                            / Grilles

	CRU-2
    / CU-2	 	Server
                                            Room
	 	885	 	0	 	Diffusers
                                            / Grilles



 


Refer
to the Air Handling Unit zone maps for segregation of areas along with pressurization plans.


 


www.protecsinc.com 


 




    	28



     


    

  


 


The
supply and return ductwork distribution system will be composed of a network of galvanized steel sheet metal duct mains, sub-mains, laterals,
and branches. Dampers will be provided at branch take-offs and diffuser take-offs to facilitate balancing. The ductwork will be constructed
to SMACNA standards with respect to proper metal gauge, reinforcement, fitting construction, longitudinal seams, transverse seams and
sealing. Unless not allowed by code, flexible ductwork will be used to connect to ceiling mounted air distribution devices. All supply
and return sheet metal ductwork in unconditioned spaces will be insulated with a 1.5-inch thick fiberglass wrap.


 


All
production and warehouse ductwork will be delivered cleaned with ends covered and stored on site per SMACNA Duct Cleanliness for New
Construction Guidelines for Advanced Level. The supply ductwork will have a pressure class of +3” W.C. to the VAVs/FTU/Duct Heaters
and a pressure class of +2” W.C. to the diffusers. The the return/exhaust ductwork will have a pressure class of -2” W.C.
or -3” W.C as required.


 


Stainless
steel ductwork will be provided at the drain exhaust hoods, humidifier manifolds, and at short radius low wall exhaust grilles in processing
rooms.


 


Air
will be supplied to the space at the top of the room through room side replaceable HEPAs and extracted from the space through low wall
exhaust grilles in each production room. In the offices and laboratories, air will be supplied and returned via ceiling mounted diffusers.


 


The
production areas will be designed for a room pressurization of 0.05” w.g between all rooms. Validation requirements should have
a broader range (0.03” w.g.).


 


www.protecsinc.com


 




    	29



     


    

 


 


15.10.3
System Operation



 


	AIR
    HANDLING ZONE CONTROL
	COMPONENT	 	ENABLED	 	DISTRIBUTION
    (S / R)	 	ZONE
    HEATING MEANS	 	HUMIDIFIER	 	FLOW
    MEASURE	 	FILTER
    CHECK	 	FAN
    CONTROL	 	NOTES
	AHU-
    04	 	BAS	 	HB/HB	 	KW	 	Unit	 	N/A	 	M	 	VFD	 	Fan
    Speed Set at TAB
	AHU-
                                            05
	 	BAS	 	HB/HB	 	KW	 	Unit	 	N/A	 	M	 	VFD	 	Fan
                                            Speed Set at TAB

	AHU-
    06	 	BAS	 	HB/HB	 	KW	 	Unit	 	N/A	 	M	 	VFD	 	Fan
    Speed Set at TAB
	AHU-
                                            07
	 	BAS	 	HB/HB	 	KW	 	ES	 	N/A	 	M	 	VFD	 	 
	AHU-
    08	 	BAS	 	VAV	 	KW	 	N/A	 	DP	 	M	 	VFD	 	 
	AHU-
                                            09
	 	BAS	 	VAV	 	KW	 	ES	 	DP	 	M	 	VFD	 	 
	CRU-1 
                                            / CU-1
	 	HOA	 	1
    Zone	 	Unit	 	Unit	 	N/A	 	N/A	 	HB	 	 
	CRU-2
                                             / CU-2
	 	HOA	 	1
    Zone	 	Unit	 	N/A	 	N/A	 	N/A	 	HB	 	 


 


Enabled
– This indicates how the unit is enabled – see key below:


 


BAS
– The unit is enabled through the BAS once all safety / status switches are confirmed.


 


HOA
– The unit is enabled through the HOA switch on the starter or VFD and will run after internal safeties wired through the start
contacts are made.


 


Distribution
(Supply / Return) – This indicates how the air is distributed – see key below:


 


1
Zone – This indicates the unit is a single zone constant volume unit. The air flow will be at a constant volume with the supply
air temperature controlled by a sensor located in the zone, zone return air duct, or zone exhaust duct.


 


www.protecsinc.com


 




    	30



     


    

 





 


HB
– This indicates the unit will be hard balanced via dampers to a specific set point with zone reheat coils. The unit will condition
the supply air to a temperature as dictated by the duct mounted temperature sensor. Zone temperature control is accomplished via feedback
from the zone sensors to the reheat coils. Multiple rooms will be included per zone and will be controlled to a critical room control.
On a fall in temperature below the set point, the reheat coil will be energized to satisfy space temperature. Where the HB is indicated
on the return side, this indicates that the return will be hard balanced to a specific set point.


 


VAV
– Variable Air Volume Terminal units with integral heating coils will be utilized as the means to meet the required energy code.


 


Zone
Heating Means – This indicates the heating medium for a zone – see key below:


 


KW
– This indicates the heating coil in the duct or at the VAV or CV box is an electric coil. The coil will have an integral disconnect
and air flow switch. The coil will be SCR controlled.


 


UNIT
– This indicates the heating is provided at the unit.


 


HUMIDIFIER
– This indicates the humidifying means for the air handling system – see key below:


 


ES
– An electro-steam humidifier unit with its own dispersion unit will provide humidification to suit the zones as indicated. Electric
immersion heaters convert domestic water to steam for distribution in the ductwork via a duct mounted dispersion manifold. The humidifier
will have an automatic fill and drain cycle and an integral control panel for these types of safeties. The humidifier controls will include
the zone sensor, an airflow switch, and a high limit sensor. The humidifier control will be via the BAS.


 


UNIT
– This indicates the humidification is provided at the unit.


 


Flow
Measure – This indicates if there is a flow measurement device to measure or control the flow of supply air.


 


DP
– This indicates that a differential pressure switch will be used to confirm air flow in the system via a pressure sensing device
mounted in the duct. It is used to sense if the unit is on or off. If used in an automatic mode, this sensor can be set to a specific
point and provide feedback to the control system to control the fan speed.


 


www.protecsinc.com


 




    	31



     


    

 





 


Filter
Check – This indicates if there is a means provided to check the differential pressure across the unit mounted filters –
see key below:


 


M
– This indicates a magnehelic gauge will be installed across the filters to indicate the pressure drop.


 


Fan
Control – This indicates how the supply or supply and return fans on the system are controlled. – see key below:


 


VFD
– This indicates that the VFD can provide automatic control based on feedback from an air flow monitor or differential pressure
switch. If there is not air flow monitor or pressure sensor, then fan speed will be adjusted manually.


 


MVFD
– This indicates the fan speed will be adjusted manually through the VFD.


 


HB
– This indicates the fan speed will be adjusted during balancing by installing the sheaves to meet the design criteria.


 


15.10.4
Automatic Temperature Controls and Monitoring



 


The
existing Siemens Building Automation System (BAS) will be expanded to provide the HVAC temperature and humidity controls.


 


This
system will utilize feedback sensor input with microprocessor controllers to allow for independent operation of the HVAC systems. All
actuators and operators will be electronic, and of the proportionally modulating type with feedback capabilities. All control components
and end devices located within cGMP spaces will be of industrial type, high accuracy, factory calibrated and field adjustable/calibrateable.
Standard BAS controllers and instrumentation will be supplied where possible. The below is a general controls approach for all non-process
controlled systems:


 


	 	1.	Cleanroom
    Area


 


	 	a.	RTU-1/RTU-2
    (Correct Tag – AHU-4/AHU-5)



 




	 	i.	DAT
    control (Sensor Factory Installed In Unit) (DAT set point: 55F)
	 	ii.	Supply
    fan control (manually set VFD)
	 	iii.	Return
    fan control (manually set VFD)


 


www.protecsinc.com


 




    	32



     


    

 


 


	 	iv.	(Dehumidification
    set point 60%RH) (2 RH sensors in GMP Production#170, 1 RH sensor Weigh Room #171, 1 RH sensor Commodity Prep #172) Wall mounted,
    wash down/cleanroom rated sensors will be furnished and installed by BAS subcontractor and connected to BAS. BAS to send highest
    RH reading to RTU. False readings will be disregarded.
	 	v.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points and control inputs)
	 	vi.	Supply
    & Return Smoke detectors to be provided with AHU and factory installed.
	 	vii.	Supply
    and return air smoke isolation damper to be furnished by sheet metal subcontractor and wired to unit controller. Isolation damper
    will be controlled by AHU controller.
	 	viii.	No
    economizer.


 


	 	b.	GFH-1/H-1,
    GFH-2/H-2



 




	 	i.	(2
                                            RH sensors in GMP Production#170, 1 RH sensor Weigh Room #171, 1 RH sensor Commodity Prep
                                            #172) Wall mounted, wash down/cleanroom rated sensors will be furnished and installed by
                                            BAS subcontractor and connected to BAS. BAS to send RH reading furthest from set point to
                                            each humidifier. False readings will be disregarded. Both humidifiers will be controlled
                                            by same signal.

    

	 	ii.	Duct
    high limit sensor (sensor purchased with humidifier, installed in supply ductwork and wired to humidifier controller by sheet metal
    subcontractor)
	 	iii.	Air
    proving switch (switch purchased with humidifier, installed in supply ductwork and wired to humidifier controller by sheet metal
    subcontractor)
	 	iv.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points and control inputs) (Humidification Set Point
    40%RH)


 


www.protecsinc.com


 






    	33



     


    

 


 


	 	c.	EHC-149,
    EHC-164, EHC-165, EHC-167, EHC-169, EHC- 170-A, EHC-170-B, EHC-170-C, EHC-170-D, EHC-171, EHC-172, EHC-173, EHC-173A, EHC-175,
    EHC-156, EHC- 176



 




	 	i.	Temperature
    Sensors (Furnished & installed in space by BAS subcontractor, wall mounted near monitoring system temp sensor, wash down/cleanroom
    rated sensor, calibratable, 1 sensors per duct heater, +/-1F accuracy by BAS Subcontractor)
	 	ii.	Duct
    Heaters purchased with SCR controls. Duct heater output commanded through BAS. (Duct heater set point 68F, set point will be entered
    in BAS)
	 	iii.	Air
    proving switch included integral with the duct heater.


 


	 	2.	Filling
    Cleanroom Area


 


	 	d.	RTU-3
    (Correct Tag – AHU-6)



 




	 	i.	DAT
    control (Sensor Factory Installed In Unit) (DAT set point: 55F)
	 	ii.	Supply
    fan control (manually set VFD)
	 	iii.	Return
    fan control (manually set VFD)
	 	iv.	Dehumidification
    set point 60%RH (1) wall mounted wash down/cleanroom rated sensor will be furnished and installed by BAS subcontractor and connected
    to BAS. BAS will send space RH reading to RTU through Bacnet.
	 	v.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points, input values)
	 	vi.	Supply
    & Return Smoke detectors to be provided with AHU and factory installed.
	 	vii.	No
    economizer.


 


	 	e.	GFH-3/H-3



 




	 	i.	(1)
    Wall mounted wash down/cleanroom rated sensor will be furnished and installed by BAS subcontractor and connected to BAS. BAS will
    send space RH reading to RTU through Bacnet.
	 	ii.	Duct
    high limit sensor (sensor purchased with humidifier, installed in supply ductwork and wired to humidifier controller by sheet metal
    subcontractor)
	 	iii.	Air
    proving switch (switch purchased with humidifier, installed in supply ductwork and wired to humidifier controller by sheet metal
    subcontractor)
	 	iv.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points, send control value) (Humidification Set Point
    40%RH)


 


www.protecsinc.com


 







    	34



     


    

 





 


	 	v.	EHC-168,
    EHC-168B
	 	vi.	Temperature
    Sensors (Furnished & installed in space by BAS subcontractor, wall mounted near monitoring system temp sensor, wash down rated
    sensor, 1 sensors per duct heater, +/-1F accuracy)
	 	vii.	Duct
    Heaters purchased with SCR controls. Duct heater output commanded through BAS. (Duct heater set point 65F, set point will be entered
    in BAS)
	 	viii.	Air
    proving switch included integral with the duct heater.


 


	 	3.	MicroLab


 


	 	f.	RTU-4
    (Correct Tag – AHU-7)


 


	 	i.	DAT
    control (Sensor Factory Installed In Unit) (DAT Set Point: 55F)
	 	ii.	Supply
    fan control (manually set ECM Motor)
	 	iii.	Dehumidification
    set point 60%RH (1) wall mounted sensor located near monitoring system will be furnished and installed by BAS subcontractor and connected
    to BAS. BAS to send value to RTU through Bacnet.
	 	iv.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points and control value)
	 	v.	Duct
    smoke detector to be furnished and wired by FA subcontractor, installed in ductwork by sheet metal subcontractor
	 	vi.	No
    economizer.


 


	 	g.	HUM-1
    (Generation Unit to be Located in Lab Water Room #143)


 


	 	i.	(1)
    Wall mounted sensor will be furnished and installed by BAS subcontractor and connected to BAS. BAS to send RH reading to the humidifier.
	 	ii.	Duct
    high limit sensor (sensor purchased with humidifier, installed in supply ductwork and wired to humidifier controller by sheet metal
    subcontractor)
	 	iii.	Air
    proving switch (switch purchased with humidifier, installed in supply ductwork and wired to humidifier controller by sheet metal
    subcontractor)
	 	iv.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points) (Humidification Set Point 40%RH)


 


www.protecsinc.com


 




    	35



     


    

 


 


	 	h.	EHC-119


 


	 	i.	Temperature
    Sensor (Furnished & installed in space, wall mounted near monitoring system temp sensor, 1 sensors per duct heater, +/-1F accuracy
    by BAS Subcontractor)
	 	ii.	Duct
    Heaters purchased with SCR controls. Duct heater output commanded through BAS. (Duct heater set point 70F, set point will be entered
    in BAS)
	 	iii.	Air
    proving switch included integral with the duct heater.


 


	 	4.	Office
    Area


 


	 	i.	RTU-5
    (Correct Tag – AHU-8)


 


	 	i.	DAT
    control (Sensor Factory Installed In Unit) (DAT Set Point: 55F)
	 	ii.	Supply
    fan control (Duct static pressure sensor purchased with RTU, installed In supply ductwork & wired to unit controller by sheet
    metal subcontractor)
	 	iii.	Return
    fan control (Building pressure sensor purchased with RTU, installed in ceiling and wired to unit controller by sheet metal subcontractor)
	 	iv.	Dehumidification
    control (sensor purchased with RTU, Installed In Return Air Ductwork and wired to unit controller by sheet metal subcontractor) (Dehumidification
    set point 55%RH)
	 	v.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points)





	 	vi.	Supply
    & Return Smoke detectors to be provided with AHU and factory installed.
	 	vii.	Economizer
    (Enthalpy control, factory installed sensor)


 


	 	b)	VAV-1,
    VAV-2, VAV-2, VAV-3, VAV-4, VAV-5, VAV-6, VAV- 7, VAV-8, VAV-9, VAV-10, VAV-11, VAV-12, VAV-15, VAV- 16, VAV-107


 


	 	i.	Temperature
    Sensor (Furnished & Installed in space, wall mounted, 1 per heater, sensor +/-2F accuracy by BAS Subcontractor)(VAV with no heater
    shall be controlled by shared sensor in space)
	 	ii.	VAV
    Heaters Command by BAS. (Duct heater set point 70F)
	 	iii.	Air
    proving switch furnished with VAV.
	 	iv.	VAV
    Controls provided by BAS Subcontractor.


 


www.protecsinc.com


 




    	36



     


    

  


 


	 	c)	VAV-M-1,
    VAV-M-2


 


	 	i.	Constant
    Volume, controls by BAS subcontractor.


 


	 	d)	FTU-1,
    FTU-2, FTU-3, FTU-4, FTU-5, FTU-7, FTU-8, FTU-9, FTU-10, FTU-11, FTU-12, FTU-13, FTU-14, FTU-15


 





	 	i.	Temperature
    Sensor (Furnished & Installed in space, wall mounted, 1 per heating sensor +/-2F accuracy by BAS Subcontractor)
	 	ii.	FTU
    Heaters Command by BAS. (Duct heater set point 70F)
	 	iii.	Air
    proving switch furnished with FTU.
	 	iv.	FTU
    Controls provided by BAS Subcontractor.


 


	 	5.	Lab
    Area


 


	 	b.	RTU-6
    (Correct Tag – AHU-9)


 


	 	i.	DAT
    control (Sensor Factory Installed In Unit) (DAT Set Point: 55F)
	 	ii.	Supply
    fan control (Duct static pressure sensor purchased with RTU, installed In supply ductwork & wired to unit controller by sheet
    metal subcontractor)
	 	iii.	Return
    fan control (Building pressure sensor purchased with RTU, installed in ceiling and wired to unit controller by sheet metal subcontractor)
	 	iv.	Dehumidification
    control (sensor purchased with RTU, Installed In Return Air Ductwork and wired to unit controller by sheet metal subcontractor) (Dehumidification
    set point 55%RH)
	 	v.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points)
	 	vi.	Supply
    & Return Smoke detectors to be provided with AHU and factory installed.
	 	vii.	Economizer
    (Enthalpy control, factory installed sensor)


 


	 	c.	HUM-2
    (Generation Unit to be Located in Lab Water Room #143)


 


	 	i.	(1)
    Wall mounted sensor will be furnished and installed by BAS subcontractor and connected to BAS. BAS to send RH reading to the humidifier.
	 	ii.	Duct
    high limit sensor (sensor purchased with humidifier, installed in supply ductwork and wired to humidifier controller by sheet metal
    subcontractor)


 


www.protecsinc.com


 




    	37



     


    

 





 


	 	iii.	Air
    proving switch (switch purchased with humidifier, installed in supply ductwork and wired to humidifier controller by sheet metal
    subcontractor)
	 	iv.	BacNET
    card for interface to BAS System (BAS to monitor unit function and input set points and space reading) (Humidification Set Point
    40%RH)


 


	 	d.	VAV-139,
    VAV-143, VAV-123, VAV-118, VAV-121, VAV- 105, VAV-150, VAV-148, VAV-156


 


	 	i.	Temperature
    Sensor (Furnished & Installed in space, wall mounted, 1 per heater, sensor +/-2F accuracy by BAS Subcontractor)
	 	ii.	VAV
    Heaters Command by BAS. (Duct heater set point 70F)
	 	iii.	Air
    proving switch furnished with VAV.
	 	iv.	VAV
    Controls provided by BAS Subcontractor.


 


	 	6.	Boiler
    B-1


 


	 	e.	Stand
    Alone factory controls.
	 	f.	Boiler
    Trouble Alarm tied into BAS
	 	g.	Feed
    water Trouble Alarm tied into BAS


 





	 	7.	EF-1,
    EF-2, EF-3, EF-6, EF-8, EF-9, EF-10, EF-11, EF-12


  


	 	h.	Hard
    Balanced (Manually Set ECM)
	 	i.	EFs
    Status tied into BAS System (Line voltage/current sensor furnished, installed and wired by BAS subcontractor)


 


	 	8.	EF-5


 


	 	j.	Hard
    Balanced (Manually Set ECM)
	 	k.	Not
    connected to BAS


 


	 	9.	EF-7


 


	 	l.	Hard
    Balanced (Manually Set ECM)





	 	m.	EFs
    Status tied into BAS System (Line voltage/current sensor furnished, installed and wired by BAS subcontractor)
	 	n.	Hydrogen
    Gas Alarm tied into BAS System (Hydrogen sensor furnished, installed and wired by BAS subcontractor)


  


	 	10.	SF-4-1,
    SF-4-2



 




	 	o.	Stand
    Alone Controls – Control Sensors Furnished and Installed by Sheet Metal Subcontractor.


 


	 	11.	Electric
    Cabinet Unit Heaters (CUH-1, CUH-2, CUH-3)


 


	 	p.	Stand
    Alone Controls – Control Sensors Furnished and Installed by Sheet Metal Subcontractor.


 


www.protecsinc.com


 




    	38



     


    

 


 


	 	12.	Condensate
    Pumps (CP-1, CP-2)


 


	 	q.	Stand
    Alone Controls – Control Sensors Furnished and Installed by Sheet Metal Subcontractor.


 


	 	13.	NG
    Unit Heater (GUH-1)


 


	 	r.	Stand
    Alone Controls – Control Sensors Furnished and Installed by Sheet Metal Subcontractor.


 


	 	14.	NG
    Unit Heater (GUH-2) (Roof Mounted)


 


	 	s.	Stand
    Alone Controls – Control Sensors Furnished and Installed by Sheet Metal Subcontractor. BAS subcontractor to connect to MAU
    to send an enable command that is tied to the generator operation. MAU to run only when normal power is lost.


 


	 	15.	Electric
    Unit Heaters (EUH 1-1, EUH 1-2)


 


	 	t.	Stand
    Alone Controls – Control Sensors Furnished and Installed by Sheet Metal Subcontractor.


 


	 	16.	CRAC
    Units (CRU-1/CU-1)


 


	 	u.	Stand
    Alone Controls – Control Sensors Furnished and Installed by Sheet Metal Subcontractor.
	 	v.	BAS
    Connection through BacNET interface. (Monitoring & Alarming by BAS Only)


 


	 	17.	Chilled
    Water System


 


	 	w.	Stand
    alone existing chiller controls shall be utilized to operate chiller to maintain temperature. Piping subcontractor to furnish and
    wire temperature controlling sensors.
	 	x.	BAS
    subcontractor shall furnish control sensors and valves for installation by piping subcontractor. Control valves and sensor will be
    wired by BAS Subcontractor.
	 	y.	Chilled
    Water system pumps and associated VFDs shall be furnished by Piping subcontractor and will be wired to BAS system by BAS subcontractor
    for control by BAS system.
	 	z.	Use
    point control valves shall be furnished by Process Automation Controls subcontractor for installation by piping subcontractor. Process
    Automation Control devices and sensors will be wired by Process Automation subcontractor.


 


	 	18.	Waste
    Neutralization


 


	 	aa.	Stand
    alone controls. Plumbing subcontractor shall receive and install controls purchased with waste neutralization system.
	 	bb.	Trouble
    Alarm tied into BAS (Wiring by BAS Subcontractor)



 




	 	19.	Generator


 


	 	cc.	Stand
    Alone controls. Controls furnished with generator, installed and wired by Electrical subcontractor.


 


www.protecsinc.com


 




    	39



     


    

 





 


	 	dd.	Trouble
    Alarm tied into BAS (Wiring by BAS Subcontractor) 
	 	ee.	Run
    status tied to BAS for control of MAU.


 


	 	20.	Bulk
    Nitrogen


 


	 	ff.	Stand
    Alone Controls furnished and installed by Owner’s vendor.
	 	gg.	Trouble
    Alarm tied into BAS (Wiring by BAS Subcontractor)


 


	 	21.	High
    Pressure Nitrogen


 


	 	hh.	Pressure
    Alarm sensor furnished by BAS subcontractor, installed by plumbing subcontractor and wired by BAS subcontractor.


 


	 	22.	Air
    Compressor


 


	 	ii.	Stand
    Alone controls. Controls furnished with Air Compressor and installed and wired to compressor controller by plumbing subcontractor.
	 	jj.	Trouble
    Alarm tied into BAS (Wiring by BAS Subcontractor)


 


	 	23.	VAC


 


	 	kk.	Stand
    Alone controls. Controls furnished with Vacuums and installed and wired to vacuum controller by plumbing subcontractor.
	 	ll.	Trouble
    Alarm tied into BAS (Wiring by BAS Subcontractor)


 


	 	24.	Cold
    Boxes


 


	 	mm.	Stand
    Alone controls furnished and installed by Cold Box subcontractor. No connection to BAS system.


 


	 	25.	Existing
    Loading Dock (FN-8-1, FN-8-2)


 


BAS
subcontractor will extend existing controls to new locations and modify as required for separate system operation. Existing pneumatic
controls to be re-used to the greatest extent possible.


 


A
separate building monitoring system that will be CFR 21, Part 11 compliant will be provided. This system will be separate from the BAS
system. The monitoring system will monitor temperature, humidity and pressure in classified areas as indicated on the contract drawings.


 


	 	15.11	Systems
    Description – Exhaust and Supply Fans


 


15.11.1
Toilet Areas (EF-5)



 


The
toilet areas will be served by spun aluminum mushroom cap exhaust fans with integral backdraft dampers. These will be connected to the
toilet areas via a galvanized duct system and exhaust air grilles.


 


www.protecsinc.com


 




    	40



     


    

 





 


15.11.2
Chemical Storage Exhaust (EF-2)



 


An
exhaust fan will be provided in a utility fan set arrangement, upblast discharge with an exhaust stack. The fan will be mounted on rails
on the roof. The fan will be similar to those manufactured by Twin City, Greenheck, Peerless or approved equal. The fan will run at a
constant speed. There is not a redundant fan in the system. The exhaust ducts for this system will be for room exhaust only. The exhaust
duct will be galvanized steel sheet metal duct constructed to a 2.0” pressure classification.


 


15.11.3
Fumehood Exhaust (EF-1)



 


An
exhaust fan will be provided in a utility fan set arrangement, upblast discharge with an exhaust stack. The fan will be mounted on rails
on the roof. The fan will be similar to those manufactured by Twin City, Greenheck, Peerless or approved equal. The fan will run at a
constant speed. There is not a redundant fan in the system. The exhaust ducts for this system will be for room exhaust only. The exhaust
duct will be galvanized steel sheet metal duct constructed to a 2.0” pressure classification.


 


15.11.4
Column Clean Rm. 175 (EF-3)



 


An
exhaust fan will be provided in a utility fan set arrangement, upblast discharge with an exhaust stack. The fan will be mounted on rails
on the roof. The fan will be similar to those manufactured by Twin City, Greenheck, Peerless or approved equal. The fan will run at a
constant speed. There is not a redundant fan in the system. The exhaust ducts for this system will be for room exhaust only. The exhaust
duct will be galvanized steel sheet metal duct constructed to a 2.0” pressure classification.


 


15.11.5
Utility Room Rm 184 (EF-4.1 & 4.2)



 


Regular
aluminum, curb mounted supply fans with inlet filters and integral backdraft dampers will be utilized. Fans will be thermostatically
controlled for summer time ventilation to maintain temperature.


 


15.11.6
Process Room Mechanical Chases (EF-6)



 


A
spun aluminum, curb mounted exhaust fan with integral backdraft dampers will be utilized to remove the moist air associated with the
CIP waste vapor removal. The fan will run constantly and be of the upblast discharge arrangement.


 


15.11.7
Battery Charging Station (EF-7)



 


A
spun aluminum, curb mounted exhaust fan with integral backdraft dampers will be utilized to remove the hydrogen generated during lift
truck battery recharging. The fan will run constantly and be of the upblast discharge arrangement.


 


www.protecsinc.com


 




    	41



     


    

 


 


15.11.8
COP Room (EF-8)



 


A
spun aluminum, curb mounted exhaust fan with integral backdraft dampers will be utilized to help remove all residual moisture and particles
associated with the COP operations. The fan will run constantly and be of the upblast discharge arrangement.


 


15.11.9
Weigh Room General Exhaust Fan (EF-9)



 


A
spun aluminum, curb mounted exhaust fan with integral backdraft dampers will be utilized to help remove particles associated with the
weighing operations and prevent return to the main AHU. The fan will run constantly and be of the upblast discharge arrangement. Fan
will connect to the built in slot hood installed in the dispensing enclosure.


 





15.11.10
COP 177A (EF-11)



 


A
spun aluminum, wall mounted exhaust fan with integral backdraft dampers will be utilized to help remove all residual moisture and particles
associated with the COP operations. The fan will run constantly.


 


15.11.11
QC Lab Suite General Exhaust Fan (EF-12)



 


A
new utility set exhaust fan similar to existing installed on the existing fan support dunnage serving the expanded QC Lab Suite.


 


15.11.12
Column Packing Exhaust Arm Exhaust Fan (EF-10)



 


Relocated
axial fan and exhaust hood/arm system discharging through roof with a stack to 10’ above the roof.


 


	 	15.12	Central
    Utility System Descriptions


 


The
following plant utility systems will provide full capacity for the new Manufacturing Suites:


 


	 	●	Plant
  Steam and Condensate System (Tied Into Existing System) 



 


A detailed description of the systems follows:


 



15.12.1
Chilled Water System



 


See
division 17.0 for details.


 





15.12.2
Plant Steam and Condensate System



 


The
existing 80 HP boiler will remain.


 


www.protecsinc.com


 




    	42



     


    

 


 


One
(1) new 50 HP gas fired, Low-pressure boiler will be provided. The boiler will be packaged fire tube type, including a forced draft,
natural gas fired power burner and control panel. The boiler package will be provided with all code required safety devices; controls,
fuel train and flex connections. The system will tie into a common distribution header with the existing to serve the process equipment.


 


15.12.2.2
System Operation



 


The
new boiler will be controlled by factory provided stand-alone controls. A trouble alarm will be connected to the plant BAS system.


 


15.12.2.3
Steam and Condensate Distribution System



 


The
system will utilize two-way modulating control valves. Isolation valves, coil valve rig by-passes, strainers, vents, drip legs, traps,
expansion provisions, and temperature and pressure read-out devices will be included in this piping. Gate valves with union bonnets will
be used in all piping 2” and smaller, OS&Y gate valves will be used in all piping 2 1⁄2” and larger. Isolation valves
will be provided in all branch/take-off lines. All valves will be tagged and piping runs labeled at twenty-foot intervals and all changes
in direction. The condensate piping will be schedule 80.


 


The
steam piping material 2 1⁄2” and larger will be carbon steel schedule 40 with welded fittings. Piping 2” and smaller
will be schedule 40 carbon steel with screw fittings. Screw fittings will not be used over the production area; socket weld or butt weld
pipe and fittings will be used.


 


All
steam piping will be insulated with fiberglass and have a pre-formed ASJ cover. Where this insulation is exposed to a cleanroom air stream;
the jacket will be covered with PVC or epoxy painted. Ball joints or expansion joints will be used in conjunction with expansion loops
in the piping to control expansion. Roller hangers will be used where appropriate.


 


www.protecsinc.com


 




    	43



     


    

 


 


	 	15.13	PLUMBING


 


This
section is dedicated to the description of the proposed Plumbing/Laboratory and Process Utilities Piping Systems for the project. Systems
will be designed in accordance with the latest applicable codes, standards and authorities having jurisdiction. The balance of this section
discusses the extension of the water systems to serve the process equipment and the new compressed air, vacuum, bulk nitrogen system
and process waste.


 


Plumbing/Laboratory
and Process Systems:


 


	 	●	Domestic
    Cold Water
	 	●	Domestic
    Hot water
	 	●	Laboratory/Process
    Cold Water (Non-Potable Cold Water)
	 	●	Laboratory/Process
    Hot Water (Non-Potable Hot Water)
	 	●	Tepid
    water for safety shower eyewash stations
	 	●	House
    nitrogen
	 	●	Clean
    dry air
	 	●	Natural
    gas piping
	 	●	DI
    water
	 	●	Vacuum
	 	●	Sanitary
    drainage
	 	●	Process
    Waste System


 


The
following sections describe the approach for the project’s plumbing, laboratory and process utility piping systems.


 


15.13.1
General



 


	 	●	Sleeves
    will be provided for piping penetrations at walls, floors, and roofs of mechanical areas. Floor sleeves will extend above finished
    floor in exposed areas and will be flush with floor when concealed in walls.
	 	●	The
    new plumbing fixtures, equipment and systems will be installed and located as shown on the architectural plans with ADA compliance
    as indicated.
	 	●	All
    piping penetrations through fire rated walls and floors will be caulked and sealed with a fire-stopped material to maintain the fire
    rating integrity.
	 	●	All
    utility services will be valved for branch-to-header connections and at all points of use and to allow isolation of equipment for
    maintenance and modifications. Access will be provided to the valves.
	 	●	The
    design criteria that will be used for water calculations are 66 psig static pressure and 63 psig residual pressure at 1,280 GPM.
	 	●	The
    design criteria that will be used for the natural gas system is 25-99 psig street pressure with a pressure reducing valve supplying
    5 psig into the building.


 


www.protecsinc.com


 




    	44



     


    

 





 


15.13.1.1
Seismic Restraint Criteria



 


	 	●	Piping
    systems will be seismically restrained per minimum code requirements (see Structural Section). Any systems that require restraint
    and the applicable industry standards will be identified.


 


15.13.1.2
Maintainability Criteria



 


	 	●	A
    primary goal of the new facility is to isolate the routine maintenance access to laboratory and process support systems from lab/process
    primary circulation. Access to all terminal devices serving laboratory and process spaces in the new facility will be located outside
    of the lab/process envelope.


 


15.13.1.3
Expansion Criteria



 


	 	●	No
    provisions will be made for future expansion in the new facility.


 


15.13.2
Systems Description



 


15.13.2.1
Water Systems



 


	 	●	The
    domestic water system will be supplied from a connection to the existing water main service located in the service entrance mechanical
    room. The domestic water system will supply cold-water to plumbing fixtures, equipment and the laboratory/process water system.
	 	●	The
    water service will be designed to provide water to the building’s fixtures and equipment at a minimum pressure of 40 psig at
    the most remote point. Maximum pressure will not exceed 80 psig at a fixture and distribution and flow velocity will not exceed 8
    fps. The buildings service main size is anticipated to be 4” diameter. Pending final water pressure data, it is not anticipated
    that a water booster system will not be required.
	 	●	The
    building’s water system is isolated from the municipal water system by a reduced pressure zone backflow preventer assembly.
    The domestic and process water systems located downstream of the water meter will each incorporate their own backflow preventers
    sized at 100% of the design load. The process water systems will be designed to be a dedicated building system that will be isolated
    from the domestic water system. The lab/process cold water supply will be a non-potable water system supplying cold water to the
    laboratory and process water consuming fixtures and equipment. The non-potable water system will also supply the lab/process non-potable
    hot water system.


 


www.protecsinc.com


 




    	45



     


    

 


 


	 	●	A
    new domestic electric hot water heater will be provided for the fit- out. Domestic hot water will be generated at 140°F and distributed
    at 120°F. The domestic hot water system will incorporate a master digital type thermostatic mixing valve that will reduce water
    temperatures to the desired system distribution temperature of 120°F. The hot water heater will be located within the Janitors
    Closet 161A. The 120°F water system is anticipated to be a re-circulated system, which will be returned back to the generation
    heater.
	 	●	All
    safety shower and eye wash equipment will be supplied with tepid water from the existing emergency safety thermostatic mixing valve
    located in utility room 125.


 


All
water piping will be distributed in type “L” copper tubing, hard drawn, ASTM B88, with 95/5tin antimony silver soldered joints
on piping 2 1⁄2” and smaller and grooved coupling with rolled grooved joints on piping 3” and larger. Valves will be
two piece full port ball valves on piping 3” and OS&Y gate valves on piping 4” and larger. All piping will be insulated
using fiberglass insulation. A PVC exterior jacket will be applied to all domestic water piping when exposed to view in finished areas
and exterior building areas.


 


15.13.2.2
Drainage



 


This
project will require modifications to the existing facility sanitary and process drainage systems.


 


Storm
Drainage


 


	 	●	This
    project will not require modifications to the existing facility storm drainage system.


 


Sanitary


 


	 	●	The
    sanitary waste and vent system will be extended to new domestic fixtures and equipment locations to support the renovations. Plumbing
    fixtures will be drained by gravity through soil, waste and vent stacks, building drains and building sewers to the building main
    sanitary sewer.
	 	●	All
    fixtures including trench drains and floor drains will be trapped and vented to atmosphere. Vents will be extended through the roof.
    Sanitary waste will not be treated.
	 	●	Waterless
    trap primers (trap guards) will be provided at floor drains and trenches not having daily water flow.


 


www.protecsinc.com


 




    	46



     


    

 


 


	 	●	The
    sanitary waste system will be designed to maintain a minimum velocity of 2 fps. The sanitary vent system will be designed so that
    the differential pressure at any point in the building does not exceed 1 inch water column.
	 	●	Floor
    drains will not be provided within immediate location of emergency showers.
	 	●	Below
    ground sanitary waste and vent piping will be Schedule 40 PVC DWV with drainage pattern fittings and solvent cement joints. Above
    ground sanitary waste and vent piping will be Schedule 40 PVC DWV with drainage pattern fittings and solvent cement joints.
	 	●	Sanitary
    piping receiving heating boiler condensate discharge and loading dock washdown shall be ductile iron pipe and DWV fittings meeting
    AWWA C110/A21.10 and push on joints ASTM A 746.


 


Process
Waste


 


	 	●	Floor
    drains in the process area and process equipment will be drained to a separate process waste system. The process waste system will
    drain through dedicated waste and vent stacks, building drains and building sewers to the facility process waste system. The process
    waste will be run by gravity to a sump basin where it will be pumped to a central neutralization system.
	 	●	The
    process waste system will be designed to maintain a minimum velocity of 2 fps. The process vent system will be designed so that the
    differential pressure at any point in the building does not exceed 1 inch water column.
	 	●	A
    pH monitor with chart recorder will be located where the process waste main discharges from the neutralization equipment. The neutralization
    system will have a “trouble” alarm tied into the facility BAS system.
	 	●	All
    waste stream discharge temperatures will be controlled and discharged at <140°F prior to discharging to the below ground waste
    system.
	 	●	Floor
    drains located in the process area will be fitted with solid type 304 stainless steel tops incorporating neoprene rubber gaskets
    continuous around perimeter of solid top. Removal of the solid tops shall be accomplished by a hand held suction device. Floor drains
    located in ventilated shafts that receive drain down discharge from GMP areas will be open with no installed top.
	 	●	Below
    ground process waste and vent piping will be Schedule 40 CPVC DWV with drainage pattern fittings and solvent cement joints. Above
    ground process waste and vent piping will be Schedule 40 CPVC DWV with drainage pattern fittings and solvent cement joints.


 


www.protecsinc.com


 




    	47



     


    

 





 


	 	●	Process
    waste discharge rates from the C-800 and C-900 CMP areas is based on a combined instantaneous flow rate of 32 gallons per minute
    (GPM) based on gravity flow.


 


Neutralization
System


 


	 	●	C-500
    process waste neutralization system is existing and will remain unchanged.
	 	●	The
    facility will be fitted with a new neutralization skid equipped to handle 32 GPM peak flow and adjust pH prior to discharging to
    the municipal street sewer.
	 	●	The
    neutralization system will incorporate a two (2) tank system that will be programmed to balance the pH settings between tanks with
    the final pH discharge set between 6-9. The tanks shall be provided for a chemical neutralization maintaining a discharge pH range
    between 6-9 with both acid and caustic injection. The neutralization system shall be equipped with a sampling port prior to the final
    connection to the sanitary sewer system. The neutralization system shall be an automatic system with self regulating caustic and
    acid injection pumps adjusting pH ranges that will be acceptable to the municipal waste water treatment plant. PH shall be monitored
    between each storage tank and final discharge running trap.
	 	●	The
    acid and caustic supply lines will be installed in an open ended containment pipe that will be drained back to the neutralization
    tanks. The intent of the containment pipe is to prevent line breakage and reconnection of tank supplies from coming in contact with
    personnel.
	 	●	The
    neutralization system main control panel will be provided with a common trouble alarm that will be monitored and supervised by the
    building BAS system.
	 	●	The
    process gravity waste system shall be collected by a single underslab fiberglass vertical basin with a steel top with individual
    pump removal access hatches. The steel top shall be anchored and gasket to the finished floor. The basin will incorporate duplex
    stainless steel pumps that will be sized to handle flow and pressure discharged from the process equipment.
	 	●	The
    sump basin stainless steel pumps will pump waste effluent to the neutralization stage one tank where it will begin to neutralize
    the effluent.


 


www.protecsinc.com


 




    	48



     


    

 


 





	 	●	The
    waste water sump pumps will be controlled for both lead/lag/emergency on (two pumps running) and automatic telemetry that will be
    controlled by a main pump control panel.
	 	●	The
    interior basin effluent level system will be controlled by a float system that will control pump on/off, emergency on (pump No.2)
    and high water alarm signals. The alarm signals will be remote to the pump control panel.


 


15.13.2.3
Plumbing Fixtures and Equipment



 


	 	●	All
    plumbing fixtures will be selected in accordance with water conservation codes and ADA standards.
	 	●	Water
    Closets: 1.28 gpf water-saver, vitreous china wall-hung siphon jet type. Flush valve will be battery powered sensor operated.
	 	●	Urinals:
    0.125 gpf water-saver, vitreous wall-hung washout type flush valves. Flush valve will be battery powered sensor operated.
	 	●	Lavatories:
    Wall-hung or countertop type units, with 1 gpm restricted flow faucets receiving separate hot and cold water supplies. Faucets will
    be battery operated. The faucet operation will have a maximum water flow duration of 30 seconds giving a flow usage of 0.17 gallons.
	 	●	Break
    Room Sinks: Countertop type units, with 2.5 gpm restricted flow faucets.
	 	●	Equipment
    Staging / COP Scullery Sink: Floor mounted, 24-inch x 36-inch x 17-inch deep single bowl with two 24-inch integral drainboards,
    stainless steel sinks with no integral faucets (water supplied via WFI drop).
	 	●	Commodity
    / Equipment Prep Scullery Sink: Floor mounted, 24-inch x 24- inch x 17-inch deep single bowl with two 24-inch integral drainboards,
    stainless steel sinks with no integral faucets (water supplied via WFI drop).
	 	●	Aseptic
    Equipment Prep Scullery Sink: Floor mounted, 20-inch x 20- inch x17-inch deep single bowl with right side 24-inch integral drainboard,
    stainless steel sinks with 1⁄2 gpm restricted flow hand- operated faucets with wrist blade handles and gooseneck spout.
	 	●	Mop
    Receptors: Terrazzo type with wall mounted hose-end type faucet, complete with vacuum breaker and pail hook.
	 	●	Safety
    Shower & Eyewash: Speakman SE-1200 or 1255. Floor drains will be provided at locations were underground work is already being
    done.
	 	●	Drinking
    Foutains: Wall hung electric water cooler, barrier free for handicapped use.


 


www.protecsinc.com


 




    	49



     


    

 


 





15.13.2.4
Compressed Air



 


	 	●	The
    existing reciprocating compressor will be demolished.
	 	●	The
    existing 90 scfm compressor and dryer will remain.
	 	●	A
    new air system will provide 225 scfm of compressed air. The new system will be tied into a distribution manifold to supplement the
    existing compressor and extend from the new manifold to all use points. Compressed air will be generated at 110 psig to provide air
    at building use points at the pressure required.
	 	●	The
    compressed air system will be located in the utility space. The compressed air system will consist of an air-cooled, two stage, oil-
    free rotary screw compressor, duplex pre-filters, simplex final filter, existing receiver tank (390 gal), desiccant dryer and associated
    controls. Compressed air will be filtered and dried to a –40 degree F pressure dew point. Air will then be filtered through
    an after filter and a final filter with a 0.2 micron removal rating.
	 	●	All
    compressed air filters at generation will be sized to handle 100% of the daily calculated load of 225scfm.
	 	●	Compressed
    air piping shall be delivered to the rooms at 100 psi.
	 	●	Piping
    will run above the 1st floor ceiling and drop down to equipment locations along the wall, terminating at a quarter turn
    ball valve.
	 	●	Piping
    material will be type “L” hard drawn copper with nitrogen purged brazed joints. Joints will be brazed (BcuP Series brazing)
    without flux, while being brazed all joints will be continuously purged with an inert gas to prevent the formation of scale. Valves
    will two-piece full port ball valves. All piping, fittings, valves, and accessories will be provided cleaned for oxygen service.
	 	●	Type
    316L stainless steel piping with swage lock compression fitting will be provided within the GMP process areas.
	 	●	Compressed
    air piping system will be sized based on 1 scfm per outlet or the outlet requirements. Diversity factors will be applied to laboratory
    outlets as indicated below.


 


www.protecsinc.com


 




    	50



     


    

 


 


	Table
                                            2


Compressed
Air System Diversity Factors



	Number
                                            of

                                                                                Outlets
	 	Diversity

    Factor
	 	Minimum
                                            Flow

    (scfm)
	 	Empirical
                                            Formula for Flowrate

    (scfm)

	1-5	 	1.00	 	0	 	No.
    of Outlets*1
	6-12	 	0.80	 	5	 	5+(No.
    of Outlets-5)*5/7
	13-33	 	0.60	 	10	 	10+(No.
    of Outlets-12)*10/21
	34-80	 	0.50	 	20	 	20+(No.
    of Outlets-33)*20/47
	81-150	 	0.40	 	40	 	40+(No.
    of Outlets-80)*20/70
	151-315	 	0.35	 	60	 	60+(No.
    of Outlets-150)*50/165
	316-565	 	0.30	 	110	 	110+(No.
    of Outlets-315)*60/250


 


	 	●	The
    piping system will be sized to limit pressure drop across the system to a maximum of 10% of the pressure regulator pressure.
	 	●	The
    compressed air equipment will be controlled by the stand alone main control panel and will be provided with a common trouble alarm
    that will be monitored and supervised by the building BAS system.


 


15.13.2.5
Nitrogen



 


	 	●	A
    liquid nitrogen tank and ambient vaporizer will be provided by a contracted vendor. The equipment will be located at the exterior
    of the building. The new tank and equipment will provide 7,000 scfh at 45 psig. Gaseous nitrogen service will be from the new liquid
    storage tank system. The liquid storage tank, vaporizer and associated components will be leased equipment.
	 	●	The
    nitrogen service to the facility will be fitted with duplex particulate filters each rated for 1 micron of filtration located at
    the exterior next to the ambient vaporizers. All piping will be sloped and trapped at low points for accumulation of condensation.
	 	●	The
    nitrogen system distribution pressure to all equipment and points of use shall be set to deliver pressures at 40 psig.
	 	●	Higher
    pressure nitrogen for the GPM area HPLC operation is provided from local gas cylinders and changeover manifolds provided by the owner.
	 	●	Nitrogen
    will be filtered through a final sterile filter rated for 0.2 micron removal rating. All point of use outlets and GMP area equipment
    will be fitted with point of use sterile filers.
	 	●	Piping
    will run above the first-floor ceiling and drop down to equipment locations along the wall, terminating at a quarter turn ball valve.
	 	●	Nitrogen
    piping will be ASTM B-819 Type “L” piping with brazed joints. Joints will be brazed (BcuP Series brazing) without flux,
    while being brazed all joints will be continuously purged with an inert gas to prevent the formation of scale.


 


www.protecsinc.com


 




    	51



     


    

 


 


	 	●	Type
    316L stainless steel piping with swage lock compression fitting will be provided within the GMP process areas.
	 	●	Valves
    will be 2 piece full port ball valves.
	 	●	All
    piping, fittings, valves, and accessories will be provided cleaned for oxygen service.
	 	●	A
    0.2 micron filter will be provided at each point of use.
	 	●	The
    nitrogen system will be designed to distribute low pressure nitrogen. Pressure will be reduced as necessary at points-of-use. The
    system will be sized based upon a load of 1 scfm per outlet and the total number of connected outlets connected to the system. Any
    point loads for specific equipment will be added to the outlet load after any diversity factors are applied. The diversity factors
    indicated below will be used for determining the load for outlets.


 


	Table
                                            2


Nitrogen
System Diversity Factors



	Number
                                            of

                                                                     Outlets
	 	Diversity

    Factor
	 	Minimum
                                            Flow

    (scfm)
	 	Empirical
                                            Formula for Flowrate

    (scfm)

	1-5	 	1.00	 	0	 	No.
    of Outlets*1
	6-12	 	0.80	 	5	 	5+(No.
    of Outlets-5)*5/7
	13-33	 	0.60	 	10	 	10+(No.
    of Outlets-12)*10/21
	34-80	 	0.50	 	20	 	20+(No.
    of Outlets-33)*20/47
	81-150	 	0.40	 	40	 	40+(No.
    of Outlets-80)*20/70
	151-315	 	0.35	 	60	 	60+(No.
    of Outlets-150)*50/165


 


	 	●	The
    piping system will be sized to limit pressure drop across the system to a maximum of 10% of the pressure regulator pressure.
	 	●	The
    nitrogen generation equipment will be monitored by the vendor for tank fill and tank pressure set points.


  


15.13.2.6
Natural Gas


 


	 	●	The
    existing natural gas service is supplied by PECO. The street main located in Souder Road fluctuates pressures between 25-99 psig.
    The street main has built in capability for all future needs in the area.
	 	●	The
    building existing incoming gas main is sized at 2 inches with pressures fluctuating between 25-99 psig.


 


www.protecsinc.com


 




    	52



     


     


 


	 	●	The
    building existing 2 inch gas main will remain in place and supply all building gas requirements for existing building needs and all
    new building expansions.
	 	●	The
    gas meter and main pressure regulator was replaced to handle the new building gas loads and capacities. The new pressure regulator
    was set to deliver 5 psig gas pressure to the building.
	 	●	The
    existing building pressure regulator located in the boiler room will remain as designed and pressures will be maintained to match
    the existing equipment requirements.
	 	●	The
    new expansion will be fitted with one main pressure regulator assembly that will reduce the incoming 5 psig gas pressure down to
    2 psig. The 2 psig gas main will be distributed to local pressure regulators throughout the building for gas pressure control to
    equipment.
	 	●	The
    emergency electrical generator will incorporate its own pressure regulator assembly located at the exterior of the building. The
    incoming 5 psig gas pressure will be reduced down to 14” wc. Exterior signage will be provided above the main shut-off valve
    for the gas supply to the emergency electrical generator.
	 	●	Natural
    gas will be distributed in schedule 40 black steel, Grade B piping with wrench operated plug valves. High-pressure piping (greater
    than 1/2 psig) and all piping 2-1/2” and larger will have butt- welded joints. Low pressure piping (1/2” psig or less)
    which is 2” and smaller and exposed to view, will have threaded joints. All concealed piping in walls or above ceiling will
    have butt-welded joints.
	 	●	All
    gas piping materials, components and installation will comply with NFPA 54 “National Fuel Gas Code”.


 


15.13.2.7
Vacuum


 


	 	●	A
    vacuum system will be provided to all laboratory and process areas as programmed.
	 	●	Two
    (2) 150 acfm @ 26” Hg vacuum pumps will be relocated to the new facility. The vacuum pumps will be tied together into a common
    header to service the expansion use requirements for Filling, C-800 and C-900.
	 	●	Piping
    will run above the ceiling and drop down to equipment locations along the wall, terminating at a quarter turn ball valve.
	 	●	Vacuum
    piping will be ASTM B-819 Type “L” piping with brazed joints. Joints will be brazed (BcuP Series brazing) without flux,
    while being brazed all joints will be continuously purged with an inert gas to prevent the formation of scale.


 


www.protecsinc.com 


 




    	53



     


    

 


 


	 	●	Type
    316L stainless steel piping with swage lock compression fitting will be provided within the GMP process areas.
	 	●	Valves
    will be 2 piece full port ball valves.
	 	●	All
    piping, fittings, valves, and accessories will be provided cleaned for oxygen service.
	 	●	Laboratory
    vacuum piping system will be sized based on 0.5 scfm per outlet plus any flow required for individual pieces of equipment. Diversity
    factors will be applied to laboratory outlets as indicated below.


 


	Table
                                            2

    Laboratory
    Vacuum System Diversity Factors

	Number
    of Outlets	 	Diversity
    Factor	 	Minimum
                                            Flow (scfm)
	 	Empirical
    Formula for Flowrate (scfm)
	1-5	 	1.00	 	0	 	No.
    of Inlets*0.5
	6-12	 	0.80	 	2.5	 	(5+(No.
    of Inlets-5)*5/7)*0.5
	13-33	 	0.60	 	5	 	(10+(No.
    of Inlets-12)*10/21)*0.5
	34-80	 	0.50	 	10	 	(20+(No.
    of Inlets-33)*20/47)*0.5
	81-150	 	0.40	 	20	 	(40+(No.
    of Inlets-80)*20/70)*0.5
	151-315	 	0.35	 	30	 	(60+(No.
    of Outlets-150)*50/165) *0.5
	316-565	 	0.30	 	55	 	(110+(No.
    of Outlets-315)*60/250) *0.5


 


	 	●	The
    piping system will be sized to limit pressure drop across the system to maximum of 5 inches of mercury vacuum. All piping will be
    sloped and trapped at low points for the accumulation of condensation.
	 	●	The
    laboratory vacuum system will not be designed to handle highly corrosive or hazardous applications.
	 	●	Minimum
    vacuum pressure to all use points is sized for 19” Hg.
	 	●	The
    vacuum system is designed and based on 50 scfm (252 acfm) at 19” at all equipment and outlet usage points with a pump inlet
    pressure of 26” Hg.


 


www.protecsinc.com 


 




    	54



     


    

 


 


15.13.2.8
RODI Lab Water System – See Division 17


 


	 	15.13	FIRE
    PROTECTION


 


	 	15.13.1	Introduction


 


The
project will require new fire protection systems to support the renovated area. The intent of this work is to provide a new sprinkler
system for the new building extension from the existing underground combined service main. The new areas will be fully sprinklered.


 


The
codes, standards, and regulations cited in Section 1 will be used and referred to for the design of this project.


 


The
balance of this section describes the approach for the project’s fire protection systems.


 


	 	15.13.2	Systems
    Description and Criteria


 


The
city water feeds into the mechanical room as an independent feed for fire water. The 8” line enters into the building and is distributed
to the facility. A new 6” branch line will be taken from the main to the expansion area. The design criteria will be a hydraulically
calculated automatic wet sprinkler system, ordinary hazard, with a density as determined by code for specific interior room areas and
applications as noted below.


 


Water
Flow Data Required (Available per HbO2 provided data)


 


Static
PSI = 66


Residual
PSI = 63


Flow
GPM = 1,280


 


Hazard
Occupancy and Design Criteria


 


Ordinary
Hazard # – Wet type sprinkler system


	 	●	0.15
    GPM per SF over most remote 1500 SF
	 	●	130
    SF max. head spacing


 


Lay-In/Hard
Ceilings:


 


White
concealed sprinkler head


135-170°F
temperature rating,


 


Lay-In/Hard
Ceilings: (Clean Areas):


 


White
sealed, concealed sprinkler head


135-170°F
temperature rating,


 


Exposed
Ceiling Areas:


 


Brass
Finish, Upright Sprinkler Head 135-170°F Temperature Rating,


 


Warehouse
Area:


 


Empty
pallets are not allowed to be stored in racks and solid piled wood pallets are not permitted to be stored more than 8 ft. high.


 


An
Early Suppression Fast Response (ESFR) type sprinklers or in-rack sprinklers are not required. Materials will not be stored higher than
12’-0” above finished floor.


 


Wet
pipe sprinkler piping will be schedule 40 black steel with cut grooved couplings or schedule 10 with roll grooved couplings in sizes
2” and larger and threaded joints and fittings in sizes 1 1⁄2” and smaller.


 


www.protecsinc.com


 




    	55



     


    

 


 


	 	16.0	Electrical


 


	 	16.1	Introduction


 


The
proposed expansion will require an extension from the existing electrical service at the facility to power the expansion. An owner furnished
backup generator will be installed and a new UPS will be provided for backup power to specific equipment and systems.


 


A
description of the systems follows:


 


	 	16.2	Electrical
    Service


 


The
existing building electrical service will be will be upgraded to support the expansion. The existing pad mount transformer will be replaced
by PPL and a new termination cabinet will be provided to re-feed the existing switchgear and feed the new switchgear required for the
project.


 


	 	16.3	Power
    Distribution


 


All
mechanical system motors, where possible, will be operated at 480Volt/3- Phase. All process system motors, where possible, will be operated
at 480Volt/3- Phase. Some mixers and other process systems are rated for 355V at 50hz. VFDs will be programmed to convert the frequency
and voltage to run the motors properly on 480V/60hz house power. The VFDs serving all process equipment shall be equipped with Modbus
TCO interface modules with communication wiring to skid and automation control panels as required. All motors will either be fed from
either individual starters or variable frequency drives (VFD). These starters and VFDs will be fed from the 480V distribution power panels
located in the second floor platform space. In general, the motor controllers will be NEMA- Rated, combination-starter type, with motor
circuit protectors and solid- state (electronic) overload protection. Each skid panel will have a Hand-Off-Automatic (HOA) switch, green
“run” pilot light, and control power transformer with 100% spare capacity. A minimum of two normally open and two normally
closed auxiliary contacts will be provided with each starter. Other auxiliary contacts for miscellaneous controls will be provided as
required. VFDs serving equipment in the process areas will be located on the catwalk or upper level corridor.


 


480V
distribution panels will be installed to serve HVAC and process equipment and miscellaneous process receptacle and lighting panels at
208Y/120V. These receptacles panels will be fed via step-down transformers.


 


All
lighting fixtures will be powered at 277V. New 480Y/277V lighting panels will be installed throughout the facility to distribute power
to the lighting fixtures. These lighting panels will be fed from 480 Volt distribution panels located within the areas they serve.


 


www.protecsinc.com 


 




    	56



     


    

 


 


208Y/120V
receptacle panels will be installed throughout the facility as required to feed receptacle devices and miscellaneous equipment requiring
208 or 120 Volts. These panels will be fed from appropriately sized step-down transformers.


 


All
panels will be designed to be full-rated for short circuit protection. Buses and wiring shall be designed with copper as the basis of
design.


 


Panel
and ATS short circuit ratings shall be confirmed by the required Short Circuit Studies, life safety breaker coordination shall be confirmed
by the required Coordination Studies, and new equipment warning labels shall be confirmed by the required Arc Flash Studies.


 


All
step-down transformers will be specified to have a 150° C temperature rise over a 40° C ambient and a 220° C insulation system.


 


	 	16.4	Emergency
    Power


 


An
owner furnished outdoor 625 kW, 480 Volt natural gas back up generator will be installed to provide back-up emergency power. The generator
will be located on the roof. The emergency generator will be designed in accordance with NFPA 110. Emergency power will be distributed
to a new life safety automatic transfer switch (ATS) and to the existing ATS which will be re-designated as a legally required &
optional standby ATS. Both switches will be located in the interstitial space of the existing facility. Life safety loads will be redistributed
to segregated life safety power distribution via new EM1 and EL1 panels adjacent to the new life safety ATS.


 


Miscellaneous
480 Volt and 208Y/120 Volt emergency power and receptacle panels will be installed throughout the facility to distribute emergency power.
In addition, 480Y/277V emergency lighting panels will be installed to feed emergency lighting at 277V.


 


The
generator will serve the following loads:


 


Life
Safety:


 


	 	●	Emergency
    lighting and exit signs
	 	●	Access
    control system
	 	●	Fire
    alarm system


 


Legally
Required & Option Standby:


 


	 	●	Existing
    Souderton Facility Back-up EMCC equipment


 


www.protecsinc.com


 




    	57



     


    

 


 


	 	●	Filling
    Area HVAC
	 	●	Building
    Automation System (BAS)
	 	●	Process
    Automation System
	 	●	C-800
    Process Equipment – Excluding Chillers (See Process Equipment Matrix)
	 	●	C-900
    Process Equipment – Excluding Chillers (See Process Equipment Matrix)
	 	●	Buffer
    Prep Process Equipment (See Process Equipment Matrix)
	 	●	Filling
    Equipment (See Process Equipment Matrix)
	 	●	Filling
    Equipment RABS (See Process Equipment Matrix)
	 	●	Process
    Equipment Utilities (See Process Equipment Matrix)
	 	●	Waste
    Neutralization System
	 	●	CFR
    21 Part 11 Compliant Monitoring System
	 	●	Relocated
    Walk in Refrigerator
	 	●	New
    Walk in Refrigerator
	 	●	Chemical
    Room Exhaust Fan
	 	●	Chemical
    Room HVAC
	 	●	Uninterruptible
    power supply system
	 	●	Security
    system
	 	●	Freezer,
    Lab #105
	 	●	Refrigerators
    (1), Lab #105
	 	●	Incubators
    (2), Lab #105
	 	●	Biosafety
    Hood (1), Lab #119
	 	●	QC
    Refrigerator (2), Lab #121
	 	●	QC
    Freezer (1), Lab #121
	 	●	Low
    Temperature Refrigerator (1), Lab #121
	 	●	Refrigerator
    (Samples & Glute) (1), Rm. #169
	 	●	Weigh
    Roof Dispensing Exhaust Fan (EF-9)
	 	●	4’
    Fume Hood & Associated Exhaust Fan (1), Rm. #171
	 	●	Fumehood
    Pump (1), Rm. #171
	 	●	Server
    Equipment (120V, 20A Circuit), Rm. #214


 


A
remote shut-off pushbutton will be located in the electrical switchgear room. A remote generator annunciator panel will be installed
at central control room.


 


An
additional automatic transfer switch (ATS) will be added for standby equipment and located in the new electrical room 161C for proximity
to equipment in the new addition which require generator backup.


 


www.protecsinc.com


 




    	58



     


    

 


 


	 	16.5	Uninterruptible
    Power Supply


 


A
rack-mounted sealed battery 30 KW UPS system, will be provided to support specific critical equipment and systems. The existing UPS will
continue to serve loads in C-500 and as originally connected. 15 minutes of runtime will be provided.


 


The
UPS will serve the following loads:


 


	 	●	Process
    Automation System
	 	●	Building
    Automation System (BAS)
	 	●	Access
    Control System
	 	●	CFR
    21 Part 11 Compliant Monitoring System
	 	●	Security
    System
	 	●	Server
    Equipment (120V, 20A Circuit in Servers Room 214)


 


	 	16.6	Surge
    Suppression Device


 


A
surge protection device will not be required for this project – considered in main building gear by others.


 


	 	16.7	Lighting


 


Light
fixtures and lighting levels throughout the building will be as follows:


 


	AREA	 	FIXTURE
    TYPE LAMP/LENS	 	FOOTCANDLE
                                            LEVEL (At Task)

	Corridors	 	Fluorescent/Parabolic	 	30-40
	Office	 	Fluorescent/Prismatic	 	40-50
	Laboratories	 	Fluorescent/Prismatic	 	50-60
	Cleanrooms	 	Fluorescent/Wet	 	50-60
	Mechanical
    Spaces	 	Fluorescent/Industrial	 	30-40
	Electrical
    Rooms	 	Fluorescent/Industrial	 	40-45
	Warehouse	 	Fluorescent
    or LED / Aisle
    Lighter	 	30-40


 


Standard
fluorescent troffers with parabolic lenses will be installed in the office, conference rooms, and office support areas. Fluorescent troffers
with prismatic lenses will be provided in lockers rooms, lab spaces, and lab support areas. Chain- hung 1’x4’ industrial
fixtures with 10-15% uplight component will be installed in utility areas, mechanical spaces, electrical rooms and the maintenance shop.
All fluorescent fixtures will be provided with energy-saving 28 watt T-5 and 24W T5HO, 3500K lamps and electronic ballasts.


 


www.protecsinc.com 


 




    	59



     


    

 


 


Triple
gasketed cleanroom type fixtures with powder coated or stainless steel frames will be installed in the cleanroom suites, airlocks, and
corridors to maintain air pressurization and cleanliness.


 


Pendant
mounted high-bay aisle lighter type fixtures will be provided throughout the warehouse to allow for adequate lighting levels on the vertical
surfaces. Low- bay fixtures will be installed in the shipping and receiving loading dock areas.


 


New
low wattage LED type exit signs will be installed throughout the new building extension as required by local and national codes.


 


Wall
toggle switches will be installed for control of lighting in process areas. Wall or ceiling occupancy sensors will be installed to control
lighting in areas other than process areas. Certain fixtures within the facility will connect to the emergency generator and serve as
emergency lighting in the event of a power failure. These fixtures will be controlled from circuit breakers in the emergency lighting
panels from where they are fed. These fixtures will serve as night lighting for the facility. Circuit breakers controlling fixtures will
be switching duty rated breakers. Light switches in lab areas will be specified with gasketed covers to protect against moisture during
cleaning.


 


	 	16.8	Site
    Lighting


 


Site
lighting is existing to remain. Two new pole lights for the parking lot expansion will be provided as part of the building shell construction
project.


 


	 	16.9	Receptacles


 


Convenience
receptacles will be provided throughout the facility such that the distance to a receptacle from any location in the building will be
no more than 50 feet.


 


Rectangular
shaped offices will be provided with a duplex receptacle on at least three walls. The receptacle on the wall near the office occupant’s
desk will be a quadraplex receptacle (double duplex) to provide outlets for computer equipment as well as miscellaneous office equipment
such as pencil sharpeners, task lights, etc.


 


Special
receptacles at 208V, 230V or 480 V will be provided to serve specific equipment requiring voltages other than 120V. All receptacle devices
located in process rooms will be provided with neoprene gasketing and weatherproof coverplates to maintain cleanliness and air pressurization
while protecting against moisture during cleaning. All receptacles in all lab areas are to be GFI protected.


 


www.protecsinc.com 


 




    	60



     


    

 


 


The
labs will be provided with a pre-wired, surface mounted, dual channel, raceway or wiremold system. This system will contain both receptacle
and tele/data devices segregated by means of a divider. Tele/data wiring and devices will be provided as noted in the Telecommunications
discussion below. Spacing of receptacle and tele/data devices will be determined based upon the layout and utility requirements of the
laboratory equipment. All 120V receptacles in the lab area and where within 6’-0” of a sink will be ground-fault interrupter
type receptacles.


 


	 	16.10	Basic
    Materials and Methods


 


In
general, raceways will be as follows:


 


Outdoors


 


	 	1.	Feeders
    (exposed) – Rigid Galvanized Steel.
	 	2.	Feeders
    (concealed) – Rigid Galvanized Steel.
	 	3.	Connections
    to motors and vibrating equipment – Liquid Tight flexible metal conduit.
	 	4.	Concrete
    encased – Schedule 40 PVC rigid non-metallic conduit.
	 	5.	Boxes
    and enclosures – NEMA 3R. 


 


Indoors


 


	 	1.	Feeders
    & branch circuits (exposed outside of CNC and ISO classified spaces) – Electrical Metallic Tubing (EMT).
	 	2.	Feeders
    & branch circuits (exposed in CNC and ISO classified spaces) – PVC coated EMT and LFMC.
	 	3.	Feeders
    (damp or wet locations) – Rigid Galvanized Steel.
	 	4.	Lighting
    and receptacle branch circuits – Electrical Metallic Tubing.
	 	5.	Exposed
    conduits in lab rooms –Rigid Galvanized Steel.
	 	6.	Connections
    to motors and vibrating equipment – Flexible metal conduit in dry area and liquid tight flexible metal conduit in wet areas.
	 	7.	MC
    cable or flexible metal conduit to overcome building obstructions and between junction boxes and lighting fixtures with a maximum
    of 6 foot length. MC cable will also be used for receptacle branch circuits in hollow stud partitions except for homeruns and room
    interconnection runs, which will be run in EMT.
	 	8.	Boxes
    and enclosures – NEMA 1 in dry area and NEMA 4 in damp or wet areas.
	 	9.	Boxes
    and enclosures – NEMA 3R in CNC and ISO classified spaces.
	 	10.	Hazardous
    Locations – Rigid Galvanized Steel.


 


www.protecsinc.com 


 




    	61



     


    

 


 


	 	11.	Sealed
    fittings will be provided for all conduits penetrating into hazardous locations.


 


	 	16.11	Grounding


 


The
existing grounding system for the building will remain as-is. All new equipment will be grounded in accordance with the National Electric
Code (NEC) Article 250. Included in the project cost are separate equipment grounding conductors which will be sized and installed in
all raceways in accordance with the NEC.


 


Grounding
requirements are to be determined pending the hydrogen generation calculation and evaluation.


 


	 	16.12	Lightning
    Protection System


 


New
roof top equipment will be connected to the existing lightning protection system. Existing system to be recertified at construction completion
to current level.


 


	 	16.13	Fire
    Alarm System


 


The
existing building fire alarm system has been upgraded to a new fire alarm system as part of the building shell construction project which
has been confirmed to have adequate capacity for quantity of new devices. Devices will be provided as required by applicable national
and local codes. As a minimum, the system will consist of the following:


 


	 	a.	Manual
    pull stations will be located at each exit from the facility and at exits from others floors of the building. Pull stations will
    be located with a maximum travel distance of 200 feet between stations.
	 	b.	Combination
    horn-strobes and strobes will be located in the corridors, toilet rooms and common spaces. Horn-strobes will also be located in all
    Process and Manufacturing Rooms.
	 	c.	Ionization-type
    duct smoke detectors will be located as required for supply and return fans. The duct detectors will be hard wired to their corresponding
    fan motor starters or VFDs and to the fire alarm main control panel.
	 	d.	Smoke
    detectors will be provided in electrical rooms, mechanical rooms, warehouse, storage areas, tele/data closets, and on equipment platforms.
	 	e.	A
    fire alarm annunciator panel will be located in the lobby.
	 	f.	Fire
    Alarm extender panels will be provided as required.


 


The
fire alarm system will be interfaced with the security and access control systems to release all egress doors in the event of a building
alarm. In addition, the fire alarm system will interface with the building automation system.


 


www.protecsinc.com


 




    	62



     


    

 


 


The
electrical contractor will provide back boxes with empty conduit and pull wire to above nearest accessible ceiling. The fire alarm vendor
will furnish, install, and wire all new fire alarm devices.


 


	 	16.14	Security
    System


 


By
HbO2.


 


	 	16.15	Telecommunications


 


The
telephone and data scope of work will be completed by HbO2. Conduit drops with pull strings and boxes at use points will be provided
by PROTECS.


 


Tele/Data
drops required for systems installed by PROTECS will be identified for installation by HbO2’s tele/data subcontractor.


 


	 	16.16	Public
    Address System


 


Not
applicable


 


	 	16.17	Access
    Control (Pressurization)


 


The
airlock doors within the cleanroom area will be interlocked to allow for only one door to be open at a time within a given airlock.


 


The
existing card reader system will be expanded to include new exterior doors and specific interior doors for access control.


 


Mag
Locks or electrified hardware will be used for interlocking and card access.


 


www.protecsinc.com 


 




    	63



     


    

 


 


	 	17.0	PROCESS


 


	 	17.1	EXECUTIVE
    SUMMARY


 


Hemoglobin
Oxygen (HbO2) Therapeutics is expanding its existing Souderton, PA facility to incorporate the C-800 and C-900 processes being relocated
from the Cambridge, MA facility and the aseptic filling operations that were previously performed in Canada.


 


Manufactured
products are hemoglobin based oxygen carrying solutions, Hemopure (intended for human use) and Oxyglobin (intended for veterinary use).
The renovated Souderton, PA facility is designed to perform separation, purification and polymerization of a hemoglobin based oxygen
carrying solution and aseptic filling and packaging. The Souderton, PA facility was previously designed to perform the first step of
the manufacturing process, the separation of source material into a stable intermediate (C-500). A previously existing Cambridge, MA
facility was designed to perform the final two steps of the manufacturing process, the purification of the cell free hemoglobin to a
purified deoxygenated hemoglobin (C-800) and the polymerization of purified hemoglobin to the final product (C-900). The C-800 and C-900
processes occurring at the Cambridge, MA facility will be relocated to the Souderton, PA expansion area. In addition, new aseptic filling
and packaging process previously performed by a CMO will be added to the Souderton, PA expansion area under a Restricted Area Barrier
System (RABS).


 


The
purpose of this section is to detail the process operations which will take place in the Souderton, PA facility expansion and the process
and clean utility equipment that will be installed to support the new intended operation of the facility.


 


The
facility is designed to meet the requirements of North American and European regulatory requirements.


 




    	64



     


    

 


 


	 	17.2	PROCESS


 


	 	17.2.1	General


 


The
Souderton, PA facility currently designed to complete the initial C-500 process will be expanded to incorporate the final C-800 and C-900
processes previously executed in the Cambridge, MA facility. In addition, aseptic filling and packaging operations will be added to the
facility.


 


	 	17.2.2	Product
    Description


 


There
are two drug products that are derived from the source material:


 


	 	●	Hemopure
    (intended for human use)
	 	●	Oxyglobin
    (intended for veterinary use)


 


Hemopure
is a hemoglobin based oxygen carrying solutions used as an alternative to blood transfusions for surgical anemic patients and compassionate
use. Oxyglobin is the veterinary equivalent to Hemopure. The difference between the two solutions is the additional step of removing
the low molecular weight fraction after polymerization required for the Hemopure product. The products will be packaged in sterile IV
bags for injection.


 


The
products are planned to serve the European and US markets. Therefore, the facility will require compliance with current Good Manufacturing
Practices in North America and Europe.


 


	 	17.2.3	Plant
    capacity


 


The
facility will be designed for the production of 50,000 units of Hemopure per year (200,000 units of Oxyglobin). The design is based on
the following assumptions:


 


	Table
    1:	 	Oxyglobin	 	Hemopure	 	 
	Available
    weeks:	 	46	 	46	 	Weeks
    / year
	Work
    hours per day (2 x 12 hr shift):	 	24	 	24	 	Hours
    / day
	Work
    days per week:	 	7	 	7	 	Days
    / week
	Batch
    working volume (up to):	 	769	 	384	 	L
	Unit
    volume:	 	0.125	 	0.250	 	L
	Number
    of units (up to):	 	5226	 	1307	 	Units
    / batch


 


The
C500 stage of the process produces a 1300L batch of C500 intermediate product. The C800 stage of the process produces an 1100L batch
of C800 intermediate product. This volume of C800 intermediate product is then split into three sub-batches for the C900 stage of the
process which produces a final batch volume of up to 769L of Oxyglobin or 384L of Hemopure product. The chromatography phase of the C800
process was determined to be the rate limiting operation taking a total of 5 days to complete.


 


www.protecsinc.com 


 




    	65



     


    

 


 


	 	17.2.4	Manufacturing


 


The
manufacturing of the hemoglobin based oxygen carrying solution products consist of the following main procedures:


 


	 	●	Blood
    Collection
	 	●	Separation
    (C-500)
	 	●	Purification
    (C-800)
	 	●	Polymerization
    (C-900)
	 	●	Aseptic
    Filling / Packaging 


 


Additional
supporting procedures include:


 


	 	●	Component
    / equipment washing, preparation and sterilization.


 


	 	17.2.4.1	Blood
    Collection


 


Bovine
whole blood (i.e. the raw material) is collected from a large volume abattoir. The whole blood arrives at the facility in individual
pre-sanitized semi- closed, 20L single use bags. The collection bags are pre-dosed with sodium citrate solution, an anti-coagulant, at
the Souderton, PA facility. The filled bags are placed on ice during transport to the facility.


 


	 	17.2.4.2	Separation
    (C-500)


 


The
C-500 separation area receives source material and converts it to a stable intermediate (C-500). There are three unit operations taking
place within the separation area which are all conducted in closed systems.


 


The
three unit operations are:


 


	 	●	Cell
    Wash
	 	●	Separation
	 	●	Ultrafiltration


 


During
transfer from the single use bags to the cell wash tank, macro-contaminants are removed by pumping citrated bovine blood through a 50
μ strainer and 60 μ depth filter. During the cell washing step, plasma proteins are removed and the solution is recirculated
across a 0.45 μ hollow fiber filter while saline is continuously added.


 


Washed
cells are then pumped into a separation centrifuge spinning at approximately 13,500 x G which separates the heavy phase containing red
blood cells from the light phase containing the white blood cells. Mechanical lysing of the red blood cells occurs while the cells are
discharged from the separator and strike the wall of the collection pan.


 


The
heavy phase is then transferred to the ultrafiltration system to remove cell wall debris and micro contaminants falling outside the range
of 100,000D molecular weight cut-off (MWCO) to 30,000D MWCO. Ultrafiltration occurs in two phases.


 


www.protecsinc.com


 




    	66



     


    

 


 


Phase
I uses diafiltration with purified water across 100 kD hallow fiber filters. Phase II of ultrafiltration uses recirculation across a
30 kD filter.


 


C-500
is pumped through a 0.50 μ pre-filter and 0.20 μ final filter to either a hold tank or sterilized, single use bulk bags.
In bags, C-500 is held in cold storage (2- 10oC) for up to 28 days. In jacketed hold tank, C-500 is kept at 2-10 oC until ready
to transfer to purification.


 


	 	17.2.4.3	Purification (C-800)




 


The
C-800 purification area receives the cell-free hemoglobin intermediate (C- 500) and converts it to purified deoxygenated hemoglobin (C-800).
There are four processes taking place within the purification area.


 


The
four processes are:


 


	 	●	High
    Performance Liquid Chromatography (HPLC)
	 	●	Concentration
	 	●	Deoxygenation
	 	●	Diafiltration


 


The
C-500 is received and transferred to the chromatography feed tank to initiate the purification process by HPLC. The chromatographic cycle
consists of injecting the hemoglobin onto the column, developing a pH gradient, collecting the product, column wash, and column re-equilibration
with load buffer. The pH gradient is made by mixing two buffers (Buffer A and Buffer B) to decrease the pH of the columns to rid of unbound
and loosely bound non-hemoglobin components. The pH is reduced again to release the hemoglobin that is then diverted to a concentration
tank. A high salt buffer (Buffer C) is used to elute tightly bound non- hemoglobin components. The columns are then flushed with a high
pH buffer (Buffer A) to re-equilibrate for another injection.


 


The
purified hemoglobin from the chromatography columns is collected in the concentration tank where it is continuously concentrated using
a 30,000D MWCO ultrafilter. The concentrated hemoglobin is then pumped to a deoxygenation tank where the hemoglobin solution is deoxygenated
by recirculating it past a 0.05 μ phase transfer membrane. Filtered nitrogen gas is passed on the opposite side of the membrane
in a counter-current direction to strip the oxygen out of the hemoglobin solution.


 


The
deoxygenated, concentrated hemoglobin solution is then stabilized through diafiltration. The solution is exchanged with three volumes
of deoxygenated Compound-800 Storage Solution by recirculating it across a 30,000D MWCO ultrafilter in diafiltration mode.


 


The
final deoxygenated hemoglobin product (C-800) is transferred through a 1 μ pre-filter and a 0.20 μ filter before collecting
in one of two sanitized, agitated C-800 batch holding tanks. These nitrogen blanketed tanks hold the C-800 product at 17-22o until
ready for transfer to polymerization.


 


www.protecsinc.com 


 




    	67



     


    

 


 


	 	17.2.4.4	Polymerization
    (C-900)


 


The
C-900 polymerization area receives purified hemoglobin (C-800) and converts it to the final product (C-900). There are four processes
taking place within the polymerization area.


 


The
four processes are:


 


	 	●	Activation
    (polymerization)
	 	●	Stabilization
	 	●	Equilibration
	 	●	Fractionation
    (Hemopure only)


 


Deoxygenated
hemoglobin is polymerized with the addition of glutaraldehyde. The reaction conditions are carefully controlled. They include glutaraldehyde
addition rate, solution temperature, and mixing rate.


 


The
polymerized hemoglobin is concentrated and diafiltered with borate buffer to adjust the pH by recirculation through 30,000D MCWO ultrafilters.
The reaction products are stabilized with the addition of sodium borohydride.


 


During
the addition of sodium borohydride, the polymerized hemoglobin solution is recirculated across a phase transfer membrane to minimize
levels of hydrogen gas and maintain the deoxygenated state. It is then concentrated and diafiltered with Diafiltration Solution A to
achieve equilibration.


 


To
produce Hemopure, the polymerized product is then transferred to the fractionation tank where the low molecular weight fraction is removed
using a 70,000D MWCO ultrafiltration process by diafiltration with Diafiltration Solution C. This product is then concentrated with a
30,000D MCWO ultrafilter.


 


The
polymerized hemoglobin solution is then transferred through a series of three filters: a 0.50 μ pre-filter, a 0.20 μ sterile
filter, and a 0.10 μ final sterile filter before collecting into sterilized pooling tanks held under a nitrogen blanket at 15-
30o.


 


	 	17.2.4.5	Filling
    / Packaging


 


The
product is kept in the pooling tanks for up to 10 days or until release testing results are obtained. The product is then The filling
will be done under ISO class 5 Restricted Access Barrier Space (RABS), located in a ISO class 7 background. The final fill process consists
of the semi-automated filling equipment which was used to fill the I.V. bags at the previous contract manufacturer’s site. An operator
is required to load the empty IV bags. The automated filling equipment prints the batch number, opens sterile I.V. bags, vacuums the
inside of the empty I.V. bag, fills it with a pre- set dose of product, permanently seals the bags, cuts the piece above the weld, and
unloads the I.V. bags. I.V bags are two different sizes: 250mL and 500mL, with fill targets of 60mL, 125mL, 250mL. Filling line is cleaned
in place and sterilized in place (CIP/SIP)


 


www.protecsinc.com 


 




    	68



     


    

 


 


After
filling the product is transferred out of the filling room to the labeling and overwrap room where the product is inspected including
leak testing, seal integrity testing and weight checks. The product is next labeled and then inserted into clear overwrap pouches, purged
with nitrogen and sealed under a vacuum. A checkweigher will be used to verify the weights of filled I.V. bags throughout the filling
operation (samples only - IPC). The product is then inspected including leak testing, seal integrity testing and weight checks before
transferring to product storage. Once an order if filled the product is removed from storage, individually boxed, labeled, crated and
transferred to the warehouse for shipping.


 


The
filling process including set up, product fill and cleaning will be targeted to a one-week duration. Maximum fill time will be based
on product. Target fill time will be up to 12 hours over the span of two shifts.


 


	 	17.2.4.6	Component
    / equipment washing, preparation and sterilization


 


A
new cGMP autoclave and clean parts wash room are required to support the filling operation.


 


	 	17.2.5	Process
    equipment


 


	 	17.2.5.1	Separation
    (C-500)


 


	 	17.2.5.1.1	Citrate
    Buffer


 


The
citrate buffer equipment consists of an agitated 300 L tank (T-150) to pre-fill 20L single use bags with sodium citrate solution (anticoagulant)
for bovine whole blood collection and transfer.


 


This
system is pre-existing and will not be modified.


 


	 	17.2.5.1.2	Saline
    Buffer


 


The
saline buffer equipment consists of an agitated 4000 L make-up tank (T-170) and 2500 L loop tank (T-171) used to infuse saline solution
into cell wash steps during recirculation across cell wash filters.


 


This
system is pre-existing and will not be modified.


 


	 	17.2.5.1.3	Cell
    Wash


 


The
cell wash equipment consists of an agitated 1200 L cell wash tank (T- 201) used to remove macro-contaminants and plasma proteins.


 


This
system is pre-existing and will not be modified.


 


www.protecsinc.com


 




    	69



     


    

 


 


	 	17.2.5.1.4	Separation


 


The
separation equipment consists of a Separation Centrifuge (CT-301) used separate the heavy phase containing red blood cells from the light
phase containing white blood cells.


 


This
system is pre-existing and will not be modified.


 


	 	17.2.5.1.5	Stage
    1 Ultrafiltration


 


The
stage 1 ultrafiltration equipment consists of a 900 L Stage 1 Ultrafiltration tank (T-510) which uses diafiltration across a 100 kD filter.


 


This
system is pre-existing and will not be modified.


 


	 	17.2.5.1.6	Stage
    2 Ultrafiltration


 


The
stage 2 ultrafiltration equipment consists of a 2000 L Stage 2 Ultrafiltration tank (T-511) which recirculates across a 30 kD filter.


 


This
system is pre-existing and will not be modified.


 


	 	17.2.5.2	Purification
    (C-800)


 


	 	17.2.5.2.1	Radial
    Chromatography


 


The
radial chromatography equipment consists of a nitrogen blanketed 1400 L feed tank (T-601) to an eight column High Performance Liquid
Chromatography (HPLC) system using radial compression chromatographic media columns containing silica-based anion media.


 


This
system is a pre-existing system being relocated. The feed tank, along with a vent filter and nitrogen filter, will be repurposed from
an existing tank (T-806C). A new agitator will be added to the feed tank.


 


The
new agitator will have the following characteristics:


 


	 	●	Stainless
    steel 316L, surface finish of 20Ra μin
	 	●	Variable
    Speed
	 	●	Bottom
    Mounted Mag Drive


 


	 	17.2.5.2.2	Buffer
    Prep and Distribution


 


The
buffer prep equipment consists of four agitated 1500 L make-up tanks (T-610, T-620A, T-620B, and T-640), a 1200 L make-up tank (T-650),
two 1500 L loop tanks (T-611 ad T-621), a 1400 L loop tank (T-651), a new 1500 L loop tank (T-641) and an agitated 1500 L C-800 storage
buffer make-up tank (T-630) to be used throughout the purification process.


 


This
system is a pre-existing system being relocated. The new 1500L loop tank (T-641) will replace the previously existing 1100L loop tank
and be modeled after the additional 1500L buffer loop tanks (T-611 and T-621).


 


www.protecsinc.com


 




    	70



     


    

 


 


The
new Buffer C Loop Tank will have the following characteristics:


 


	 	●	Stainless
    steel 316L, internal surface finish of 20Ra μin and Electropolished (BPE SF-4)
	 	●	Working
    volume: 1500 L
	 	●	Design
    pressure: 50 PSIG & F.V.
	 	●	Chilled
    water jacket
	 	●	Top
    connections:





 





	 	○	Manhole
	 	○	Product
    inlet port
	 	○	Vent
    filter
	 	○	Sprayball


 





	 	●	Bottom
    connections:


 








	 	○	Product
    outlet


 


	 	17.2.5.2.3	Concentration


 


The
concentration equipment consists of a 500 L concentration tank (T- 801) continuously recirculating product across a 30 kD filter.


 


This
system is a pre-existing system being relocated and will not be modified.


 


	 	17.2.5.2.4	Deoxygenation
    and Diafiltration


 


The
deoxygenation and diafiltration equipment consists of an agitated 500 L* deoxygenation tank (T-805) uses a 0.05 μ phase transfer
membrane with nitrogen passes on the opposite side in a countercurrent direction for deoxygenation and uses a 30 kD filter in diafiltration
mode to exchanges three volumes of C-800 storage solution for stabilization.


 


This
system is a pre-existing system being relocated. The deoxygenation tank will be repurposed from an existing tank (previously T-601).
A new agitator will be added to the deoxygenation tank.


 


The
new agitator will have the following characteristics:


 


	 	●	Stainless
    steel 316L, surface finish of 20Ra μin
	 	●	Variable
    Speed
	 	●	Bottom
    Mounted Mag Drive


 


	 	17.2.5.2.5	Batching
    Tanks


 


The
batching tank equipment consists of two agitated 1400 L batch tanks (T-806A and T-806B) maintaining C-800 product at a temperature of
17- 22oC under a nitrogen blanket until ready for polymerization.


 


This
system is a pre-existing system being relocated. A new agitator will be added to each batch tank.


 


www.protecsinc.com 


 




    	71



     


    
 


 


	 	 	The
    new agitators will have the following characteristics:
	 	 	 	 
	 	 	●	Stainless
    steel 316L, surface finish of 20Ra μin
	 	 	 	 
	 	17.2.5.3	Polymerization
    (C-900)
	 	 
	 	 	17.2.5.3.1
    DeOxy WFI and Borate
	 	 	 
	 	 	The
    deoxy WFI and borate equipment consists of an agitated 2000 L make-up tank (T-960) used during polymerization for stabilization.
    
	 	 	This
    system is a pre-existing system being relocated and will not be modified.
	 	 	 
	 	 	17.2.5.3.2
    DFA and DFC
	 	 	 
	 	 	The
    DFA and DFC equipment consists of three agitated 2000 L make-up tanks (T-970, T-980A and T-980B) and two 2000L loop tanks (T-971
    and T-981) used during polymerization for equilibration and fractionation. 
	 	 	 
	 	 	This
    system is a pre-existing system being relocated and will not be modified.
	 	 	 
	 	 	17.2.5.3.3
    Polymerization Reactor
	 	 	 
	 	 	The
    polymerization reactor equipment consists of a double agitated 1100 L reactor (R-952) which recirculates through a 30 kD polymerization
    filter and a 0.05 μ phase transfer membrane with nitrogen. 
	 	 	 
	 	 	This
    system is a pre-existing system being relocated. The reactor, including the two agitators, will be new. 
	 	 	The
    new reactor will have the following characteristics:
	 	 	 
	 	 	 	●	Stainless
    steel 316L, internal surface finish of 15Ra μin and Electropolished (BPE SF-4)
	 	 	 	●	Working
    volume: 1100 L
	 	 	 	●	Design
    pressure: 60 PSIG & F.V.
	 	 	 	●	Chilled
    water and warm water jacket
	 	 	 	●	Top
    connections:
	 	 	 	 	○	Product
    transfer port
	 	 	 	 	○	Vent
    filter
	 	 	 	 	○	N2
    filter
	 	 	 	 	○	Connection
    for agitator
	 	 	 	 	○	Cleaning
    machine
	 	 	 	●	Bottom
    connections:
	 	 	 	 	○	Product
    outlet
	 	 	 	 	○	Connection
    for agitator


 


www.protecsinc.com


 




    	72



     


    

 


 


	 	 	●	Top
    Agitator
	 	 	 	○	Stainless
    steel 316L, surface finish of 15Ra μin and Electropolished (BPE SF-4)
	 	 	 	○	Top
    mounted
	 	 	 	○	Large
    diameter impeller
	 	 	 	○	Slow
    speed
	 	 	●	Bottom
    Agitator
	 	 	 	○	Stainless
    steel 316L, surface finish of 15Ra μin and Electropolished (BPE SF-4)
	 	 	 	○	Bottom
    mounted
	 	 	 	○	Mag
    Drive


 


	 	 	17.2.5.3.4
    Reactor Activation, Deactivation and Neutralization
	 	 	 
	 	 	The
    reactor activation, deactivation and neutralization equipment consists of an agitated 300 L activation tank (T-951), an agitated
    150 L quench tank (T-953) and a 300L Off Gas Tank used during polymerization for activation and neutralization.
	 	 	 
	 	 	This
    system is a pre-existing system being relocated. All three tanks will be purchased new.
	 	 	 
	 	 	The
    new activation tank will have the following characteristics:


 


	 	●	Stainless
    steel 316L, internal surface finish of 15Ra μin and Electropolished (BPE SF-4)
	 	●	Working
    volume: 300 L
	 	●	Design
    pressure: 50 PSIG & F.V.
	 	●	Chilled
    water jacket
	 	●	Top
    connections:
	 	 	○	Manhole
	 	 	○	DeOxy
    WFI port
	 	 	○	Vent
    filter
	 	 	○	N2
    filter
	 	 	○	Sprayball
	 	●	Bottom
    connections:
	 	 	○	Product
    outlet
	 	 	○	Connection
    for agitator
	 	●	Agitator
	 	 	○	Stainless
    steel 316L, surface finish of 15Ra and Electropolished (BPE SF-4)
	 	 	○	Bottom
    mounted
	 	 	○	VS


 


www.protecsinc.com


 




    	73



     


    

 


 


	 	The
    new quench solution tank will have the following characteristics:
	 	 
	 	 	●	Stainless
    steel 316L, internal surface finish of 15Ra μin and Electropolished (BPE SF-4)
	 	 	●	Working
    volume: 150 L
	 	 	●	Design
    pressure: 50 PSIG & F.V.
	 	 	●	Top
    connections:
	 	 	 	○	Manhole
	 	 	 	○	DeOxy
    WFI port
	 	 	 	○	Vent
    filter
	 	 	 	○	N2
    filter
	 	 	 	○	Sprayball
	 	 	●	Bottom
    connections:
	 	 		○	Product
    outlet
	 	 		○	Connection
    for agitator
	 	 	●	Agitator
	 	 	 	○	Stainless
    steel 316L, surface finish of 15Ra μin and Electropolished (BPE SF-4)
	 	 	 	○	Bottom
    mounted
	 	 	 	○	VS


 


	 	The
    new off gas tank will have the following characteristics:
	 	●	Glass
    lined Carbon Steel Tank with Epoxy Paint
	 	●	Working
    volume: 300 L
	 	●	Design
    pressure: 15 PSIG & F.V.
	 	●	Top
    connections:
	 	 	○	Product
    inlet port
	 	 	○	Vent
    port
	 	 	○	N2
    port
	 	●	Bottom
    connections:
	 	 	○	Product
    outlet


 


	 	17.2.5.3.5
    Fractionation


 


The
fractionation equipment consists of an agitated 700 L fractionation tank (T-957) using 70 kD fractionation filters and a 30 kD concentration
filter.


 


This
system is pre-existing system being relocated and will not be modified.


 


	 	17.2.5.3.6
    Filtrate Recovery


 


The
filtrate recovery equipment consists of a 700 L filtrate recovery tank (T-958) using 30 kD filtrate recovery filter.


 


This
system is pre-existing system and will not be installed in this project. A space holder has been used for this future use on the layout.


 


www.protecsinc.com


 




    	74



     


    

 


 


	 	17.2.5.3.7
    Final Filtration and Pooling


 


The
final filtration equipment consists of a 0.5 μ pre-filter, a 0.2 μ sterile filter and a 0.1 μ final sterile filter
to obtain sterility. The pooling equipment consists of two agitated 1400 L bulk holding tanks (T-991A and future T-991B) maintaining
C-900 product at a temperature of 15- 30oC under a nitrogen blanket until ready for filling.


 


This
system is pre-existing system being relocated. The new bulk holding tank (T-991B) will be new, but will be purchased at a later date
for future use and modeled after T-991A.


 


For
future use: The new bulk holding tank will have the following characteristics:


 


	 	●	Stainless
    steel 316L, internal surface finish of 15Ra μin and Electropolished (BPE SF-4)
	 	●	Working
    volume: 1400 L
	 	●	Design
    pressure: 50 PSIG & F.V.
	 	●	Chilled
    water jacket at 100 PSIG
	 	●	Top
    connections:
	 	 	○	Product
    transfer port
	 	 	○	Vent
    filter
	 	 	○	N2
    filter
	 	 	○	Connection
    for agitator
	 	 	○	Sprayball
	 	●	Bottom
    connections:
	 		○	Product
    outlet
	 	●	Agitator
	 	 	○	Stainless
    steel 316L, surface finish of 15Ra μin and Electropolished (BPE SF-4)
	 	 	○	Top
    mounted


 


	 	17.2.5.4
    Filling / Packaging


 


The
product is transferred from the pooling tank through 0.1 μ sterile filters to the filling machine. This is accomplished using a
combination of sterilized piping and single-use equipment. The location of the pooled bulk holding tanks will be evaluated in relation
to the location of the filling operation. This will be done to minimize potential for product losses and process complexity. In addition,
the requirements and practice of pre-use, post-sterilization integrity testing of the product sterilizing filters will be evaluated per
a risk assessment. If pre-use option is chosen by the client, a filter integrity test apparatus (bubble point test) will be used prior
to sterile filtration of each batch to ensure that the filter is not defective and will not compromise the sterility of the product.*


 


Aseptic
filling of sterile product into ready to use I.V. bags will be performed within a Restricted Access Barrier System (RABS) under an ISO
class 5 (grade A) environment located immediately within an ISO class 7 (grade B) background.


 


www.protecsinc.com


 




    	75



     


    

 


 


The
semi-automatic filling machine previously used at the contract manufacture’s site will be relocated to the HbO2 facility. The filling
machine will print the batch number, open the bag, vacuum the inside of the empty bag, fill it with a pre-set dose of sterile product,
permanently seal the bag, cuts the piece above the weld, and unload the I.V. bag. The filling machine must accommodate bags of two different
sizes (250mL and 500mL).


 


After
filling, the filled I.V. bags are transferred out of the filling room to the labeling and overwrap room where the product is inspected
including leak testing, seal integrity testing and weight checks. The product is then labeled and then inserted into clear overwrap pouches,
purged with nitrogen and sealed under a vacuum. A checkweigher will be used to verify the weights of the filled I.V. bags throughout
the filling operation (samples only – IPC). It is then transferred to product storage. Once an order is filled the product is removed
from storage, individually boxed, labeled, crated and transferred to the warehouse for shipping.


 


Filter
shall be either located under RABS or aseptic connections in non-sterile environments could be achieved using single- use aseptic connectors
from the sterile side of the filter to the filling line product inlet. These connectors are designed for sterile transfer as well as
limiting the risk of human error. The connections are tool-less. They are composed of male and female plugs, pre- sterilized in autoclave
or gamma irradiated.


 


Several
models of aseptic connectors are available on the market:


 


	 	●	Sartorius-stedim:
    Opta Connector
	 	●	Pall:
    Kleenpak Connector
	 	●	Cole-Parmer:
    Asepti-Quik Connector
	 	●	Millipore:
    Lynx S2S Connector


 


	 	17.2.5.4.1
    Part wash room


 


Parts
provided to the aseptic filling room will be cleaned by in the parts wash area located in the equipment preparation room. This will allow
the cleaning of compounding and filling components.


 


	 	17.2.5.4.1
    Autoclave


 


Parts
provided to the aseptic filling room will be sterilized using an autoclave located in the equipment preparation room. This autoclave
will allow sterilization of components required to support filling within the RABS.


 


The
autoclave has the following characteristics:


 


	 	●	Double-door
    (pass-through)
	 	●	Chamber
    size: 1 ft (approximatively)





	 	●	cGMP
    design – Pharmaceutical grade
	 	●	Model:
    TBD
	 	●	Cycles:
	 	 	○	Wrapped
    goods with vacuum drying
	 	 	○	Hard
    goods with fast exhaust


 


www.protecsinc.com


 




    	76



     


    

 .


 


	 	17.3
    PROCESS UTILITES


 


	 	 	17.3.1
    Scope of work
	 	 	 
	 	 	This
    section describes the process utilities required to support manufacturing operations for the HbO2 expansion project.
	 	 	 
	 	 	The
    following items are included in process utilities scope:


 


	 	●	Water
    for Injection (WFI)
	 	●	Clean
    Steam
	 	●	Chilled
    water or glycol
	 	●	Clean
    in Place (CIP) and Clean out of Place (COP)


 


	 	 	New
    mechanical items required for this expansion project scope:


 


	 	●	New
    WFI system to service C-500,C-800 and C-900 operations
	 	●	Relocated
    Clean Steam generator
	 	●	Relocated
    CIP and COP
	 	●	New
    Chilled Water system to service C-800 and C-900 operations


 


	 	 	Additional
    items included in this project scope:


 


	 	●	Clean
    utilities piping (WFI, clean steam, process chilled water/glycol)


 


	 	17.3.2
    Design criteria


 


Clean
and plant utilities are based on the utility requirements for the previous facilities. Clean utilities will be provided utilizing sanitary
piping appropriate for the system.


 


	 	17.3.3
    Clean utilities


 


	 	17.3.3.1
    WFI
	 	 


A
new WFI system will be installed to support all the process activities (including C-500). The generation system with an output of 25
gpm will supply the existing storage vessel in utility room 125. This new generation system is under HbO2 responsibility. The current
distribution will be intercept to fill a new 20 000L storage tank to support C-800/900 operations. Both cold and hot WFI will be available
for the process. The new WFI system will include provisions for periodic in-place heat or chemical system sanitization.


 


The
distribution piping needs to be Stainless steel 316L, surface finish of 15Ra μin and Electropolished (BPE SF-4).


 


RO
reject is estimated at over 90,000 gallons (340,000 L) per week (>40% total process effluent at full capacity, >60% total process
effluent when C-500, C-800 and C-900 are run sequentially).


 


	 	17.3.3.2
    Purified Water (PW)


 


The
HPW tank and distribution system for C-500 operations is a pre-existing system and will be modified to store WFI and supply the new storage
vessel. The current vessel and distribution will not be modified to match the new piping specification requirements (15Ra μin and
Electropolished).


 


www.protecsinc.com


 




    	77



     


    

 


 


A
new WFI tank, cooler and distribution system for C-800 and C-900 operations is needed to service all C-800 buffers, and all CIP and COP
fluids for C-800 and C-900. WFI is also the feed water for the clean steam generators.


 


The
new WFI system is to be maintained and distributed at 80oC with a small cold WFI distribution loop to support commodity prep activities
serviced by a cooling heat exchanger to a set temperature (20 to 30oC). The new WFI system should contain a 20,000 L tank with a
capacity of 60 lpm and a distribution of 300 lpm.


 


	 	17.3.3.3
    RODI Water


 


The
RODI water will be provided for lab use only and will not meet USP requirements. This new system is under HbO2 responsibility.


 


The
distribution piping will be polypropylene IR plus fusion. The loop will supply four faucets and one glasswasher.


 


	 	17.3.3.4
    Plant Steam


 


See
Division 15.0 for details.


 


	 	17.3.3.5
    Clean Steam


 


The
clean steam generator and distribution system for C-500 operations is a pre- existing system and will not be modified.


 


A
similar clean steam system is required for process equipment in C-800 and C- 900 area. A 1,000 lb/hr generator is being relocated from
the Cambridge, MA facility. The new header will be connected to the existing C-500 distribution header which will be expanded so that
both generators are available to service the entire plant. The verification of the existing CS generators is under HbO2 responsibility
and the assumption is that the equipment will be functional.


 


	 	17.3.3.6
    Chilled Glycol


 


The
chilled glycol system for C-500 operations is a pre-existing system and will not be modified.


 


The
chilled water system for C-800 and C-900 operations will be required. The Cambridge, MA facility’s system consisted of a thermal
storage reservoir and two chillers. One 200 ton (700 kW) chiller is used to make the ice circulated through the ice tanks and a 1,500
gallon (5,700 L) reservoir. The second 200 ton (700 kW) chiller is used to cool the returned chilled water before it re-enters the ice
tanks.


 


The
new chilled water system consists into two 200 ton chillers to meet the process requirements (C-800/900).


 


www.protecsinc.com


 




    	78



     


    

 


 


	 	17.3.3.7
    CIP and COP


 


The
CIP system for C-500 operations is a pre-existing system and will not be modified.


 


Two
CIP systems will be relocated from the Cambridge facility, one for C-800 operations and one for C-900 operations. The single tank system
uses saline, sodium hydroxide and phosphoric acid wash fluids. It may service any equipment as the CIP fluids are not returned. The CIP
tank is used to make up the required fluid at its specified temperature and transfer it to the equipment. The CIP fluids are circulated
by either process or CIP pumps located near the equipment and discharged to local process waste drains. Line circuits are washed once
through with flow directly from the CIP tank if they cannot be combined with an equipment circuit.


 


The
COP system for C-500 operations has two COP skids and a parts washer located in a designated wash area. This is a pre-existing system
and will not be modified.


 


Two
COP skids will be relocated from the Cambridge facility to service the C-800 and C-900 equipment. COP is used to clean the various filters
from diafiltration and fractionation. The equipment is moved into a designated COP room and connected to the COP equipment with flex
hoses.


 


One
COP skid will be reinstalled in the room 177A to clean the fractionation filter. This equipment will be a field installation.


 


	 	17.3.3.8
    Insulation


 


Process
and clean utilities piping need to be insulated for personal protection and energy conservation. Here are the general specifications
for the insulation.


 


	 	●	Insulation
    shall be chloride and asbestos free
	 	●	Insulation
    shall not support fungi or bacteria growth
	 	●	Insulation
    shall be smooth surface
	 	●	Insulation
    shall be an easy-to-clean surface free of cracks and cavities that can withstand harsh cleaning agents


 


	 	17.3.3.9
    Process Waste Treatment


 


See
division 15 for details.


 


www.protecsinc.com


 




    	79



     


    

 


 


	 	17.4
    SKID ASSEMBLY


 


17.4.1
General description


 


In
order to expedite the project and reduce cost and provide a design build standard of performance for the C-800 and C-900 manufacturing
trains, PROTECS and LaPorte will work closely with the selected skid manufacturer to develop all final required design documentation
and work through all FAT requirements and PRTOECS will take chain of custody ownership of the skids, shipping, receiving, rigging, installation
and SAT in alignment with the overall project delivery schedule.


 


An
inventory was performed of existing equipment and parts against the process P&IDs to identify components that are existing and components
that must be ordered new. The new components will be ordered by a single source.


 


All
the product contact piping needs to be Stainless steel 316L, surface finish of 15Ra μin and Electropolished (BPE SF-4). The skid
frame and platform need to be stainless steel 304 with clean and smooth surface finish to allow a proper cleaning and sanitization.


 


	 	17.5
    PROCESS AUTOMATION


 


The
automation strategy for the Souderton, PA facility expansion will include a Process Control System (PCS) which will provide supervisory
control/data acquisition for skid mounted equipment with vendor supplied PLC control and direct control of off skid equipment. Each piece
will be equipped with the level of automation it requires. Environmental monitoring and data acquisition functionality will be incorporated
into the PCS system for environmental monitoring instruments within the GMP spaces.


 


The
results of an automation assessment conclude that, primarily due to hardware obsolescence, the Bailey automation system should be upgraded
to modern hardware. Three process control units (PCU) from Cambridge and one in Souderton should be migrated per manufacturer’s
guidelines. Similarly, the pneumatic control panels from both Cambridge and Souderton should be replaced with modern hardware because
the existing hardware is no longer manufactured or supported.


 


The
upgraded DCS and Festo hardware will rely on modern, network-based communication and co-exist on a single, unified plant network. Process
skids from the Cambridge, MA facility will include junction boxes which house the upgraded pneumatic hardware. Souderton pneumatic panels
will be upgraded in their existing enclosures.


 


Networking
hardware, servers, and thick/thin clients will be included to support typical activities including HMI control/monitoring, process data
historian, and alarm reporting. Programming, including migrations, will be included.


 


To
leverage the network infrastructure, all variable frequency drives (VFDs) are recommended to be upgraded or replaced with models that
can support network- based control from the PCS.


 


The
PLC-based control systems in two COP skids from Cambridge, two COP skids in Souderton, and the CIP skid in Souderton should be upgraded
due to hardware obsolescence. In all cases, the PLC and HMI should be upgraded to modern hardware. The existing program will be migrated
to support the new hardware.


 


www.protecsinc.com


 




    	80



     


    

 


 


	III.	DESIGN/BUILD
    PROJECT DISCUSSION


 


	 	1.0
    	General


 


	 	1.1	Staged
    Design Services: We have concluded the preliminary stage of our design services that are represented by this document. This
    effort was used to solicit competitive market prices from key vendors and subcontractors for the work on this project. The effort
    to complete the project design will entail the final design development for construction issue documentation (Bulletin #1 due to
    permit requirements for IFC drawings) (confirmation of work to ensure proper system and component sizing and to provide construction
    administration through the course of the work).
	 	 	 
	 	 	PROTECS
                                            believes we can complete this work by September 2018. We have also planned for the strategic
                                            release of packages to allow for early procurement of materials and vendors’ services
                                            that must be pre-fabricated to lessen the amount of time in the field. Our design team will
                                            remain intimately involved with the field construction throughout the balance of the work
                                            including commissioning. 

	 	 	 
	 	1.2	Project
    Safety: We will implement a vigorous safety program and coordinate all field activities with site safety goals as top priority.
    Our jobs run smoothly and safely as a result of our total commitment to field safety management. We will conduct weekly safety meetings
    and our field staff will routinely monitor field operations with a keen eye toward total adherence to safe practices. PROTECS routinely
    reviews the client site requirements and incorporates them into the comprehensive PROTECS plan. This plan will also be coordinated
    with HbO2.
	 	 	 
	 	1.3	Subcontractors:
    A list of pre-selected approved trade contractors that PROTECS has previously worked with and/or are qualified for the work through
    extensive experience with this type of facility were contacted by PROTECS to develop our pricing for this work. All parties are highly
    capable and well-staffed organizations that can meet both the HbO2’s and PROTECS’ needs and requirements. Additionally,
    subcontractors/vendors at the request of HbO2 and the landlord have also been contacted to develop the pricing for this work.
	 	 	 
	 	1.4	Construction
                                            Management: This project demands efficient execution and thorough planning. Our logistics
                                            plan calls for management of subcontractors led by a project manager from PROTECS who is
                                            supported by a project engineer and superintendent as well as home office planning and cost
                                            control staff. Through these efforts by a single source, HbO2 will realize coordination benefits. 



 


www.protecsinc.com


 




    	81



     


    

 


 


	 	 	Along
    with the selection of talented subcontractors, successful implementation must include an aggressive expedition and scheduling
    program. We will establish short-term schedules, hold frequent coordination meetings with subcontractors regarding scheduling, quality,
    and safety and establish a very detailed progress measurement system that will allow for confident tracking and control.
	 	 	 
	 	 	Our
    team is familiar with your facility, the personnel we have been introduced to, the demands of your market place, and the area trade
    contractors. With our personnel on site full-time, we will maintain the right management team on your project at all times.
	 	 	 
	 	1.6	Purchasing/Expediting:
    We propose to undertake an aggressive pre- purchase and expediting program in order to meet the scheduled activities. We have outlined
    this in our schedule. We believe the key facets to a successful timely delivery of this project will center around the early release
    of the process skid assembly scope, major mechanical and electrical equipment (i.e. boiler, AHUs, waste neutralization system) and
    key subcontractors.
	 	 	 
	 	1.7	Permits:
    Our office has been in contact with Franconia Township and the permit applications were submitted and permit approvals were recently
    received. We can present them with a single point of contact for both the design and construction questions they may have since our
    team is integral within our office.
	 	 	 
	 	1.8	Cost
    Control: We will establish a detailed cost control budget for the project and will work closely with major subcontractors
    to develop a coordinated cost reporting system. We will carefully measure engineering and field progress and deploy our change control
    program for timely identification of potential issues for team discussion. We will clearly define status, progress, and projected
    final totals in a meaningful way. We will support any cost saving/value engineering opportunities that arise to assure HbO2 that
    a cost-efficient facility is being provided that meets immediate occupancy needs, as well as accommodates longer-term objectives
    where prudent and possible. Our expert cost engineering capabilities will pay a vital role in the cost control program for the project.


 


www.protecsinc.com


 




    	82



     


    

 


 


	 	2.0	SCOPE
    OF SERVICES
	 	 	 
	 	PROJECT
    MANAGEMENT 


 


	 	2.1	The
    work will be broken down by construction packages that best fit HbO2’s needs. PROTECS will procure the project in packages
    according to client production needs, relocation dates, permitting requirements, design constraints, and equipment delivery requirements.
	 	 	 
	 	2.2	PROTECS
    monitors cost through the use of several systems. Change requests (CR) are issued immediately upon identification of changes in the
    overall project scope. This allows our clients the ability to react to changes and make decisions based on cost and schedule impacts.
    Likewise, PROTECS uses a system for Potential Change Orders (PCOs) to track the subcontractor changes. We also monitor and track
    the progress of the project against our detailed CSI coded cost breakout and the project schedule in support of project invoices
    to HbO2 and from subcontractors.
	 	 	 
	 	2.3	Time
    Management and Project Scheduling is the key tool for project success. A Project Milestone Schedule has been provided with this quotation.
    At the start of the project, PROTECS will prepare and link all activities required for the design, procurement, and construction
    of the project. The schedule is an active document to provide the team with the plan for a successful project. Changes are incorporated
    and evaluated and progress will be tracked on a weekly basis. Once the baseline schedule is developed, a Critical Path schedule will
    be established. Any deviation to the Critical Path Method will be evaluated and work around plans provided. The schedule will be
    maintained in MS Project.
	 	 	 
	 	2.4	Risk
    Management is a function of good communication. The PROTECS Project Manager will work closely and communicate with HbO2 to identify
    and evaluate risk. PROTECS typically works with its clients to identify client business plans to enable review of design and procurement
    construction activities for potential risk. PROTECS will assist to evaluate these issues and manage the subsequent activities accordingly.
	 	 	 
	 	2.5	Project
                                            Reporting and Control Systems are provided to meet the client and project needs. As previously
                                            discussed, cost and schedule are monitored and updated regularly. PROTECS will conduct client
                                            project review meetings on a bi-weekly (weekly, when necessary) basis and site contractor
                                            review meetings on a weekly basis. PROTECS also conducts in-house design coordination meetings
                                            on a weekly basis (through the design phase) in addition to drawing reviews and constructability
                                            reviews that are conducted as needed throughout the project. The frequencies of meetings
                                            are adjusted to meet the project needs.

     



 


www.protecsinc.com


 




    	83



     


    

 


 


	 	2.6	Document
    Management is initiated on a project specific basis. The Project Lead Sheet will contain the drawing and revision dates for the project.
    Specifications are logged by number and date. All distributions are issued and accompanied by a transmittal, containing the description,
    revision dated, and distribution.
	 	 	 
	 	2.7	Configuration
    and Change Management are managed through our CR and PCO (work order) documents. Changes in construction packages are controlled
    through the issuing of bulletins and all contractor questions are written on a standard Request for Information format.
	 	 	 
	 	2.8	Records
    Management. All project related documents are filed in the project file, which is regulated through a standard filing system. Documents
    are issued via a transmittal and correspondence is coded. Logs are kept electronically and backed up daily.
	 	 	 
	 	2.9	Project
    Coordination. All PROTECS services for this project are delivered through one office; this allows for easy access and for a smooth
    flow of information. The project group is linked via an email system and can easily access common software through the company computer
    system. Formal meetings are organized with an agenda and minutes are kept and issued. All issues are surfaced, distributed, and resolved
    in an efficient manner. The aforementioned activities of scheduling and cost control are additional tools used to coordinate and
    prioritize the activities performed by the project team.
	 	 	 
	 	2.10	Project
    Lists will be provided and are typical for: 





 





	 	 	Drawing
    List
	 	 	Specification
    Log
	 	 	Document
    Distribution List 
	 	 	Shop
    Drawings / Expediting Log 
	 	 	PCO
    Log
	 	 	CR
    Log
	 	 	 
	 	 	Additional
    lists will be provided as the project requires.


 


www.protecsinc.com


 




    	84



     


    

 


 


	 	3.0	FINAL
    ENGINEERING AND DESIGN


 


	 	3.1	Detailed
    Design & Construction Documentation Phase
	 	 	 
	 	Listed
    below is a summary description of the anticipated design deliverables to complete the design through the construction documentation
    phase of the work: 


 


	 	1.	Develop
    and issue pre-purchase specifications for long lead equipment and respond to questions and clarifications.
	 	2.	Final
    Construction Drawings.
	 	3.	Required
    project meetings.
	 	4.	Subcontractor
    assistance.
	 	 	●	Respond
    to questions / clarifications from contractors
	 	 	●	Technical
    evaluation of work scopes


 


	 	3.2	Construction
    Phase (Construction Administration)
	 	 	 
	 	Listed
    below is a summary of anticipated deliverables by the PROTECS’ architect and engineer to support the construction phase effort
    of the project: 


 


	 	1.	Shop
    drawing reviews.
	 	2.	Respond
    to Requests for Information (RFIs).
	 	3.	Conflict
    resolution during construction.
	 	4.	Periodic
    construction site visits by each discipline. We have assumed key design engineers will visit at various stages of construction.
	 	5.	Prepare
    field observation reports and punch lists by each discipline.
	 	6.	Assist
    in commissioning of systems by providing general guidance.
	 	7.	Review
    commissioning report.


 


	 	3.3	Record
    Drawings
	 	 	 
	 	Listed
    below is a summary of the anticipated deliverables by PROTECS in support of the project close-out: 


 


	 	1.	Review
    subcontractor as-built drawings.
	 	2.	Architectural,
    Structural, Mechanical, Plumbing, Process, and Electrical Deliverables.





 


The
    anticipated drawing list is made up of all the drawings attached at the end of this document. 


 


www.protecsinc.com


 




    	85



     


    

 


 


	 	4.0	PROCUREMENT,
    CONTRACT ADMINISTRATION AND CONSTRUCTION MANAGEMENT


 


	 	4.1	Procurement


 


	 	1.	Develop
    and issue pre-purchase specifications for long-lead equipment.
	 	2.	Provide
    early bid packages to confirm work scopes in accordance with approved design documents.
	 	3.	Provide
    purchase orders for owner-selected long-lead equipment.


 


	 	4.2	Contract
    Administration


 


	 	1.	Work
    scope walk-through meetings.
	 	2.	Respond
    to questions/clarifications from bidders/contractors (RFI’s).
	 	3.	Evaluation
    of bids.
	 	4.	Awarding
    contracts.
	 	5.	Shop
    drawing reviews.
	 	6.	Periodic
    construction site visits.
	 	7.	Punch
    listing.
	 	8.	Assist
    in commissioning of systems by providing general guidance.
	 	9.	Review
    commissioning report.


 


	 	4.3	Construction
    Management


 


	 	1.	Full
    time on-site supervision.
	 	2.	Preparation
    and monitoring of project schedules.
	 	3.	Safety
    standard enforcement.
	 	4.	Coordination
    of owner furnished items.
	 	5.	Site
    cleanliness.
	 	6.	Preparing
    and maintaining cost accounting procedures that track costs to date and costs to complete.
	 	7.	Expediting
    long lead equipment.
	 	8.	Monitoring
    subcontractor progress cost and change requests.
	 	9.	Reviewing
    major discipline scopes and pricing versus budget with HbO2.
	 	10.	Subcontractor
    coordination.
	 	11.	Quality
    Assurance.
	 	12.	Job
    Site Office.
	 	13.	Shutdown
    Coordination.
	 	14.	Estimating
    of alternatives or scope change requests.
	 	15.	Constructability
    Review.
	 	16.	Pre-purchase
    of Equipment.
	 	17.	Contract
    Administration.


 


www.protecsinc.com


 




    	86



     


    

 


 


	 	5.0	COMMISSIONING
    AND QUALIFICATION SERVICES


 


	 	5.1	Introduction
	 	 	 
	 	 	The
                                            Commissioning and Validation Master Plans (VMP) will be drafted/developed by HbO2 for the
                                            project to define the approaches to be taken for commissioning, qualification and validation
                                            of the facility, equipment and utility systems related to HbO2’s project. The facility
                                            will be designed to comply with all current industry, regulatory and HbO2’s requirements.
                                            To date, PROTECS has used the previous validation/qualification documentation to develop
                                            the design and this proposal. A project Validation Master Plan (master plan) is required
                                            for the project to define the approaches to be taken for the commissioning, qualification,
                                            and validation of the facility, equipment, and utility systems related to HbO2’s project.

     



 


	 	5.2	Scope
	 	 	 
	 	 	PROTECS
    will provide equipment start-up services for new equipment and provide it’s standard pre-functional and functional commissioning
    documentation for the major equipment installed including the following equipment:


 


	 	●	AHUs,
	 	●	Humidifiers
	 	●	Air
    compressor
	 	●	Boiler
	 	●	Generator
	 	●	Chillers
	 	●	Waste
    Neutralization System


 


www.protecsinc.com


 




    	87



     


    

 


 


	IV.	CLARIFICATIONS
	 	 
	 	Following
    is a summary listing of the qualifications, clarifications, and assumptions we have made in developing this document.


 


	 	1.0	General


 


	 	1.1	This
    proposal and all contents of our offer expressed herein are confidential and privileged cannot be disclosed to parties outside of
    PROTECS and HbO2 Therapeutics without the specific written permission of PROTECS. Dissemination, distribution, or copying of this
    document or any portion thereof by any party other than PROTECS is strictly prohibited.
	 	1.2	HbO2
    will be responsible for equipment and building system maintenance and control upon completion of start-up and training.
	 	1.3	All
    documents will be prepared in accordance with PROTECS standards.
	 	1.4	All
    documents delivered electronically as part of the final submittal will be in AutoCAD 2013, Microsoft Project, Microsoft Office, or
    Adobe PDF formats.
	 	1.5	Vendor
    documents will be furnished in the usual publication formats provided by the vendor.
	 	1.6	Redline
    As-built drawings will be provided based on subcontractor mark-ups. The P&ID drawings will be updated in CAD to incorporate contractor
    mark-ups.
	 	1.7	Tax
    costs in this proposal have been excluded based on HbO2 providing the appropriate PA state tax form for PROTECS to file with vendors
    and subcontractors.
	 	1.8	All
    unit costs in the $GMP identified as “ALLOW” represent an allowance for that particular line item that is the maximum
    financial responsibility of PROTECS within the $GMP. Any costs for any line item with unit cost of “ALLOW” in excess
    of the indicated amount will be in addition to the $GMP.
	 	1.9	The
    proposal is based on the work schedule attached hereto and milestone dates identified therein.
	 	1.10	The
    contingency is exclusively meant to pay for all the cost associated with estimating variances, work associated with further design
    development to meet the basis of design criteria, etc. The purpose of the contingency, however, is not to pay for additional work
    requests or scope adjustments by HbO2 or cost associated with force majeure (i.e., Acts of God, labor strife, strikes, etc. or field
    conditions).
	 	1.11	Our
    proposal is based on mutually agreed terms based on an AIA 191 Owner/Design-Builder contract document.
	 	1.12	PROTECS
    standard insurance coverage will be acceptable for the project.
	 	1.13	Payment
    and performance bonds have been excluded.
	 	1.14	Builders
    Risk Insurance will be provided by HbO2.
	 	1.15	One
    hard copy and one digital copy of as-built drawings and IOM manuals will be provided as part of this scope of work.


 


www.protecsinc.com


 




    	88



     


    

 


 


	 	1.16	PROTECS’
    standard one-year warranty on labor and materials is provided. Additional warranty requirements beyond these terms have not been
    included at this time.
	 	1.17	The
    order of precedence for the documents provided as part of this proposal is $GMP Clarifications/exclusions within this document, $GMP
    Basis of System Criteria, then the issue for construction drawings.
	 	1.18	This
    $GMP is made up of multiple project costs that contain individual line items, all of which comprise this $GMP. It is understood that
    no guarantee exists on any single item of work, and that dollar savings on a particular trade discipline may be transferred to cover
    possible overruns of another.
	 	1.19	This
    proposal is based on being paid for materials stored off site.
	 	1.20	General
    conditions include costs associated with the supervision and management of permitting, procurement, and construction activities throughout
    the duration of the project. The proposal is based on the work schedule attached hereto and milestone dates identified therein. Any
    work associated with General Conditions extending beyond the schedule indicated due to revisions directed by the owner are excluded.
	 	1.21	Fee
    is shown as a percentage of costs only for the overall presentation of the costs. It remains to be a fixed amount for the given scope
    whether there are cost savings on the project or otherwise. The fee for Owner requested additional work will be calculated at the
    same percentage basis. If the project scope increases, the fee and overhead also increase either at the same percentage rate as the
    shown in the $GMP breakdown or on the basis of requirements dictated by the project schedule and job conditions-whichever is applicable.


 


	 	2.0	Design


 


	 	2.1	The
    layout of the space and equipment is based on the drawings attached in the Appendix of this proposal.
	 	2.2	The
    layout and design is based on the equipment matrix dated February 27, 2017.
	 	2.3	We
    have based our efforts on the conceptual information and utility information provided by HbO2. We have done our best to estimate
    discrepancies or missing components in the information. These will be sorted through before the drawings can be finalized.
	 	2.4	Other
    chemicals will be provided by HbO2 and will be stored in appropriate cabinets, provided by HbO2, suited for the purpose of storing
    such chemicals per NFPA code requirements.
	 	2.5	Refer
    to the Hazardous Material Information BOSC902 drawing dated February 27, 2017 for the chemicals and quantities anticipated for the
    facility.
	 	2.6	Adequate
    and approved water supply to support the demand of the potable water system and sanitary water is understood to be available at the
    site. The pressure fluctuation of this system must be evaluated against the selected equipment requirements during design development.


 


www.protecsinc.com


 




    	89



     


    

 


 


	 	2.7	Adequate
    and approved water supply to support the demand of the DI water system is understood to be available at the site. The pressure fluctuation
    of this system must be evaluated against the selected equipment requirements during design development.
	 	2.8	Environmental
    engineering, air permits, and/or other discharge permits are not included.
	 	2.9	The
    initial layout of the facility provides for cGMP compliance.
	 	2.10	The
    cleanroom area construction materials specified are resistant to the chemicals identified by HbO2 during the design process. PROTECS
    shall not be responsible for damages caused by improper use, changes to the cleaning procedures or use of chemicals not identified
    by HbO2 during the design process.
	 	2.11	This
    proposal and fees presented herein are based on PROTECS providing full design build services for the project. Should PROTECS provide
    design services only, the cost for these services will have to be increased accordingly.
	 	2.12	This
    proposal includes a complete design package as required to obtain permitting approval from the local governing authorities, Franconia
    Township, PA, and full time on-site PROTECS supervision and coordination of all trades and subcontractors performing the work.
	 	2.13	Health
    and Safety reviews for HAZOPs are not included.
	 	2.14	An
    as-built basis of system criteria or basis of design is not included.
	 	2.15	The
    services under this scope will be provided with the diligence and a standard of care consistent with and equal to the prevailing
    practices of similar professional organizations providing similar services within this industry and geographical area.
	 	2.16	PROTECS
    cannot be held responsible for schedule impact due to failure of local building officials to approve building permit by date indicated
    on the Project Schedule. PROTECS is not responsible for schedule impact due to failure of code officials to provide inspections of
    installed work in a reasonable period of time.
	 	2.17	The
    design and construction is based on the known national code requirements. Any requirements above and beyond these standards that
    may be required by the Owner’s insurance provider or by the local authority having jurisdiction (that are not published at
    the time the design was commenced) are not included as part of this work.
	 	2.18	The
    site is not in a flood zone.
	 	2.19	The
    engineering services for this project are offered on a lump sum basis and include the credit for the Permit to $GMP services.
	 	2.20	The
engineering fee is fixed based on the $GMP proposal submitted on September 11, 2017. Additional engineering fees will not be added to
the Process Automation and Process Materials procurement scopes that will be added into the project as long as they do not exceed the
allowance amounts carried in the September 11, 2017 $GMP estimate.



 


www.protecsinc.com


 




    	90



     


    

 


 


	 	3.0
    	Scope
    – Trade / Site
	 	 
	 	The
    items below are meant to clarify or amplify the scope of the work. Although they are listed by division, they apply to the project
    as a whole (i.e., they are not limited to the work of any specific trade).





 


	 	General
    
	 	 	 
	 	3.1.1	This
    proposal is solely based upon the material and quantity descriptions identified in this proposal and associated cost breakdown.
	 	3.1.2	The
    proposal is based on working over a period of 8 hours/day, between 7:00 AM and 5:00 PM during the week, Monday through Friday unless
    stated otherwise. The normal workday for the project site will be 7:00 AM to 3:30 PM.
	 	3.1.3	The
    estimate is based on receiving all construction areas clean and clear on the agreed-upon dates. The cleaning and clearing of the
    spaces of owner furniture prior to construction is not included as part of this estimate; however, we can provide services to assist
    your office in coordinating this work as an optional cost.
	 	3.1.4	We
    have not included any future allowances for cost impacts or escalation in regard to the current issues with shortages of copper,
    concrete, steel, and related products, materials, and equipment (steel, reinforcing bar, conduit, ductwork, piping, HVAC equipment,
    electrical gear, etc.). Any cost impacts related to this issue will be addressed as an added cost to the project scope, as necessary.
	 	3.1.5	We
    have allowed for a separate construction site office for this project within the existing building space including office space for
    PROTECS project team and with telephone and data lines available from within the building. PROTECS will have full use of the conference
    room and (3) offices throughout the construction activities. An alternate is provided for a separate onsite construction office if
    these spaces cannot be provided to PROTECS.
	 	3.1.6	This
    scope is based on gaining access to the building on October 2, 2017.
	 	3.1.7	Delays
    in the project start date will cause corresponding delays in the project substantial completion date.
	 	3.1.8	PROTECS
    has accounted for covering HbO2’s site specific orientation and safety training coincident with our safety and site orientation
    provided to our materialmen working on site and that HbO2’s orientation and safety issues can be covered within a thirty minute
    time frame.
	 	3.1.9	The
    budget reflects that the project is to be built by ‘merit shop’ labor. Specific trades will utilize union labor as required
    for the cleanroom wall panel installation.


 


www.protecsinc.com


 




    	91



     


    

 


 


	 	3.1.10	PROTECS
    will coordinate any work that will require the shutdown of existing switches, valves, etc. within the facility. HbO2 will provide
    staff personnel to close/open existing valves and switches that are required during this work.
	 	3.1.11	All
    utility work is included to only five feet outside the building line except the electrical service upgrade which extends to the existing
    pad mount transformer location.
	 	3.1.12	All
    existing utilities that are being connected to have been maintained, are functional, and are not clogged, blocked, etc. No remedial
    work will be required for these existing systems.
	 	3.1.13	See
    the site logistics plan for access, laydown, storage, temporary protection and dumpster locations.
	 	3.1.14	The
    Conex boxes onsite will be available for PROTECS use for storage of materials.
	 	3.1.15	It
    is assumed that all existing systems are operational. HbO2 will be responsible for re-starting all existing equipment and systems.
    PROTECS can assist with this work if required at additional cost.
	 	3.1.16	All
    owner furnished equipment/materials will be located at the site or in the warehouse located at 300 Enterprise Lane, Colmar, PA.
	 	3.1.17	Vendors
    warranties are pass through warranties.


 


	 	Site
	 	 	 
	 	3.2.1	Construction
    debris will be removed from the site by containers provided under this scope.
	 	3.2.2	Temporary
    protection will be provided as depicted on the site logistics plan.
	 	3.2.3	Subcontractor
    parking will be onsite in the site’s parking lot. The parking lot wearing layer and stripping will be completed by others after
    completion of construction.
	 	3.2.4	The
    soil bearing capacity was based on the Geotechnical report (File No. 14-90554- 02) dated January 21, 2015 prepared by Gilmore &
    Associates.
	 	3.2.5	The
    pricing is based on being able to use the material excavated for the project as backfill material around the foundations, cut/fill
    operations, and site grade adjustments.
	 	 	 
	 	Concrete
	 	 	 
	 	3.3.1	It
    is assumed the existing concrete slab is no greater than 6” thick.
	 	 	 
	 	Masonry
	 	 	 
	 	3.4.1	Intentionally
    left blank.
	 	 	 
	 	Structural
	 	 	 
	 	3.5.1	An
    AISC certified erector will not be required for steel erection. 3rd Party steel inspections will be performed.


 


www.protecsinc.com


 




    	92



     


    

 


 


	 	Carpentry
	 	 	 
	 	3.6.1	Intentionally
    left blank.
	 	 	 
	 	 	Thermal
    and Moisture Protection
	 	 	 
	 	3.7.1	Non
    penetrating pipe and duct supports will be provided where possible.
	 	 	 
	 	Doors
    and Windows
	 	 	 
	 	3.8.1
    	It
    is assumed the exterior doors have been prepped to receive the card reader hardware.


 


	 	Finishes
    	 
	 	 	 
	 	3.9.1	The
    epoxy flooring system specified is based on cart traffic and hand trucking on rubber and plastic wheels with a maximum load of no
    more than 1,000 lbs.
	 	3.9.2	Colors
    at all products are manufacturer’s standard unless indicated otherwise. PROTECS has allowed for a calcium chloride moisture
    test in the area. PROTECS excludes testing the substrate for hydrostatic and/or osmotic pressure prior to installation of epoxy floor.
	 	3.9.3	Bottled
    gases such as nitrogen and associated panels will be provided by HbO2.
	 	3.9.4	EIFS
    removal to the backer board or CMU block has been included. Replacement of the backer board or mold remediation have not been included,
    but can be provided at additional cost.
	 	3.9.5	It
    is understood that HbO2 will provide the necessary Dagard cleanroom wall panels and associated hardware for installation. The Dagard
    cleanroom wall panel system will be stored local (within 20 min) to the jobsite and transportation of the materials from this location
    to the jobsite is included. New materials and hardware for the ceilings, doors and cleanroom windows will be provided by PROTECS.
    Additional materials required for a complete installation can be provided at additional costs if materials are not provided by HbO2.
	 	3.9.6	The
    polished concrete flooring will show the existing concrete aggregate and the condition of the concrete will determine the final finish.
    No provisions are included to replace existing concrete.
	 	Specialties	 
	 	 	 
	 	3.10.1	The
    wall protection will be limited to SS corner guards. SS wall protection has been provided as an alternate.
	 	3.10.2	All
    cleanroom gowning, garments, and accessories will be furnished by HbO2 as a basis for this proposal.
	 	3.10.3	Lockers
    will be installed on “Z” bases in lieu of a concrete pad.


 


www.protecsinc.com


 




    	93



     


    

 


 


	 	Equipment
	 	 	 
	 	3.11.1	The
    process equipment provided by HbO2 will arrive at the site in time to be installed in coordination with the construction of the production
    area.
	 	3.11.2	Procurement,
    unloading, rigging, installation, commissioning and validation of any HbO2 equipment have not been included unless specifically identified
    elsewhere in this document.
	 	Furnishings
	 	 	 
	 	3.12.1	The
    lab casework for the project will be used with new epoxy tops.
	 	3.12.2	Fumehood
    certification is not included.
	 	 	 
	 	Special
    Construction
	 	 	 
	 	3.13.1	The
    rigging of the roof top equipment for the project can be done from the parking lot adjacent to the project work area during normal
    working hours.
	 	 	 
	 	3.13.2	The
    existing cold box to be relocated is assumed to be in good working order and repairs/replacement of equipment/parts is not included.
    The existing wall and ceiling panels are to be re-used and replacement of damaged panels is not included, but can be provided for
    additional cost.
	 	Conveying
    Systems
	 	 	 
	 	3.14.1	Intentionally
    left blank
	 	Mechanical
	 	 	 
	 	3.15.1	Adequate
    and approved water supply to support the demand of the fire water, potable water, and sanitary water is understood to be available
    at the site.
	 	3.15.2	Temporary
    heating and cooling will be done using the new HVAC equipment.
	 	3.15.3	Safety
    showers are not connected to a drainage system.
	 	3.15.4	Standard
    Flexible ductwork with R-6 insulation factor will be provided.
	 	3.15.5	SS
    316 tubing with Swagelok compression fitting will be provided for connection to process equipment in the production space for N2,
    VAC and Compressed Air.
	 	3.15.6	HEPA
    integrity testing will be based on the factory tests. HEPA filter certification and room certification testing will be completed
    by HbO2.
	 	3.15.7	The
    HbO2 furnished chillers are assumed to meet the performance specifications provided to PROTECS. Modifications/repairs to the chillers
    are not included, but can be provided at additional cost.
	 	3.15.8	The
    lab RODI water system will be furnished and installed by HbO2. Distribution piping to use points as indicated will be provided.
	 	3.15.9	Polyisocyanurate
    insulation with a PVC jacket will be provided in the cleanroom areas for the chilled/warm glycol piping.
	 	3.15.10	Standard
    validation documentation for execution by HbO2 will be provided with the CFR 21 Part 11 compliant monitoring system. Custom validation
    documentation is not included, but can be provided at additional cost.


 


www.protecsinc.com


 




    	94



     


    

 


 


	 	3.15.11	HEPA
    filter module housings will be of aluminum construction (housing is located above ceiling and is not exposed to the cleanroom) and
    the cleanroom exposed perforated grille and perimeter trim will be 304 SS.
	 	3.15.12	BAS
    graphics will be created or modified to depict the new control systems.
	 	3.15.13	BAS
    standard point and program checkout is included. Loop checks and field calibration are not included.


 


	 	Electrical
	 	 	 
	 	3.16.1	We
    have allowed for MC cable for lighting and power branch circuit conduit and wire within designed spaces.
	 	3.16.2	HbO2
    will pay all utility company charges for permanent or temporary services including consumption.
	 	3.16.3	All
    underground electrical conduit to be PVC schedule 40.
	 	3.16.4	Proposal
    and pricing for the electrical work is based on Copper wire pricing received at the time of the proposal. Our suppliers will not
    guarantee wire pricing beyond a one day period. PROTECS reserves the right to adjust the project proposal pricing shown to reflect
    any increases in copper wire proportional to the quantities in the project and the base price of copper current at the time wire
    can be purchased.
	 	3.16.5	Individual
    fixture support wires for air devices and light fixtures are not included.
	 	3.16.6	The
    HbO2 furnished generator is assumed to include the equipment and performance criteria noted on the reviewed generator submittal.
    Modifications and repairs to the generator are not included, but can be provided at additional cost.
	 	3.16.7	The
    VFDs to be provided carry a 5 kAIC rating with a non-barrier bypass. The 75 kAIC rating and barrier bypass can be provided at additional
    cost.
	 	Process
	 	 	 
	 	3.17.1	PROTECS
    will direct and coordinate LaProte’s efforts in a design build manner for the skid assemble scope of work.
	 	3.17.2	Passivation
    is not included, but will be required. The Passivation scope can be provided at additional cost.
	 	3.17.3	No
    spare parts are included in the scope.
	 	3.17.4	The
    purchase of required software and license if necessary is by HbO2
	 	3.17.5	No
    shop calibration will be performed prior to final site installation for existing equipment. Existing instruments are assumed to be
    suitable for calibration.
	 	3.17.6	If
    the materials procurement scope is removed from the scope of this proposal, the costs expended to date will be removed from the credit
    amount to HbO2.
	 	3.17.7	No
    guarantee is provided on the process performance of the skid (i.e. product yield, etc.)
	 	3.17.8	SOPs
    and Batch Records are by HbO2.


 


www.protecsinc.com


 




    	95



     


    

 


 


	 	3.17.9	It
    is assumed that all HbO2 furnished materials and equipment are in good working order and have the necessary documentation (model
    and serial number, material certificates and surface finishes, weld log, calibration certificates as applicable). If material and
    surface finish certificates are missing for existing equipment, an inspection can be performed at additional cost.
	 	3.17.10	Warranty
    does not extend to equipment or parts provided by others and installed under this proposal.
	 	3.17.11	The
    demolition of the existing Process RODI water system and installation of the new WFI Generation system will be completed by HbO2.
	 	3.17.12	Validation
    writing and execution is by HbO2.
	 	3.17.13	FAT/SAT
    writing and execution is included and availability of HbO2 personnel is required for input/review in a timely manner.
	 	3.17.14	IQ/OQ
    is by HbO2.
	 	3.17.15	The
    filling equipment will be furnished and installed by HbO2. The recommended modifications will be completed by HbO2. The particulate
    monitoring system that is required is to be provided by HbO2. The risk assessment and design of the monitoring system can be provided
    at additional cost.
	 	3.17.16	The
    Process Automation Engineering is included, but the installation costs (including wiring and field calibration) are not included.
    The Process Automation installation scope can be provided at additional cost.
	 	3.17.17	The
    Process System Components Procurement (Skid, Non-Skid & Automation) costs are not included and will be addressed once a final
    parts purchase list has been developed and agreed to by HbO2, PROTECS & LaPorte.
	 	 	 
	 	Commissioning
    / Qualification 
	 	 	 
	 	3.18.1	Any
    required gas, water or environmental microbiological sampling will be performed by HbO2.
	 	3.18.2	All
    sampling materials will be obtained by HbO2.
	 	3.18.3	The
    approach to control system testing will be complete functional testing. Code review is not included in the scope of work. PROTECS
    can provide code review, if requested by HbO2. § 21 CFR Part 11 compliance assessments for the equipment PLCs / control systems
    are not included in the scope of work. PROTECS can quote this separately after reviewing the systems and documentation provided by
    the vendor.
	 	3.18.4	Commissioning
    costs include all of the new facility equipment only and do not include any existing or process systems. Commissioning costs
    include costs associated with the applicable subcontractor’s standard commissioning procedures. Commissioning procedures, guidelines,
    and forms required by the owner are excluded. Validation is also excluded.
	 	3.18.5	The
    writing of operations and maintenance SOPs is by HbO2.


 


www.protecsinc.com


 




    	96



     


    

 


 


	 	3.18.6	The
    development of URS is by HbO2 and will need to match the design. Design changes due to URS requirements are not included.
	 	3.18.7	No
    warranties cover fitness for use, merchantability or purpose / use.


 


	 	4.0	Exclusions
	 	 
	 	 	Work
    not included:


 


	 	4.1.1	Builder’s
    risk insurance and associated deductible.
	 	4.1.2	LEED
    requirements.
	 	4.1.3	Building
    permitting and expediting. We have assumed HbO2 will directly pay all state and local permit fees. We will process and file for local
    permits on HbO2’s behalf.
	 	4.1.4	Payment
    and performance bond.
	 	4.1.5	Utility
    company consumption charges.
	 	4.1.6	Rock
    excavation.
	 	4.1.7	Office
    furnishings.
	 	4.1.8	Snow
    and ice removal.
	 	4.1.9	Premium
    time / acceleration of schedule.
	 	4.1.10	Room
    identification and signage.
	 	4.1.11	Excavation,
    except at new foundations and plumbing trenches.
	 	4.1.12	Handling,
    removal, and disposal of toxic or hazardous materials in or within the soil is not part of this work. These materials will have to
    be addressed if and when encountered during the course of the work.
	 	4.1.13	Site
    security, exterior lighting, etc. during the course of construction.
	 	4.1.14	Painting
    of piping, conduit, and insulation. Manufacturer’s standard painting will be provided on equipment and will be touched up in
    the field if necessary due to installation damage.
	 	4.1.15	Seismic
    hangers and/or earthquake bracing.
	 	4.1.16	Spray
    fireproofing of the steel structure.
	 	4.1.17	Cleanroom
    furniture,workstations or accessories.
	 	4.1.18	A
    dedicated fire watch service during the construction process.
	 	4.1.19	Site
    security services.
	 	4.1.20	Civil,
    environmental, equipment and process engineering.
	 	4.1.21	Planning
    board documents and/or meetings
	 	4.1.22	Waste
    permits, waste discharge permits, air permits, and other discharge permits.
	 	4.1.23	Field
    calibration.
	 	4.1.24	Window
    treatment
	 	4.1.25	Roof
    and equipment screening.
	 	4.1.26	Water
    meter, sewer, or assessment fees.
	 	4.1.27	Laboratory
    hoods.
	 	4.1.28	Biosafety
    cabinets.
	 	4.1.29	Room
    particulate and pressure testing.


 


www.protecsinc.com


 




    	97



     


    

 


 


	 	4.1.30	Explosion
    venting.
	 	4.1.31	Utility
    company (i.e., POWER COMPANY, GAS COMPANY, TELE/DATA COMPANY, etc.) installation charges, usage charges or other fees. HbO2 to negotiate
    these items and related charges, costs, or fees directly with the utility company.
	 	4.1.32	Special
    electrical systems (i.e., speakers, Muzak, PA, paging, intercom, clocks, sound masking, security, cameras, monitors, card readers,
    TV cables, TV antennas, AV, etc.).
	 	4.1.33	Special
    grounding systems, ground grids, ground loops, ground rods, grounding risers, or other special “power quality” systems.
	 	4.1.34	Warehouse
    racks.
	 	4.1.35	Revisions
    to existing systems affected by relocated equipment from those systems.
	 	4.1.36	Temporary
    fencing for “lay-down” areas or site storage areas.
	 	4.1.37	Trade
    remobilization other than what is indicated in the project schedule and associated staging and phasing plan.
	 	4.1.38	Sloping
    or leveling of the existing floor.
	 	4.1.39	Site
    filter challenge tests.
	 	4.1.40	Ultrasonic
    testing.
	 	4.1.41	Slab
    x-rays.
	 	4.1.42	Temporary
    sanitary facilities.
	 	4.1.43	Subsurface
    investigation.
	 	4.1.44	Water
    meter, sewer, and assessment fees
	 	4.1.45	Permanent
    fire extinguishers.
	 	4.1.46	Factory
    / Shop inspections and tests.
	 	4.1.47	Landscaping.
	 	4.1.48	X-ray
    tests on welds.
	 	4.1.49	Repair
    to existing insulation that is damaged prior to this work.
	 	4.1.50	Warranty
    or guarantee of existing systems.
	 	4.1.51	A
    crane hoist for service and maintenance will not be provided.


 


www.protecsinc.com


 




    	98



     


    

 


 


	 	V.	ESTIMATE



 


	 	VI.	COMMERCIAL
    TERMS


 


PROTECS
proposes to provide professional engineering and construction management services to implement the project as described herein for a
Guaranteed Maximum Price ($GMP) of Twenty Four Million Six Hundred Forty Eight Thousand Two Hundred Forty Eight Dollars ($24,648,248).
A breakdown for these costs in CSI format is provided within the attached estimate. This price is based on proceeding with the work in
accordance with the terms and conditions of the AIA 191 Part 2 Design/Build Agreement previously agreed to. Once this proposal is signed
an Exhibit will be provided to amend this proposal to the Agreement as indicated therein.


 


Work
can commence immediately upon receiving written authorization to proceed (i.e., a contract) or a purchase order and a ten (10%) percent
down payment. Our services will be invoiced monthly per the agreement and are payable net 20 days.


 


This
proposal is valid for a period of thirty (30) days from the date of the proposal. If the services of PROTECS do not commence, or are
stopped for a period of thirty (30) days through no act or fault of PROTECS, PROTECS may elect to renegotiate the terms of this agreement
to reflect changes in project scope, schedule, and fee schedules.


 


Any
changes made to this proposal do not constitute an agreement. All changes must be approved by both parties in writing. If you accept
this proposal, please sign one copy and return it to PROTECS.


 


	PROTECS	 	ACCEPTED
    BY:
	 	 	 
	PROPOSAL
    No. 1074PPA17.1 Rev. 1	 	Hemoglobin
    Oxygen Therapeutics, LLC.
	 	 	 
	Christopher
    R. DiPaolo	 	 
	 	 	 
	President	 	Date:	          


 


www.protecsinc.com


 




    	99



     


    

 


 


	 	VII.	MILESTONE
  SCHEDULE







 


	 	VIII.	ATTACHMENTS




 


	 	8.1	HbO2
    – Facility Expansion Documents List dated September 8, 2017 (9 Pages)
	 	 	 
	 	 	Note:
                                            Documents Previously Issued to HbO2 are indicated on the documents list, but are not attached.

    



 


	 	8.2	Site
    Logistics Plan dated July 19, 2017 (1 Page)


 


www.protecsinc.com


 




    	100



     


    

 


 


2017
Standard Terms and Conditions


Consulting
Services


 


This
document represents the standard terms and conditions for the PROTECS proposal to which this document is attached. These terms and conditions
shall apply to the work unless specifically stated otherwise in the clarification section or commercial terms section of the proposal.
These terms and conditions shall supersede blanket terms in seller/purchaser agreements, such as “the terms and conditions of this
purchase order or contract shall render all previous terms, conditions, etc. null and void”, unless the specific paragraphs of
this document are referenced. These terms and conditions shall also apply to authorizations issued by purchaser to seller on purchaser’s
letterhead and/or purchase order.


 





	
    1. CONTROLLING DOCUMENT The acceptance of Purchaser’s
    order is expressly made conditional on Purchaser’s assent to the terms and conditions set forth herein, and PROTECS (“Seller”)
    agrees to furnish the covered thereby only upon these terms and conditions. This document constitutes the entire agreement of the parties
    with respect to the subject matter hereof and supersedes all prior understandings and agreements. No term or condition of Purchaser’s
    order inconsistent with the terms and conditions hereof; and no term, condition, statement or representation not contained herein, shall
    be binding on Seller as a warranty or otherwise. No wavier, alteration, or modification of any of the provisions hereof, shall be binding
    on Seller unless made in writing signed by an officer of Seller.

     

    2. PRICES AND TAXES Prices shown are for delivery
    of goods/services, F.O.B. point of shipment. Any manufacturer’s tax, sales tax, use tax, excise tax, custom, inspection or testing
    fee, or any other tax, fee or charge of any nature whatsoever imposed by governmental authority, on or measured by the transaction between
    Seller and Purchaser shall be paid by Purchaser in addition to the prices quoted or invoiced. In the event Seller is required to pay any
    such tax, fee, or charge, Purchaser shall within ten (10) business days reimburse Seller therefore. Delinquent payments shall be subject
    to a carrying charge with interest terms below.

     

    3. TERMS AND METHOD OF PAYMENT Where Seller
    has extended credit to Purchaser, the terms of payment shall be net ten (10) days from date of invoice. RE: Services-Services will be
    invoiced on a percentage complete basis and are due upon receipt. Seller reserves the right to invoice on a periodic basis as required
    to facilitate the work. If, in the judgment of Seller, the financial condition of Purchaser at any time does not justify continuance of
    production of shipment upon the terms of payment specified, Seller may require full or partial payment in advance.

     

    4. DELIVERY AND DELAY Delivery of goods or
    services to a carrier at Seller’s plant or other loading point shall constitute delivery to Purchaser. Seller shall not be liable
    for any loss or damage as a result of any delay due to any cause beyond Seller’s control including, without limitation: an Act of
    God, act of Purchaser, fire, theft, accident, slowdown, strike, riot, embargo, governmental act, regulation or request, delays of common
    carriers, or other similar causes. In case of any such delay, the date of delivery shall be extended for a period equal to the time lost
    by cause of the delay. In no event shall Seller’s liability for any other delay exceed the sales price to Purchaser. Seller shall
    not be liable for any special, contingent, indirect or consequential damages (including anticipated profits) resulting from delay.

     

    5. STOP WORK OR CANCELLATION In the event of
    a request to stop work or to cancel the whole or part of any order, Purchaser shall pay Seller for: (a) Any and all work that has been
    completed. (b) For all other work in process and all materials and supplies procured or for which definite commitments have been made
    by Seller in connection with the order. Purchaser shall pay Seller all of Seller’s costs and expenses.

     

    6. TOOLING AND DESIGNS All specifications,
    drawings, designs, data, information, methods, descriptions, programs, software, software source code, ideas and/or inventions made, used,
    conceived, developed or acquired by Seller incident to its performance hereunder and all patent, trade-secret, know-how, copyright or
    other proprietary rights therein, shall be exclusive property of Seller and no part of the purchase price hereunder shall be deemed applicable
    to the foregoing items.

     

    7. INFRINGEMENT CLAIMS Proposals are offered
    for the sole and private use of Client’s name and is in response to solicitation for our services. The ideas, suggestions and intellectual
    contents remain the property of PROTECS and should not be shared with other unauthorized individuals or outside organizations without
    the written permission of PROTECS.
	 	
    Purchaser shall indemnify Seller for the costs of
    defending any suit or proceeding (including attorneys’ fees, witness fees, judgment or settlement) brought against Seller for infringement
    if the claimed infringement has resulted from Seller’s compliance with Purchaser’s designs, specifications, and instructions
    or by reason of the alterations, application or use of the goods by Purchaser or any other party.

     

    8. JURISDICTION LAW The agreement hereunder
    shall be governed by, and its terms constructed in accordance with, the laws of the State of Pennsylvania.

     

    9. ARBITRATION Any controversy or claim arising
    out of or relating to this Contract, or the breach thereof, shall be settled by arbitration held in Montgomery County, Pennsylvania, in
    accordance with the rules of the American Arbitration Association, and judgment upon the award rendered by the Arbitrator(s) may be entered
    in any Court having jurisdiction thereof.

     

    10. INTEREST Payments are due upon receipt
    unless noted otherwise in the commercial terms section of a Sellers proposal. Payments over thirty (30) days late shall accrue an interest
    charge at the rate of prime plus one percent. Prime is the prime interest rate as published in the Wall Street Journal on the first business
    day the payment is due and shall be adjustable on a monthly basis over the period the balance due remains an open seller receivable.

      

    11. ADDITIONAL SERVICES As time is of the essence
    situations/issues may arise where the Purchaser will require additional services not covered in Sellers proposal. Seller will provide
    these services on a time and material basis in accordance with Seller’s current published rate sheet. The additional services will
    be provided on a continuous basis so the impact to the project will be minimized. Approval of these services on the Purchasers behalf
    shall be considered tacit in nature. As completed Seller will issue a scope adjustment notice for record purposes only. Seller reserves
    the right to refrain from providing these additional services for any cause.

      

    12. HIRING In accepting or authorizing this
    proposal, Purchaser represents they will not hire Seller’s personnel, directly or indirectly, during the period Seller is performing
    services for Purchaser and for ninety (90) consecutive calendar days thereafter. Should Purchaser hire Seller’s personnel, direct
    or non-direct, Seller shall be entitled to a “Finders Fee” of 25% of the employee’s first year salary, payable in accordance
    with paragraph 3 upon the hire date of Seller’s employee by Purchaser.

      

    13. REIMBURSABLES Purchaser agrees to pay Seller
    for all reimbursable cost in addition to the fee addressed in the proposal. Reimbursable costs include but are not limited to travel,
    airfare, rail fare, car fees, meals; lodging, tolls, copies of documents and drawings, plots of documents and drawings, phone calls; photographs,
    etc. A 1.05 times multiplier will be added to the costs of the reimbursables.

     

    14.NON-SOLICITATION During the term of the
    contract with PROTECS, and for a period of one (1) year thereafter, the client shall not, directly or indirectly, without the prior written
    consent of the PROTECS, solicit or induce any employee or consultant of PROTECS to leave the employ or service of PROTECS or hire, retain,
    employ, or engage for any purpose any employee or consultant of PROTECS; however, such covenant shall be subject to PROTECS remaining
    in operation for the restrictive period defined hereunder. When PROTECS provides written consent, 25% finder’s fee will be charged
    to the client.






 


www.protecsinc.com


 




    	101