An Equal Opportunity Provider and Employer

VETERINARY SERVICES MEMORANDUM NO. 800.78

TO: Veterinary Services Executive Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants

FROM: Burke L. Healey

Deputy Administrator

SUBJECT: Preparation and Submission of Facilities Documents

I. PURPOSE

This memorandum provides guidance to firms on preparing and submitting facilities

documents to the Animal and Plant Health Inspection Service (APHIS) in order to meet 

the intent of the regulations, as specified in title 9, Code of Federal Regulations

(9 CFR), part 108, including the option of electronic submission of facility documents 

via the National Centers for Animal Health (NCAH) Portal. Facilities documents are 

one of the foundational requirements when applying for and maintaining a U.S. 

Veterinary Biologics Establishment License or U.S. Veterinary Biological Product 

Permit for Distribution and Sale.

II. CANCELLATION

This memorandum cancels Veterinary Services (VS) Memorandum No. 800.78 dated 

August 18, 2017.

III. BACKGROUND

Licensees and permittees should use the instructions provided by the regulations in 

9 CFR 108 to prepare, revise, and submit facilities documents. The Center for 

Veterinary Biologics (CVB) uses these documents, if the documents are correctly 

drafted, to determine if the facilities’ arrangement/design, functions described, and 

processes listed are adequate to allow for consistent preparation of product in 

accordance with the regulations and filed Outline of Production.

Licensees and permittees prepare veterinary biological products using various types of 

facilities, ranging from a single site and one building to multiple sites with many 

buildings per site. Facilities documents include the plot plan, the corresponding plot 

plan legend, the blueprint(s) and the corresponding blueprint legend(s), and any 

applicable appendices/addenda to the plot plan and/or blueprint legends. 

Through a thorough review process, CVB-Inspection and Compliance (IC) assesses 

each facilities document submission to ensure firms prepare biological products in 

Animal and Plant

Health Inspection

Service

Veterinary Services

1400 Independence

Ave, SW

Washington, DC

20250
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

facilities that meet the intent of the regulations, as outlined in 9 CFR 108. Examples of 

facilities document format are included as appendices to this memorandum.

IV. DEFINITIONS

A. Prepare or Preparation. Sometimes referred to as manufacture or produce; refers to 

the steps and procedures the firm uses in the manufacturing, processing, testing, 

packaging, labeling, and storing of a biological product, as described in 9 CFR 

101.2.

B. Production Facility. A location on licensed premises or foreign manufacturing sites

where the firm performs any step in preparing veterinary biological products.

C. Separate and Apart. A building or area on licensed premises that is physically and/or 

functionally distinct from the production facility, which the firm uses to effectively 

mitigate the possibility of cross-contaminating product from known and unknown 

sources.

If CVB considers a research facility/area to be separate and apart, CVB does not 

have to authorize the preparation of experimental biological products in that research 

facility/area, as described in 9 CFR 103.1.

CVB is implementing a similar practice for Quality Control (QC) areas that CVB 

considers to be separate and apart from the manufacturing area. For such QC areas, 

CVB will allow entities to continue to conduct serial release testing, but CVB will 

not require the entities to obtain CVB authorization to move experimental products, 

seeds, or cells into these areas for testing. The entity will be responsible for updating 

and submitting the list of fractions on an annual basis, or as requested by CVB, for 

these QC areas. CVB believes this new practice for QC areas should facilitate testing 

and may lead to a shorter submission time by the regulated entities in support of 

licensure. 

D. Fraction. A specific antigen, its antibodies, or its antitoxin that constitutes a 

component of a biological product. For the purpose of facilities documents and 

9 CFR 108, in addition to listing fractions, the firm should also list all live or 

inactivated organisms (whether or not they are used to prepare licensed product);

DNA, RNA, or proteins prepared as a component of final product; and infected and 

non-infected cell lines. For the rest of this memorandum, all items listed above will 

be referred to as “fractions.” CVB does not consider completed product in sealed,

final containers to be a fraction and does not require it to be listed for labeling and 

packaging areas.

E. Stationary Equipment. Equipment which the firm uses in the preparation of 

biological product (including testing) that is attached to the floor, wall, or ceiling of 

a room; that would require disassembly to remove from a room; or that would 
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

require validation, certification, or calibration after it was moved and prior to use. 

Examples include, but are not limited to, autoclaves and lyophilizers built into a 

wall, hard-ducted biological safety cabinets, and equipment supporting air and water 

quality used in production areas, such as high-efficiency particulate air (HEPA) filter 

banks and water for injection systems. 

F. Compartments. A controlled environment for which the firm uses air handling 

systems or other methods (such as a clean room) or specialized equipment (such as a 

laminar flow biosafety cabinet) to ensure protection of product and personnel and/or 

maintenance of adequate environmental conditions.

V. GENERAL GUIDANCE ON PREPARING FACILITIES DOCUMENTS

A. CVB requires that the firm include the following in facilities documents: 

1. The establishment/permittee name and number, as shown on the U.S. Veterinary 

Biologics Establishment license or the U.S. Veterinary Biological Product 

Permit, on each page of the submission.

2. The address of the facility or premises the document(s) pertain to, clearly 

identified on each page of the submission. This is particularly important for 

establishments with multiple site locations. 

3. Identification of the document on each page of the submission; e.g., ‘Blueprint 

for Building 1, 1st Floor’ or ‘Addendum A – List of Fractions.’ 

4. A page number on each legend and addendum page. CVB does not require page 

numbers on plot plan and blueprint drawings and does not require firms to 

include cover pages and tables of contents with the firm’s facilities document 

submissions.

5. The signature of a responsible firm official

a. Hardcopy submission, signature required on plot plans and blueprints. This

should be the liaison or an alternate liaison designated for the entity.

b. NCAH Portal Submission, a signature is not required due to the credentials 

required to access the NCAH Portal.

6. Assurance that adequate water, lighting, and drains exist in all areas. This can be 

accomplished by a single statement in the plot plan legend or blueprint legend.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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7. Legible documents. 

a. Hardcopy submission of plot plans and blueprints must be decipherable without 

the use of a magnifying glass. If needed, the plot plan and blueprint drawings 

may be on paper larger than standard size to ensure legibility. 

b. NCAH Portal Submission of plot plans and blueprints must also be legible. 

Scanned documents are not acceptable for electronic submission. 

8. The scale used for electronic plot plans and blueprints should be supplied in such 

a way as to accurately reflect the size of the buildings. This can be accomplished

several ways. Options include the following:

a. Supply a scale based on the proposed drawing size. For example, the scale is 

based on a 8x11 sheet of paper.

b. Bar measurements on the drawing that would enlarge or shrink with the 

drawing.

9. A 2-inch margin at the bottom of each document page to allow for the application 

of the VS file stamp.

B. Plot Plan and Plot Plan Legend

1. The firm must identify and include all buildings located on the licensed premises

on the plot plan, even if they are not used in the preparation of biological 

products.

2. If aerial photographs are used as a plot plan submission, they must meet all the 

requirements for a plot plan as described in 9 CFR 108.3.

3. The firm’s NCAH Portal Submission of the plot plan legend must be a pdf 

document generated from a word processing document. CVB will not accept 

scanned documents.

4. In the plot plan legend, the firm must list the function of each building shown on 

the plot plan. If a research or QC building is considered by CVB as separate and 

apart, the firm should clearly note the date of this approval in the plot plan 

legend as part of the description for the building function.

5. CVB allows the following addendums to be associated with the plot plan legend:

a. For entities with multiple sites, a description of the movement of biological 

material between licensed premises and the precautions taken to maintain 
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

proper storage conditions during transport. See VS Memorandum 800.87 for 

more information. 

b. A list of the location and condition of records storage at alternate locations 

(off-licensed premises) when authorized by CVB. In accordance with 9 CFR 

116.1(c), the firm is required to allow the inspection of these records by CVB. 

CVB may request these records for review during an on-site inspection. CVB 

provides additional guidance on electronic records stored at alternate locations

in VS Memorandum 800.122.

c. The firm must list the name and address of the off-site storage for portions of 

master seeds and master cells. CVB provides additional information in VS 

Memorandum 800.113.

Include reference to the CVB mail log number and the date of the authorization 

letter in the addendum.

C. Blueprint

1. Even if only a portion of the floor is used for biological production, the firm 

should show the same level of detail for the entire floor. However, if the 

establishment provides adequate processes that mitigate adverse impacts to the 

preparation of veterinary biologics as a part of the facility document, CVB-IC 

may provide an exemption to 9 CFR 108.4(c). Then the entity would not need to 

show stationary equipment, sinks, drains, etc. on the blueprints for these nonbiological process areas, but should list a general description regarding nonbiological production area functions in the blueprint legend; e.g., preparation of 

veterinary pharmaceuticals. 

2. The firm must identify all rooms shown on the blueprint by a letter or number 

that correlates with the identity of the room listed in the blueprint legend and at 

the establishment. This includes hallways, stairwells, closets, etc.

3. The firm must define all symbols and shapes on the blueprint; e.g., using a key on 

the blueprint or listed in the blueprint legend, and refrain from using those 

architectural-associated symbols or shapes which are inappropriate for blueprints 

submitted in accordance with 9 CFR 108.

4. The firm must show stationary equipment on the blueprint.

a. Firms may identify stationary equipment using the same identifier. For 

example, all autoclaves may be identified as “A” on the blueprints. The unique 

identification for each piece of equipment should not be included on the 

blueprint or listed in the blueprint legend. 
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

The intended purpose of the equipment may impact the code given. For 

instance, CVB does not consider a laminar flow clean bench to be the same 

equipment as a biological safety cabinet, since they function in different ways 

and are used for different purposes. Therefore, the firm would give the laminar 

flow clean bench and biological safety cabinet two distinct identifiers on the 

blueprint. 

c. Firms only need to show stationary equipment essential for the preparation of 

biological product. Displaying additional items (such as countertops, cabinets, 

shelves, etc.) might introduce unnecessary complexity to the submission. 

d. Firms should not show equipment that is not considered stationary on the 

blueprint.

5. The firm must show water outlets (e.g., sinks and floor drains) for rooms in which 

product is exposed to the surroundings.

6. As an alternative to an addendum describing other precautions against crosscontamination, the firm may submit a separate blueprint showing clean room 

classification, air pressure differentials, and areas served by specific HVAC units. 

Similarly, the firm may have a separate blueprint to document the locations for 

personnel, equipment, and product movement.

D. Blueprint Legend

1. CVB will only accept a NCAH Portal Submission of the blueprint legend if it is a 

pdf document generated from a word processing document. CVB will not accept 

scanned documents.

2. The firm must identify all rooms, clearly state the function(s) of these rooms and 

avoid vague room function/use descriptions such as “laboratory,” “storage,” 

“production,” etc. For example, the the firm must provide a description of a 

production room which identifies what production steps occur in that room and 

must clearly identify the rooms used for both research and development (R&D)

and licensed product preparation.

3. If CVB identifies a research or QC area(s) within a building as separate and apart, 

the firm must clearly document the date of CVB’s approval and the mail log 

number (if applicable) in the blueprint legend as part of the description for the 

room functions.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

4. If CVB identifies a non-biological production area(s) described in the blueprint 

legend as separate and apart from biological production, then the firm is only 

required to provide a description of the room functions and may omit additional 

details which CVB would require for areas that are not separate and apart from 

biological production. 

An example is the manufacturing of pharmaceuticals in the same building as 

biologics. The firm lists the general function of the pharmaceutical production 

area and applicable room numbers in the blueprint legend as shown on the 

blueprint and describes the controls used to ensure biological product quality. See 

section V.C.1.

Note: Biological production and non-biological production are not the same as 

licensed biological production and unlicensed biological production, respectively. 

If biologics produced under the Food and Drug Administration-Export Reform 

and Enhancement Act (FDA-EREA) and/or within R&D are prepared in the same 

building as licensed biologics, the firm is required to provide the same level of 

detail for all areas.

5. Firms must clearly identify rooms in which product and raw materials are 

exposed to the surroundings in the blueprint legend or on the blueprint itself in 

order for CVB to determine if the processes used to mitigate cross-contamination 

are adequate. This includes all rooms or compartments where product might be 

manipulated outside of a closed system.

6. The firm must identify stationary equipment located in the room in the blueprint 

legend, unless the items are sufficiently described on the blueprint, and list other 

essential (non-stationary) equipment used for product preparation within the 

room. CVB, in particular, requires that the firm clearly note if equipment 

produces aerosols, such as, but not limited to, sonicators and centrifuges.

7. The firm must clearly link any addendums associated with the blueprint legends 

to a specific room. The firm may place information that is repetitive across 

several rooms, such as lists of fractions or equipment and other precautions 

against cross contamination of product, etc., at the end of the blueprint legend as 

an addendum. The firm must provide a reference to one or more of these 

addendums for each applicable room listed in the blueprint legend, but the firm 

should not list or include standard operating procedures.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

The firm must include the following, as applicable, in blueprint legend 

addendums :

a. Methods used to Mitigate Contamination of Product. This requirement is 

particularly applicable to the processes used in rooms in which product or raw 

materials are exposed to the surroundings.

(1) Decontamination procedures. The firm must use cleaning and disinfection 

methods that CVB accepts as appropriate for the fractions used and the 

processes performed, and the firm must:

Identify the disinfectant by chemical type and not just by the trade 

name. CVB uses this information to determine the antimicrobial 

properties. Document the frequency of the process in specific terms. 

For example, CVB might accept “as needed, but at least after every 

use” as adequate, but CVB will not accept terms that do not provide 

sufficient information to determine the appropriateness of the 

process, such as “as needed” or “on a routine basis.” 

(2) Other precautions against cross contamination. The firm must use 

essential processes, as determined by CVB, beyond the decontamination 

procedures to mitigate contamination of the product. The firm must 

include the following items, as applicable, in a blueprint legend

addendum:

• Entry and exit procedures for personnel, equipment, and materials. For 

example, gowning procedures within an area remotely located from a 

production room; e.g., changing into scrubs upon entry into a 

production building 

• Room/Area access

• Campaign manufacturing. Defined as working with only one fraction 

at a time within a production room

• Environmental monitoring

• Clean room classification, room air pressure differentials, and 

dedicated HVAC units with HEPA filtered air supply and/or exhaust 

shown on a blueprint drawing

• Personnel, equipment, and product movement (may be shown on a 

blueprint drawing)

• Drainage and plumbing systems. Function to prevent effluent 

backflow into critical production rooms. Drainage lines can be 

decontaminated
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

b. Fractions List(s). See section IV.D.

(1) CVB considers all fractions, including, but not limited to, bacterial, 

viral, fungal, parasitic, and prion agent fractions listed in the facility 

documents to be live agents, unless the firm clearly states otherwise.

(2) Include only those fractions routinely prepared in a room at the facility 

for which the documents are being submitted. CVB prefers that the firm 

refrain from listing any and all fractions that may ever possibly be used 

in a room. CVB requires the firm to update the fraction listing on a 

regular basis; however, CVB does not require immediate updating of 

the fraction listing whenever a new fraction is obtained.

(3) For QC and R&D rooms, the firm may have a broader list of fractions.

(4) The firm should not refer to fractions as “approved.” The purpose for 

listing fractions in the facilities document is to provide information that 

CVB uses to determine if the facilities, equipment, and processes are 

appropriate to mitigate contamination, not to confirm the CVB-Policy, 

Evaluation, and Licensing’s authorization to introduce an organism into 

the production facility. 

(5) The firm cannot simply list fractions in the facilities documents in lieu 

of completing the CVB-required process to request permission to 

prepare experimental biological product in a production facility in 

accordance with 9 CFR 103.1.

c. Exemptions to 9 CFR 109, Sterilization of Equipment

(1) The firm must not use sterilization methods other than those listed in 9 

CFR 109.1 for containers, instruments, and equipment that come into

contact with product, unless CVB has granted an exemption for the 

firm to use these methods. The exemption listing should include the 

following:

• Listing of containers, instruments, and/or equipment

• Method of sterilization/sanitation used 

o Time

o Temperatures

o Exposure ranges; e.g., irradiation processes reported in kilograys 

or other validated assurance levels

o Sanitation methods; e.g., fractionation columns

• The firm must provide a statement indicating records supporting 

verification/validation of the method are on file at the establishment. 
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

Depending on the proposed sterilization method, CVB may request 

additional information.

• System of recordkeeping for the alternative method

(2) The firm shall equip steam and dry-heat sterilizers with automatic 

recording gauges. CVB requires an exemption to 9 CFR 109.2 if a firm 

has older equipment or smaller equipment that does not have automatic 

recording gauges. In the exemption listing, the firm must include the 

alternative method of recordkeeping for critical parameters required for 

sterilization. 

8. In order to minimize the number of pages in a blueprint legend submission, CVB 

prefers the firm to maximize the information listed per page and avoid partially 

blank pages resulting from listing only one room per page. 

E. Revision of Facilities Documents

1. Facilities documents should be reviewed on a regular basis (e.g., annually) and 

revised when changes occur to the facilities and/or procedures described in the 

facilities documents that may impact the preparation of licensed product. This 

includes additions to or deletions from the ‘Fractions’ list.

2. A summary of changes

a. For hardcopy submissions, CVB requires the firm to provide a summary of 

changes with each revision of facilities documents.

b. For NCAH Portal Submissions, CVB requires the firm to provide a summary of 

changes for:

(1) Each plot plan and blueprint, including a list of changes made and why 

for major construction changes.

(2) The first electronic submission of the legends and addenda. Subsequent 

updates submitted electronically no longer require summary of changes.

c. CVB recommends, but does not require, that the firm place a supersedes date 

on each page.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

F. Preliminary Documents

Licensees, permittees, and applicants may submit preliminary drawings for comment 

before construction of new facilities, when the company anticipates renovation of 

existing facilities, or when other facility changes will affect workflow. CVB will file, 

rather than approve, the preliminary facilities documents and will maintain them for 

future reference. CVB may require an inspection of new construction or renovation of 

facilities prior to product preparation in these areas. 

G. Submission of Facilities Documents

1. Hard Copy 

a. Prior to submission, personnel familiar with the regulations and guidance 

documents pertaining to facility documents should review the submission for 

adequacy and completion. This is a critical step in reducing the amount of 

preparation and review time required by both the firm and CVB.

b. CVB will stamp acceptable submissions as filed. CVB will return one stamped 

copy to the submitter and file one copy. CVB may return facilities document 

submissions requiring revision as unprocessed, with a request for the licensed, 

permitted, or applying establishment to resubmit the documents to CVB after 

the necessary revisions have been made.

c. Licensees and permittees should submit two copies of the facilities documents 

to the Center for Veterinary Biologics-Inspection and Compliance, 1920 

Dayton Avenue, P.O. Box 844, Ames, IA 50010.

d. If it is submitting more than two copies of the facilities documents, the firm 

should explain why this is necessary in a cover letter.

2. NCAH Portal Submissions

 a. Prior to submission, personnel familiar with the regulations and guidance 

documents pertaining to facility documents should review the submission for 

adequacy and completion. This is a critical step in reducing the amount of

preparation and review time required by both the firm and CVB.

 b. CVB will stamp acceptable submissions as filed. CVB may include a request 

for revisions with the stamped facility documents; CVB expects these revisions 

to be addressed at the manufacturer’s next annual review.

 c. Licensees and permittees should follow NCAH Portal User Guides 9 and 26 

when submitting facility documents electronically. NCAH Portal User Guides 

are available on the CVB website.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

H. Examples of Facilities Documents

There are examples for each type of facility document typically found in a complete 

facilities document submission in the appendices to this memorandum. CVB intends 

for these examples to be used in conjunction with the regulations listed in 9 CFR 108

and guidance in VS Memorandum 800.78. CVB does not intend for these examples 

to address all of the requirements associated with preparing facilities documents or 

to be templates. 

Appendices

Pursuant to the Congressional Review Act (5 U.S.C. § 801 et seq.), the Office of 

Information and Regulatory Affairs designated this rule as a non-major rule, as 

defined by 5 U.S.C. § 804(2).
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

Appendix I: Plot Plan (example)
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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Appendix II: Plot Plan Legend (example)

Page 1

Best Biologics 1234 Coastal Highway

Establishment 2468 Anywhere, Texas 

Building 1 

Function: Preparation of viral veterinary biological products.

Construction Materials: Steel frame with exterior walls composed of concrete panels with a 

metal roof. Interior walls are epoxy painted concrete block or drywall or fiberglass reinforced 

paneling. Ceilings are epoxy-painted drywall. Floors are poured epoxy over concrete. 

Building 2

Function: Small animal building used for QC testing of veterinary biological products.

Construction Materials: Steel frame with exterior walls composed of concrete panels with a 

metal roof. Interior walls are epoxy paint over concrete block. Ceilings are epoxy-painted 

drywall. Floors are poured epoxy over concrete. 

Note: This building is considered separate and apart from production. See the CVB 

authorization letter dated January 22, 2017 (ML 123456). 

Building 3

Function: Administrative Offices (records regarding the preparation of licensed product are 

maintained here).

Building 4

Function: Preparation of bacterial veterinary biological products, QC testing, and R&D.

Construction Materials: Steel frame with exterior walls composed of concrete panels with a 

metal roof. Interior walls are epoxy-painted concrete block or drywall or fiberglass 

reinforced paneling. Ceilings are epoxy-painted drywall. Floors are poured epoxy over 

concrete. 

Building 5

Function: Warehouse, packaging and labeling

Construction Materials: Steel frame with metal siding and a metal roof. Interior walls and 

ceilings are epoxy-painted drywall. Floors are sealed concrete.

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

Appendix II (continued): Plot Plan Legend (example)

Page 2

Best Biologics 1234 Coastal Highway

Establishment 2468 Anywhere, Texas 

Building 6

Function: Maintenance Shop

Water, Drainage, and Lighting – Adequate water, drains, and lighting exist in all rooms* 

used in the preparation of veterinary biological product. 

*Some rooms do not require water and/or drains.

Examples of buildings requiring blueprints:

Manufacturing 

Shipping – Distribution 

Testing, including animal facilities

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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Appendix III: Plot Plan Legend, Addendum 1

Storage of Master Seed Off Licensed Premises (example)

Page 1

Best Biologics 1234 Coastal Highway

Establishment 2468 Anywhere, Texas 

In addition to the master seed organisms stored on Best Biologics licensed premises, 

additional quantities of these master seed organisms will be stored at the following:

A-1 Cold Storage

5678 Mountain Top Road

Somewhere, Colorado

Telephone: 777-888-9999

The management at A-1 storage has provided Best Biologics with written assurance that this 

off-site location may be inspected by APHIS inspectors. See the CVB authorization letter 

dated January 22, 2017 (ML 000000). 

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

Appendix IV: Blueprint - Building 1, Viral Suite (example)*

* For illustration purposes, this example only shows a portion of the production area, not the 

entire Building 1 floorspace. The expectation would be to have the entire floor of the 

building shown on the blueprint.

 
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

Appendix V: Blueprint Legend - Building 1, Viral Suite (example)*

* For illustration purposes this example only describes a portion of the production area, not 

the entire Building 1 floor. The expectation would be to have a description of the entire floor 

in the actual blueprint legend.

Page 1 of 4

Best Biologics 1234 Coastal Highway

Establishment 2468 Anywhere, Texas 

 

Room 1

Function: Material & Supply Entry 

Equipment:

Coded Stationary Equipment: Autoclave (A) 

Fractions: NA

Room Management: Addendum B, Section I 

Room 2

Function: Storage for Clean/Sterile Production Equipment & Supplies 

Equipment:

Coded Stationary Equipment: Autoclave (A) 

Non-stationary equipment: filling equipment, lyophilizer trays & racks

Fractions: NA

Room Management: NA

Room 3

Function: Production Equipment Cleaning and Preparation 

Equipment:

Coded Stationary Equipment: Double bin sink (S) 

Fractions: NA

Room Management: Addendum B, Section I

Room 4

Function: Walk-in Cooler – Storage of Completed Product in Bulk and Final Container 

Equipment:

Non-stationary equipment: Fill tanks

Fractions: See Addendum A, Section A

Room Management: NA

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

Appendix V (continued): Blueprint Legend - Building 1, Viral Suite (example)

Page 2 of 4

Best Biologics 1234 Coastal Highway

Establishment 2468 Anywhere, Texas 

Room 4a

Function: Storage of APHIS Retention & QC Samples 

Equipment: NA

Fractions: NA 

Room Management: Chain link enclosure with secure entry

Room 5

Function: Hallway 

Equipment: NA

Fractions: NA 

Room Management: NA

Room 5a

Function: Product, Equipment, Material Airlock

Equipment: NA

Fractions: NA 

Room Management: NA

Room 6 

Function: Capping, Packaging, and Labeling of Lyophilized Product

Equipment: 

Coded stationary equipment – Packaging/Labeling Line (Z); Capping machine (CM)

Non-stationary equipment – Portable and secure label storage cages; product transfer carts

Fractions: NA

Room Management: Addendum B, Section I 

Room 7 

Function: Product Transfer Airlock 

Equipment: NA

Fractions: NA

Room Management: Addendum B, Section I

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example. 
VETERINARY SERVICES MEMORANDUM NO. 800.78 

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 An Equal Opportunity Provider and Employer

Appendix V (continued): Blueprint Legend - Building 1, Viral Suite (example)

Page 3 of 4

Best Biologics 1234 Coastal Highway

Establishment 2468 Anywhere, Texas 

Room 8 

Function: Lyophilization of Viral Products

Equipment: 

Coded stationary equipment – Freeze Dryers (C)

Non-stationary equipment – Trays and racks for loading and transporting vials to be freeze 

dried; hand seal crimper

Fractions: See Addendum A, Section A

Room Management: Addendum B, Sections II & III 

Room 8a

Function: Personnel Airlock 

Equipment: NA

Fractions: NA

Room Management: Addendum B, Section I; Addendum C, Section II 

Room 9

Function: Product Transfer Airlock 

Equipment: NA

Fractions: NA

Room Management: Addendum B, Sections II (a-c) & III

Room 10

Function: Fill Room for Lyophilized Viral Products 

Equipment: 

Coded Stationary Equipment – Fill machine (B), Clean room (...)

Non-stationary equipment – Table top scale, transport rack for vials, intermediate-fill tank 

Fractions: See Addendum A, Section A 

Room Management: See Addendum B, Sections II & III; Addendum C, Section III 

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp. 

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example. 
VETERINARY SERVICES MEMORANDUM NO. 800.78 

Page 21

 An Equal Opportunity Provider and Employer

Appendix V (continued): Blueprint Legend - Building 1, Viral Suite (example)

Page 4 of 4

Best Biologics 1234 Coastal Highway

Establishment 2468 Anywhere, Texas 

Room 11

Function: Fill Tank Room

Equipment: 

Non-stationary equipment: Fill tank

Fractions: See Addendum A, Section A

Room Management: Addendum B, Section I

Room 12 

Function: Equipment and Supply Airlock 

Equipment: NA

Fractions: NA

Room Management: Addendum B, Section I

Room 13

Function: Personnel Airlock 

Equipment: NA

Fractions: NA

Room Management: Addendum B, Section I; Addendum C, Section III.a

Room 14

Function: Viral Production Primary Personnel Airlock 

Equipment: NA

Fractions: NA

Room Management: Addendum B, Section I

Room 15

Function: Women’s Locker Room/Rest Room

Equipment: NA

Fractions: NA

Room Management: Addendum C, Section I 

Room 16

Function: Men’s Locker Room/Rest Room 

Equipment: NA

Fractions: NA

Room Management: Addendum C, Section I

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

Page 22

 An Equal Opportunity Provider and Employer

Appendix VI: Blueprint Legend - Building 1, Addendum A

Listing of Fractions (example)

Page 1 

Best Biologics 1234 Coastal Highway

Establishment 2468 Anywhere, Texas

A. Viral Fractions B. Bacterial Fractions

Bovine Rhinotracheitis Virus Actinobacillus pleuropneumoniae

Bovine Respiratory Syncytial Virus Bordetella bronchiseptica

Parainfluenza3 Virus Mannheimia haemolytica

Canine Distemper Virus Pasteurella multocida

Canine Parvovirus Campylobacter fetus

Canine Coronavirus Clostridium chauvoei

Equine Herpesvirus, Type 3 Clostridium septicum

Equine Herpesvirus, Type 4 Haemophilus somnus

Equine Influenza Virus Haemophilus parasuis

West Nile Virus Leptospira canicola

Leptospira hardjo

Leptospira icterohaemorrhagiae

Leptospira pomona

C. Production Cell Lines

Madin-Darby Bovine Kidney 

Dog Kidney 

Vero

D. Organisms for Quality Control Use Only

Bacillus subtilis

Candida albicans

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

Page 23

 An Equal Opportunity Provider and Employer

Appendix VII: Blueprint Legend - Building 1, Addendum B

Viral Suite - Decontamination Procedures (example)

Page 1 of 1

Best Biologics 1234 Coastal Highway

Est 2468 Anywhere, Texas

 

Section I. Applicable to all production areas:

a. Floors are mopped with a phenolic disinfectant solution at the end of each shift/daily.

b. Walls are cleaned with a phenolic disinfectant solution weekly.

c. Ceilings are cleaned with a phenolic disinfectant solution quarterly.

d. Room 1 only - Items entering into Room 1 are steam sterilized or are sprayed with a 

phenolic disinfectant solution and held for 20 minutes prior to exiting the room.

e. Room 6 only - The capping machine and packaging line are cleaned with sodium 

hypochlorite disinfectant wipes after each serial is sealed/packaged.

Section II. Applicable to production rooms in which product is exposed to the surroundings:

a. All work surfaces, including biological safety cabinet, are cleaned after each 

operation with 70% Isopropyl alcohol.

b. Floors are cleaned after each operation with a phenolic disinfectant solution.

c. Walls and ceilings are cleaned with a phenolic disinfectant solution weekly.

d. Equipment, containers, instruments, and materials are placed in the airlock for the 

room and sprayed with a phenolic disinfectant solution and held for 20 minutes prior 

to moving into and or out of the production room.

Section III. Movement of equipment and material from rooms where product is exposed to 

the surroundings:

a. Removable equipment items are bagged and sprayed with 70% Isopropyl alcohol. 

b. Waste is double bagged and the outer bag is sprayed with 70% Isopropyl alcohol 

prior to exiting the room.

c. Contaminated waste is chemically sterilized or disinfected prior to final disposal.

d. Room 8 only: Lyophilizer –Vial trays and lyophilizer shelves are wiped with a 

phenolic disinfectant solution. A steam-in-place (SIP) procedure is performed on the 

inside of each lyophilizer unit after each serial is freeze dried. 

e. Room 10 only: Fill line – Removable parts are cleaned and steam sterilized. The rest 

of the line and associated clean room is wiped with a phenolic disinfectant solution 

prior to and after each serial is filled. 

Disinfectants used include: sodium hypochlorite, phenolic agents, 70% Isopropyl alcohol, 

and peracetic/acetic acid hydrogen peroxide. Sodium hypochlorite disinfectant wipes may 

also be used for surfaces. 

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

Page 24

 An Equal Opportunity Provider and Employer

Appendix VIII: Blueprint Legend - Building 1, Addendum C

Viral Suite - Other Precautions Against Cross Contamination (example)

Page 1of 1

Best Biologics 1234 Coastal Highway

Est 2468 Anywhere, Texas

Section I. Applicable to Building 1 Entry:

a. Access to the Viral Suite is limited to authorized personnel.

b. Employees and visitors change into scrubs, put on a bouffant cap, beard cover (if

applicable), safety glasses, and shoe covers. Hands are washed and a sanitizing foam is 

used. 

Section II. Additional precautions taken for working in Lyophilization Room 8:

Secondary gowning occurs prior to entry into Room 8, which includes donning a lab coat, 

surgical mask, gloves, and shoe covers. Secondary gowning is removed and hands are 

washed and/or hand sanitizer is used prior to exiting the production room.

Section III. Additional precautions taken for working in Fill Room 10 and 

Clean Room 10a.

a. Full body sterile suit including gown, hood, and booties; mask; two pairs of gloves, 

and safety glasses are donned prior to entry into Room 10. Secondary gowning is 

removed and hands are washed and/or hand sanitizer is used prior to exiting the 

Production Room.

b. Open manipulation of product is performed inside a positive pressure HEPA-filtered 

Clean Room. 

c. Environmental monitoring is performed during filling with alert and alarm levels 

determined to demonstrate effectiveness of processes to mitigate cross-contamination 

of product. Media fills are performed quarterly.

Section IV. Additional precautions against cross contamination may be shown using a 

specialized blueprint drawing such as Appendix IX – Building 1 HVAC/Airflow Blueprint.

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

Page 25

 An Equal Opportunity Provider and Employer

Appendix IX: Building 1- HVAC/Airflow Blueprint (example)*

* For illustration purposes, this example only shows a portion of the production area, not the 

entire Building 1 floorspace. The expectation would be to have the entire floor of the 

building shown on the blueprint.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

Page 26

 An Equal Opportunity Provider and Employer

Appendix X: Blueprint Legend - Building 1, Addendum D

Viral Suite - Items Exempted from the Requirements of

9 CFR 109.1 and/or 109.2 (example)

Page 1

Best Biologics 1234 Coastal Highway

Est 2468 Anywhere, Texas

 

The following equipment is exempted from the sterilization requirements in 9 CFR 109.1:

I. Glass vials used for bottling final product 

A. Method of Sterilization

 Vaccine bottles are sterilized by gamma irradiation at 30 kGy by the supplier.

B. Documentation

1. Certificate of sterility provided by the supplier is maintained by Quality Assurance. 

2. Each production record contains the lot number for the bottles used in serial 

 preparation.

II. Rubber stoppers for vials of product

A. Method of Sterilization

Rubber stoppers are sterilized by gamma irradiation at 30 kGy by the supplier.

B. Documentation

1. Certificate of sterility provided by the supplier is maintained by Quality Assurance. 

2. Each production record contains the lot number for the stoppers used in serial

 preparation.

Records supporting verification/validation of the sterilization method described above are on 

file.

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.
VETERINARY SERVICES MEMORANDUM NO. 800.78 

Page 27

 An Equal Opportunity Provider and Employer

Appendix X (continued): Blueprint Legend - Building 1, Addendum D

Viral Suite - Items Exempted from the Requirements of

9 CFR 109.1 and/or 109.2 (example)

Page 2

Best Biologics 1234 Coastal Highway

Est 2468 Anywhere, Texas

The following equipment is exempted from the sterilizer recordkeeping system requirements 

specified in 9 CFR 109.2:

Stainless Steel Fill Tanks

A. Method of Sterilization

Tanks are steam sterilized in place (SIP) through a steam line in Room 4 for a 

minimum of 90 minutes at 121 o

C. Temperature is verified visually by using a 

calibrated in-tank thermometer. Once 121 oC is achieved, this is the start time. 

Temperature readings are taken every 15 minutes with a final reading taken at 

90 minutes.

B. Documentation

All SIP time and temperature readings are recorded in the SIP log in Room 4. The 

operator confirms the run time and temperature of the SIP for the tank along with the 

SIP run number in the appropriate space on the tank tag. The tag is subsequently 

placed into the production record. All records are authenticated and dated.

Signed:

______________________________________________________

Date:

______________

Printed name and title:

______________________________________________________

Leave a 2-inch margin at the bottom of the page to allow for the VS file stamp.

Note: The content of this Appendix does not constitute endorsement by APHIS of the facilities, methods, or 

procedures represented in this example.