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Timestamp: 2013-05-20 01:58:47
Document Index: 224036293

Matched Legal Cases: ['arts 38', 'arts 38', 'art 38', 'arts 38', 'arts 38', 'art 416', 'art 416', 'art 416']

Mobile Filtration Facility And Methods Of Use 13 views for this patent on FreshPatents.comupdated 05/17/13
Patents sorted by company.	08/16/07 | Class 210 Monitor | RSS | Browse: Prev - Next Mobile filtration facility and methods of use Abstract: A mobile first housing bounds a substantially sterile clean room, a filtration room, and at least one change room communicating between clean room. A fluid filtration system is disposed within the first housing, the filtration system includes a first support container in which a disposable fill bag is disposed. A disposable fluid line extends between the fill bag and the at least one filter. A support bin is also disposed within the first housing. A disposable pooling bag is disposed within the support bin, the pooling bag being in fluid communication with the at least one filter. A disposable fill line has a first end in fluid communication with the pooling bag and an opposing second end disposed within the clean room. ...
Agent: Workman Nydegger (f/k/a Workman Nydegger & Seeley) - Salt Lake City, UT, USInventors: Gary H. Graetz, Tracy ZillesUSPTO Applicaton #: #20070187317 - Class: 210321600 (USPTO) - 08/16/07 - Class 210 Related Terms: Clean Room Related Patent Categories: Liquid Purification Or Separation, Casing Divided By Membrane Into Sections Having Inlet(s) And/or Outlet(s)The Patent Description & Claims data below is from USPTO Patent Application 20070187317, Mobile filtration facility and methods of use.Clean Room BACKGROUND OF THE INVENTION
[0002] The present invention relates to mobile filtration facilities used
in filtering liquids derived from mammalian blood and other fluids.
[0003] 2. The Relevant Technology
[0004] Mammalian blood serum, such as fetal bovine serum, calf serum, and
the blood serum of other mammals, is broadly used in the growth and
development of cell cultures. Although serum can be derived from the
blood of all animals, it has been found that serum derived from a fetus
or new born has enhanced properties for cell growth. In part, this is
because such serums are high in growth factors and hormones which enhance
[0005] Most mammalian blood serum is obtained at established
slaughterhouses. For example, fetal bovine serum is typically obtained
from fetuses that are removed from cattle that are slaughtered for beef.
The fetuses are taken to an area of the slaughterhouse where the blood is
harvested from the fetuses. The blood is then processed so as to remove
the serum component. The raw unfiltered serum is then placed in bottles
and quickly frozen.
[0006] Because there are relatively few fetuses and such fetuses have a
rather small amount of blood, fetal bovine serum is a precious and
expensive commodity. Prior to use of the serum, the serum must be
filtered under highly stringent conditions that require the use of a
sterile clean room. Furthermore, most filtering processes pass the serum
through different stainless steel tanks and fixed lines that must be
repeatedly cleaned and certified between batches. This cleaning requires
the use and disposal of hazardous cleaning chemicals. Although a clean
room and the required filtering equipment can be erected at each
slaughterhouse, this is generally not cost efficient. That is, because
there is such a small volume of fetal bovine serum harvested at a given
slaughterhouse, it is difficult for a single slaughterhouse to recoup the
expense of building, operating, manning, and maintaining a sterile clean
room and the filtration equipment.
[0007] As a result, the traditional approach to filtering serum is to ship
the serum to an established filtration facility. The problem with this
approach, however, is that slaughterhouses are widely spaced apart
throughout the world and there are relatively few filtration facilities.
Because serum must remain frozen, the serum becomes relatively expensive
to ship over long distances to the established filtration facilities.
Furthermore, because of various blood diseases, some countries will not
allow blood products to be transported into their country for filtering
and/or sale.
[0008] In addition, it is often critically important to the purchasers of
filtered serum that they can establish and certify where a particular
serum was derived and filtered. Acquiring a serum in one country,
filtering the serum in a second country, and then attempting to sell the
serum in a third country is largely prohibitive. Such movement between
countries makes is difficult to obtain required import licenses and to
provide sufficient assurance to the end purchasers as to the origin and
history of the serum.
[0009] Similar types of problems are also encountered in filtering blood
components which are used in clinical chemistry controls. For example,
human donated blood that has expired is typically processed to extract
the serum, plasma, and fractions thereof which can subsequently be used
in clinical chemistry controls. Again, prior to use such blood components
must be filtered under highly stringent conditions that require the use
of a sterile clean room and a filtration system. The expired blood is
often found at blood banks and other storage facilities located at
sporadic locations throughout the world. As with fetal bovine serum,
filtering the blood components is cost prohibitive to the storage
facilities. The blood and/or bloods products are thus typically shipped
to filtration facilities. Again, however, the shipping of blood products
requires refrigerated shipping which adds significant cost to the final
blood products. Furthermore, attempts to transport blood products between
different countries can be problematic.
[0010] Accordingly, what is needed are methods and systems that can be
used to efficiently filter and/or sterilize blood products and other
types of liquids that are produced and/or collected at different
[0011] Various embodiments of the present invention will now be discussed
with reference to the appended drawings. It is appreciated that these
drawings depict only typical embodiments of the invention and are
therefore not to be considered limiting of its scope.
[0012] FIG. 1 is a perspective view of a filtration facility including a
first housing and a second housing;
[0013] FIG. 2 is a top cross sectional plan view of the first housing
[0014] FIG. 3 is a top cross sectional plan view of the second housing
[0015] FIG. 4 is a front view of a filtration system disposed within the
second housing shown in FIG. 3;
[0016] FIG. 5 is cross sectional side view of a fill container assembly of
the filtration system shown in FIG. 4;
[0017] FIG. 6 is a perspective view of a pooling bag assembly of the
filtration system shown in FIG. 4;
[0018] FIG. 7 is a partially exploded perspective view of a pooling bag of
the pooling bag assembly shown in FIG. 6;
[0019] FIG. 8 is a cross sectional side view showing a connection of a dip
tube to the pooling bag shown in FIG. 6;
[0020] FIG. 9 is a partial cross sectional top plan view of a fill line
assembly of the pooling bag assembly shown in FIG. 6;
[0021] FIG. 10 is a top plan view of the pooling bag assembly shown in
FIG. 6 in a collapsed state and sealed within double bags;
[0022] FIG. 11 is a perspective view of a support bin of the filtration
system shown in FIG. 4;
[0023] FIG. 12 is a partially disassembled top plan view of the support
bin shown in FIG. 11;
[0024] FIG. 13 is a partially disassembled bottom perspective view of the
support bin shown in FIG. 11;
[0025] FIG. 14 is an elevated front view of a bracket shown in FIG. 13;
[0026] FIG. 15 is a perspective view of a retention plate of the support
[0027] FIG. 16 is a bottom perspective view of the support bin shown in
FIG. 11 with the door removed; and
[0028] FIG. 17 is a front view of the pooling container assembly shown in
FIG. 4 used in dispensing a liquid into bottles within the clean room of
the second housing shown in FIG. 3.
[0029] The present invention relates to mobile filtration facilities and
methods of use. In one embodiment the mobile filtration facilities can be
used in the filtration and/or sterilization of mammalian blood components
such as serum, plasma, and fractions thereof. Such blood components can
be derived from human and non-human mammals. For example, as used in the
specification and appended claims, the term "mammalian blood serum" is
broadly intended to include fetal bovine serum, calf serum, and the blood
serum of other mammals such as horses, pigs, sheep, and the like.
Mammalian blood serum can also comprise serum derived from donated human
blood. In alternative embodiments, the mobile filtration facilities can
be used in the filtration and/or sterilization of media, buffers, and
regents used in the growth of cell cultures and in still other liquids
which require filtration and/or sterilization.
[0030] Depicted in FIG. 1 is one embodiment of an inventive mobile
filtration facility 8 incorporating features of the present invention.
Filtration facility 8 comprises a mobile first housing 10 and a mobile
second housing 12. Each housing 10 and 12 has a substantially
parallelepiped configuration that includes a front wall 14 and an
opposing back wall 16 that each extend between a first end wall 18 and an
opposing second end wall 20. Each housing 10 and 12 also includes a flat
roof 22 and a floor 24. Hooking ports 26 are formed on each corner of
each housing 10 and 12 to facilitate attachment to housings 10 and 12 for
[0031] In one embodiment, each of first housing 10 and second housing 12
comprises a standard metal shipping container having standard dimensions.
For example, containers intended for intercontinental use typically have
external standard dimensions of length 20 feet (6.10 m), 30 feet (9.14
m), or 40 feet (12.20 m); width of 8 feet (2.44 m); and height of 8.5
feet (2.59 m) or 9.5 feet (2.90 m). These dimensions are only
approximations and can vary within a few inches. For example, the 30 feet
containers are typically closer to 29.9375 feet (9.125 m) in length.
Other standard and non-standard dimensions can also be used. In the
illustrated example of the present invention, each of first housing 10
and second housing 12 has a length of 40 feet (12.20 m), a width of 8
feet (2.44 m), and height between 8.5 feet (2.59 m) to 9.5 feet (2.90 m)
each within a tolerance of a few inches, such as within six inches (0.15
[0032] By forming the filtration facility 8 out of standard shipping
containers, housings 10 and 12 can be stacked, if desired, and easily
transported by rail, ship, truck or the like using conventional
techniques. In an alternative embodiment, housings 10 and 12 can be
custom designed having other dimensions. In such other embodiments, roof
22 can be pitched.
[0033] As depicted in FIGS. 1 and 2, first housing 10 comprises a thaw
room 26 and a quick freezer room 28. A storage room 30 houses the heating
and ventilation equipment that regulates the air flow and temperature
within thaw room 26 while a storage room 32 houses the compressor and
other equipment 31 needed to control the temperature within freezer room
[0034] Thaw room 26 is accessed through a door 33 and is partially bounded
by a first wall 34 and an opposing second wall 36. First wall 34 is
substantially covered with inlet vents from floor to ceiling while second
wall 36 is substantially covered with return vents from floor to ceiling.
Heated air is uniformly blown through all of the inlet vents on first
wall 34 and simultaneously drawn out through all of the return vents on
second wall 36. As a result, an airflow, which is substantially uniform
from floor 24 to roof 22, continually passes across thaw room 26 from
first wall 34 to second wall 36.
[0035] For purposes of illustration, the inventive filtration facility 8
will be discussed below in terms of filtering fetal bovine serum. It is
emphasized that in alternative embodiments filtration facility 8 can be
used in filtering other blood components, other types of serum, media,
reagent, buffers, and other types of fluids.
[0036] Fetal bovine serum is initially harvested at a facility such as a
slaughterhouse. The fetal bovine blood is collected and then processed to
extract the serum. Specifically, the collected blood is clotted and then
passed through a centrifuge so as to remove the clotted portion. The
remaining clear fluid portion of the blood is the raw or unfiltered
serum. The unfiltered serum is placed in plastic bottles and then stored
within a freezer at a storage site so as to remain frozen. The storage
site is typically located at or close to the harvesting facility. In one
embodiment the plastic bottles hold a volume of 2 liters. Other sized
bottles can also be used. When a sufficient quantity of the unfiltered
serum has been collected and frozen, the inventive filtration facility 8
is transported to the storage site. Housings 10 and 12 are positioned
within a warehouse or other temporary shelter and connected to a source
of water and electrical power. In alternative embodiments housings 10 and
12 can be insulated and otherwise designed for operating in an exposed
[0037] To initiate processing, a first batch of frozen serum is placed
within thaw room 26. Although filtration facility 8 can operation in a
continuous flow manner, the serum is typically processed on a batch basis
so that an entire batch can be certified as having common defined
properties. For example, as will be discussed below in greater detail,
once a batch of serum is filtered, the filtered serum is bottled and
marked with a specific lot number. End purchasers and users will
understand that all filtered serum having a common lot number has
substantially identical properties. As such, use of serum from different
bottles having the same lot number should produce substantially the same
results. The batch size can be any desired volume such as 50 liters, 500
liters, 1,000 liters, 2,000 liters or the like. It is noted that the
initial batch of unfiltered serum can comprise bottles of unfiltered
serum derived under different conditions, i.e., different processing
facilities and or different herds of animals.
[0038] In the present example, the batch size is 1,000 liters. As such,
five hundred of the 2 liter bottles containing the frozen unfiltered
serum are placed on wire shelves of transportable carts 38. Carts 38 are
wheeled into thaw room 26 so as to substantially fill thaw room 26 from
floor to ceiling. Each 2 liter bottle is spaced apart on cart 38 so that
air can freely flow around all side of each bottle. Sizing carts 38 so
that the bottles uniformly extend between the floor and ceiling of thaw
room 26 forces the air to flow between the bottles as opposed to simply
flowing over top of or below the carts and bottles. The air blowing into
thaw room 26 is set at approximately 32.degree. C. so that the frozen
unfiltered serum gradually thaws in approximately 10 hours. Other
temperatures and thaw rates can also be used.
[0039] Once the unfiltered serum is thawed, select carts 38 containing the
thawed unfiltered serum are wheeled from thaw room 26 to a staging room
40 of second housing 12. As depicted in FIG. 3, second housing 12
comprises staging room 40 which is accessed through a first door 42 and a
second door 43 each on first end wall 18. First door 42 is made of a
heavy gauge metal that provides protection for second door 43 during
shipping and transport. In alternative embodiments, first door 42 can be
eliminated. Staging room 40 communicates with a non-sterile filtration
room 44 through a door 46. As will be discussed below in greater detail,
substantially disposed within filtration room 44 is a filtration system
[0040] Staging room 40 and filtration room 44 combine to form a filtration
area. Accessible from filtration room 44 through a door 53 is a first
change room 52. First change room 52 accesses a second change room 54
through a door 55. From second change room 54, a clean room 58 is
accessed through a door 56. Disposed within clean room 58 is a laminar
hood 62. In one embodiment, laminar hood 62 comprises a Federal Standard
Class 100 (ISO Class 5) laminar air flow hood. In alternative
embodiments, depending largely upon the type of material being filtered,
laminar hood 62 can have a more stringent or less stringent
classification. A wall 60 is formed between clean room 58 and filtration
room 44. As discussed below in greater detail, a pass-through opening 63
is formed on wall 60. A window 65 is slidable mounted within pass-though
opening 63 so as to selectively open and close pass-through opening 63.
[0041] Second housing 12 also comprises a packing room 64 which is
accessed through an exterior first door 66 and a second door 67 on front
wall 14. Again, first door 66 provides protection for second door 67 and
can be eliminated. A partition wall 68 separates clean room 58 from
packing room 64. A small pass-through portal 70 extends through partition
wall 68 so as to allow bottles of filtered serum to be passed between
clean room 58 and packing room 64. Mounted on opposing ends of
pass-through portal 70 is a first sliding door 72 and a second sliding
door 74.
[0042] In one embodiment each of the rooms of second housing 12 are
designed with conventional clean room standards. For example, all of the
wall are formed from steel panels having powdered coated paint. The
joints of intersecting panels are sealed by caulking. All doors are also
steel panel doors. The window and door frames are also designed to be
flush with the walls so as to minimize any ledges. In alternative
embodiments the walls and doors can be made from other materials or have
[0043] As depicted in FIG. 1, a modular air filtration system 76 is
positioned outside of second housing 12 after housing 12 is positioned
for operation. An air inlet duct 77 and an air outlet duct 78 are
positioned so as to extend between air filtration system 76 and housing
12. Specifically, ducts 77 and 78 couple with duct work formed in roof 22
of second housing 12 such that air filtration system 76 filters the air
within clean room 58 and change rooms 52 and 54. Air filtration system 76
can also be used to filter the air within the other rooms of second
housing 12 such as filtration room 44. To further facilitate air
filtration, in one embodiment 99.995% HEPA filters are located at each
air inlet vent for each room of second housing 12. The HEPA filters can
be limited to just clean room 58 and/or can have a lower particle removal
percentage for other applications.
[0044] It is noted that second housing 12 is configured so that air
filtration system 76 creates a positive air pressure within clean room 58
relative to all other adjacent rooms. In one embodiment this is
accomplished by restricting the air return vents of clean room 58
relative to the air inlet vents thereof so as to produce a positive air
pressure within clean room 58. As a result, any leaks between the rooms
results in air flowing from clean room 58 to the adjacent room, thereby
preventing contaminated air from entering clean room 58. For examples,
doors 72 and 74 on opposing ends of pass-through portal 70, FIG. 3, are
designed to be loose fitting so that filtered air within clean room 58 is
continually flowing from clean room 58, through pass-through portal 70,
and into packing room 64. Likewise, air flows from clean room 58 through
any leaks in pass-though opening 63 into filtration room 44.
[0045] In one embodiment, housing 12 with the rooms thereof and air
filtration system 76 are designed so that clean room 58 meets Federal
Standard Class 1000 (ISO Class 6) requirements. In other embodiments,
depending on what is being filtered, clean room 58 can be designed to
meet more stringent, i.e., ISO Class 5, or less stringent Class
requirements. Depending on the desired Class for clean room 58, it is
appreciated that one of change rooms 52 or 54 could be eliminated.
Furthermore, it is noted that the various rooms can be moved around. For
example, first change room 52 can be designed to be directly accessed
from staging room 40, from packing room 64, or from the exterior. In the
depicted design, an operator enters through staging room 40 and then
subsequently passes through filtration room 44, first change room 52,
second change room 54, and then into clean room 58. Each room is entered
by a door and each room is designed to be increasingly clean.
[0046] Turning to FIG. 4, filtration system 50 generally comprises a fill
container assembly 80, a filter assembly 82, and a pooling container
assembly 84. As depicted in FIG. 5, fill container assembly 80 comprises
a rigid support container 86 having an open top, single-use fill bag 88
disposed therein. Support container 86 is disposed within filtration room
44 and can be secured to second housing 12 such as by straps or other
conventional techniques so as to prevent shifting during transport.
Support container 86 comprises a substantially cylindrical side wall 90
that extends from an upper end 92 to an opposing lower end 94. A floor 96
is formed inside of support container 86 at a position between upper end
92 and lower end 94. Floor 96 comprises a flat, circular base 98 having
an aperture 100 extending therethough. A substantially frustoconical
shoulder 102 encircles base 98 and extends from base 98 to side wall 90.
[0047] In the embodiment depicted side wall 90 comprises an outer wall 104
that extends between opposing ends 92 and 94 and an inner wall 106 that
extends from shoulder 102 of floor 96 to lower end 94. An annular
transition 108 connects outer wall 104 and inner wall 106 at lower end
94. Above transition 108, outer wall 104 and inner wall 106 are spaced
apart so as to form an annular gap 110. An annular seal 112 is disposed
within gap 110 so as to form a bridge between outer wall 104 and inner
wall 106 at the location where inner wall 106 connects with shoulder 102
of floor 96. Seal 112 combines with shoulder 102 to form a portion of
floor 96. In part, seal 112 functions to prevent fill bag 88 from sliding
into gap 110 which could cause failure of fill bag 88.
[0048] In the embodiment depicted, support container 86 is molded so that
outer wall 104, inner wall 106, transition 108, and floor 96 are all
integrally formed as a single molded item. In alternative embodiments,
inner wall 106 and seal 112 can be eliminated. This can be accomplished
by integrally molding floor 96 directly to outer wall 104 or by having a
discrete floor 96 that is connected to outer wall 104 such as by welding,
fasteners, or the like.
[0049] Shoulder 102 of floor 96 is sloped so as to function in part as a
funnel that directs all material toward aperture 100. In alternative
embodiments, floor 96 can be flat, cupped, irregular, or other desired
[0050] Side wall 90 of support container 86 has an interior surface 116
disposed above floor 96. Interior surface 116 and floor 96 bound a first
chamber 118 formed in upper end 92 of support container 86. First chamber
118 can be sized to have any desired volume. For example, first chamber
118 can be sized to hold 50 liters, 100 liters, 200 liters, or other
desired volumes. In the present example, first chamber 118 is sized to
hold approximately 100 liters. Upper end 92 of support container 86
terminates at an upper edge 120 that bounds an opening to first chamber
118. An optional annular lid can be removably disposed over upper edge
120 so as to selectively close the opening.
[0051] Side wall 90 also has an interior surface 122 formed below floor
96. Interior surface 122 and floor 96 bound a second chamber 124 disposed
at lower end 94 of support container 86. An access port 126 extends
through side wall 90 at lower end 94 of support container 86 so as to
provide side access to second chamber 124. In alternative embodiments,
the portion of side wall 90 extending below floor 96 can be replaced with
one or more spaced a part legs or other supports that elevate floor 96
[0052] In the embodiment depicted, support container 86 comprises a barrel
molded from a polymeric material. In alternative embodiments, support
container 86 can be comprised of metal, fiberglass, composites, or any
other desired material. Furthermore, although support container 86 is
shown as having a substantially cylindrical configuration, support
container 86 can be substantially boxed shaped or have a transverse
configuration that is polygonal, elliptical, irregular, or any other
[0053] Fill bag 88 is removably disposed within first chamber 118 of
support container 86. Fill bag 88 comprises a flexible bag-like body 130
having an interior surface 132 that bound a compartment 134. More
specifically, body 130 comprises a side wall 135 that, when body 130 is
unfolded, has a substantially circular or polygonal transverse cross
section that extends between a first end 136 and an opposing second end
138. First end 136 terminates at an open perimeter edge 140. Perimeter
edge 140 bounds a mouth 142 to compartment 134. Second end 138 terminates
at a bottom end wall 144.
[0054] Body 130 is comprised of a flexible, water impermeable material
such as a low-density polyethylene or other polymeric sheets having a
thickness in a range between about 0.1 mm to about 5 mm with about 0.2 mm
to about 2 mm being more common. Other thicknesses can also be used. The
material can be comprised of a single ply material or can comprise two or
more layers which are either sealed together or separated to form a
double wall container. Where the layers are sealed together, the material
can comprise a laminated or extruded material. The laminated material
comprises two or more separately formed layers that are subsequently
secured together by an adhesive.
[0055] The extruded material comprises a single integral sheet which
comprises two or more layer of different material that are each separated
by a contact layer. All of the layers are simultaneously co-extruded. One
example of an extruded material that can be used in the present invention
is the HyQ CX3-9 film available from HyClone Laboratories, Inc. out of
Logan, Utah. The HyQ CX3-9 film is a three-layer, 9 mil cast film
produced in a cGMP facility. The outer layer is a polyester elastomer
coextruded with an ultra-low density polyethylene product contact layer.
Another example of an extruded material that can be used in the present
invention is the HyQ CX5-14 cast film also available from HyClone
Laboratories, Inc. The HyQ CX5-14 cast film comprises a polyester
elastomer outer layer, an ultra-low density polyethylene contact layer,
and an EVOH barrier layer disposed therebetween. Still another example of
a film that can be used is the Attane film which is likewise available
from HyClone Laboratories, Inc. The Attane film is produced from three
independent webs of blown film. The two inner webs are each a 4 mil
monolayer polyethylene film (which is referred to by HyClone as the HyQ
BM1 film) while the outer barrier web is a 5.5 mil thick 6-layer
coextrusion film (which is referred to by HyClone as the HyQ BX6 film).
In yet other embodiments, body 130 can be made exclusively of the HyQ BM1
film or the HyQ BX6 film.
[0056] In one embodiment, the material is approved for direct contact with
living cells and is capable of maintaining a solution sterile. In such an
embodiment, the material can also be sterilizable such as by ionizing
radiation. Other examples of materials that can be used are disclosed in
U.S. Pat. No. 6,083,587 which issued on Jul. 4, 2000 and U.S. patent
application Ser. No. 10/044,636, filed Oct. 19, 2001 which are hereby
incorporated by specific reference.
[0057] In one embodiment, body 130 comprises a two-dimensional pillow
style bag wherein two sheets of material are placed in overlapping
relation and the two sheets are bounded together at their peripheries to
form internal compartment 134. Alternatively, a single sheet of material
can be folded over and seamed around the periphery to form internal
compartment 134. In another embodiment, body 130 can be formed from a
continuous tubular extrusion of polymeric material that is cut to length
and one end seamed closed. In still other embodiments, body 130 can
comprises a three-dimensional bag which not only has an annular side wall
but also a two dimensional bottom end wall 144. The formation of
three-dimension bags will be discussed below in greater detail.
[0058] It is appreciated that body 130 can be manufactured to have
virtually any desired size, shape, and configuration. For example, body
130 can be formed having compartment 134 sized to hold 50 liters, 100
liters, 200 liters, or other desired amounts. In the present example,
body 130 is sized to hold approximately 100 liters. During use, however,
significantly less than 100 liters of serum is typically within body 130
at any given time, thereby avoiding any potential for spilling. Although
body 130 can be any shape, in one embodiment body 130 is specifically
configured to be complementary or substantially complementary to first
chamber 118 of support container 86.
[0059] In any embodiment, however, it is desirable that when body 130 is
received within first chamber 118, body 130 is uniformly supported by
floor 96 and side wall 90 of container support container 86. Having at
least generally uniform support of body 130 by support container 86 helps
to preclude failure of body 130 by hydraulic forces applied to body 130
when filled with serum or other liquids.
[0060] Mounted on bottom end wall 144 of body 130 is a port 150. Port 150
comprises a barbed tubular stem 152 having a flange 154 outwardly
projecting from an end thereof. During assembly, a hole is formed through
body 130 and port 150 passed therethrough. Conventional welding or other
sealing techniques are then used to seal flange 154 to body 130. It is
appreciated that any number of ports can be formed on body 130 and that a
variety of different types and sizes of ports can be used depending on
the type of material to be dispensed into compartment 134 and how the
material is to be dispensed therefrom.
[0061] Fill bag 88 is disposed within first chamber 118 of support
container 86 so that stem 152 passes through aperture 100 on floor 96 of
support container 86. A first end 158 of a first fluid line 160 is
coupled with stem 158. First fluid line 160 passes out through access
port 126 and couples with filter assembly 82 as will be discussed below
in greater detail. Perimeter edge 140 of fill bag 88 is outwardly folded
over the upper edge 120 of support container 86 SO as to open mouth 142
of fill bag 88 and support fill bag 88 within support container 86. Next,
an annular screen tray 154 is seated over upper edge 120 of support
container 86 so as to span across open mouth 142 of fill bag 88. Finally,
an initial filter 156 is laid over screen tray 154. Initial filter 156 is
typically comprised of cheese cloth having a desired porosity. Other
types and sizes of filters can also be used.
[0062] As depicted in FIGS. 3 and 4, filter assembly 82 comprises a filter
rack 164 rigidly mounted to back wall 16 of second housing 12 within
filter room 44. As depicted in FIG. 4, plurality of disposable filters
166A-E and a final filter 167 are mounted on rack 164 and fluid connected
together in series so as to form a filter train. As will be discussed
below in greater detail, final filter 167 forms a portion of pooling
container assembly 84. If desired, to avoid down time in changing
filters, two or more filter trains can be formed in parallel. As one or
more filters of one filter train are being changed, the fluid can be
routed through the second filter train.
[0063] Each filter 166 and 167 comprises a capsule 168 bounding a
compartment 169. An inlet port 170 and an outlet port 172 communicate
with compartment 169. Disposed within compartment 169 is a filter
membrane 174. Filter membrane 174 is disposed such that fluid entering
through inlet port 170 must pass through filter membrane 174 before
exiting through outlet port 172. A bleed valve 173 is mounted on the top
of capsule 168 to enable the removal of air from compartment 169. Bleed
valve 173 communicates with compartment 169 on the inlet side of filter
membrane 174. Similarly, a drain valve 171 is mounted on the bottom of
capsule 168 so as to communicate with compartment 169 on the inlet side
of filter membrane 174. As discussed below in greater detail, drain valve
171 is used to remove residual serum from capsule 168.
[0064] The number, type, and size of filters 166A-E depends on the amount,
type, and speed at which the material is to be processed. For example, in
one embodiment the filter train can comprise two prefilters having a
filter membrane 174 with porosity in a range between about 0.2 .mu.m to
about lom followed by three sterilizing filters each having a filter
membrane 174 with a porosity of 0.1 m. If desired, filters having a
porosity down to 0.04 .mu.m or smaller can be used to remove viruses. In
other embodiment, only one or more filters may be required.
[0065] Filters which can be used in the present invention are available
from the Pall Corporation. Examples of prefilters from the Pall
Corporation that can be used include the Profile prefilter which is a
polypropylene depth filter with tapered pore structure and a pore size of
5 .mu.m; the Profile Star which is a polypropylene filter with a star
shaped pleat structure and a pore size of 5 .mu.m; the Ultipor GF Plus
prefilter which is a bonded glass fiber filter with positive Zeta
potential and a pore size of 20/2 .mu.m; and the Preflow UUA prefilter
which is a resin bonded glass fiber filter having a pore size of 0.2
[0066] The three final filters are designed for mycoplasma removal.
Examples of such final filters available from the Pall Corporation
include the Posidyne NGZ01 filter and the Fluorodyne II DJLP filter each
having a pore size of 0.1 .mu.m. The Posidyne NGZ01 filter incorporates
charge-modified Nylon 6,6 membranes, which exhibit a positively charged
Zeta potential in aqueous solutions. A positively charged filter provides
adsorption-enhanced retention of particles smaller than the filter
rating. The Posidyne NGZ01 filter provides high protein recovery from
sera and most protein solutions, and has a Acholeplasma laidlawii
mycoplasma titer reduction rated at >10.sup.6/cartridge.
[0067] The Fluorodyne II DJLP filter has two layers of PVDF membrane with
a built-in 0.2 micron prefilter layer and a final 0.1 micron layer. The
DJLP filter has a flow rate comparable to the flow rate of traditional
0.2 micron filter, which allows for economical 0.1 micron filtration.
[0068] Filters 166 and 167 come in a variety of different sizes such as 10
inch, 20 inch, 30 inch or the like. Increasing the length of filters 166
and 167 increases the surface area of filter membrane 174, thereby
increasing flow rate and the amount of material that can be processoed.
In one embodiment each capsule 168 is translucent. This features allows
visual assurance that compartments 169 have been properly bled of air so
that complete utilization of the filter membrane is achieved. Completion
of filtration can also be confirmed by observing fluid in the filters.
[0069] A pressure gauge 176 is mounted on each capsule 168 so as to
measure the pressure of the fluid within compartment 169 prior to passing
through the corresponding filter membrane 174. The pressure drop between
two adjacent pressure gauges 176 is a result of the fluid having to pass
through the filter member 174 between the two pressure gauges 176. As
filter membrane 174 becomes increasingly occluded by filtering out
unwanted material, the pressure drop increases. Accordingly, by
continually monitoring the pressure differential between pressure gauges
176, an operator can select the optimal time to replace clogged filters.
[0070] The replacement procedure can comprise shutting down the filtration
process and then replacing the clogged filter. Alternatively, it is
appreciated that parallel routing paths can be formed for one or more of
the filters. Accordingly, as a filter becomes clogged, one or more valves
are activated so that the fluid is routed around the clogged filter while
the clogged filter is being replaced. This configuration eliminates the
need to shut down the filtering process. During most operations, it is
typically only necessary to replace the first filter 166A, if any.
[0071] As mentioned above, in one embodiment filters 166 and 167 are
completely disposable. In such embodiments, filter membrane 174 is
typically sealed within a polymeric capsule 168. In an alternative
embodiment, capsule 168 can comprise a stainless steel reusable housing
in which filter membrane 174 is removably disposed. Of course, this
latter embodiment requires cleansing of the housing between each use.
[0072] As also depicted in FIG. 4, first fluid line 160 has first end 158
fluid coupled with fill bag 88 as discussed above and a second end 159
that is fluid coupled to an inlet side of a pump 178. A second fluid line
161 has a first end 162 fluid coupled to an outlet side of pump 178 and a
second end 163 fluid coupled to inlet port 170 of first filter 166A. Pump
178 draws the fluid from fill bag 88 and passes it through filters 166
and 167. In the depicted embodiment pump 178 comprises a conventional
diaphragm pump having an air regulator. By adjusting the air regulator,
pump 178 can be set to operate so as not to exceed a defined pressure.
That is, as filters 166 and 167 become increasingly occluded, the fluid
pressure increases. The pressure, however, needs to stay below a
predefined level to prevent failure of the system, i.e., rupturing of a
fluid line or seal. Although other pressures can be used, in one
embodiment pump 178 is set not to produce a fluid pressure in excess of
about 60 psi (41 N/m.sup.2).
[0073] Because the unfiltered serum actually passes through pump 178, pump
178 is one of the few items that must be cleaned between the processing
of each separate batch. In an alternative embodiment, pump 178 can
comprise a peristaltic pump. In this embodiment, first fluid line 160 and
second fluid line 161 comprise a single integral line that passes through
the peristaltic pump. Because the peristaltic pump does not actually
contact the unfiltered serum but merely constricts the fluid line to
advance the serum therein, the peristaltic does not need to be cleaned
between different batches. It is sufficient merely to replace the fluid
line. The downside with using a peristaltic pump, however, is that they
typically have a lower flow rate and are typically not configured so as
to prevent exceeding a desired fluid pressure. Other conventional pumps
[0074] Pooling container assembly 84 as depicted in FIG. 4 comprises a
pooling bag assembly 186 as depicted in FIG. 6 and a rigid support bin
184 as depicted in FIG. 11. Turning to FIG. 6, pooling bag assembly 186
comprises a pooling bag 256. Pooling bag 256 comprises a flexible body
258 having an interior surface 260 that bounds a chamber 262. Although
chamber 262 can be any desired volume, in the present example, chamber
262 is configured to hold a volume of at least 1,000 liters so that the
entire batch of serum can simultaneously be held within chamber 262. Body
258 is comprised of a flexible, water impermeable material such as the
various polymeric sheets as previously discussed with regard to fill bag
[0075] In contrast to fill bag 88, however, which has an open mouth, body
258 of pooling bag 256 is sealed closed. As such, it is desirable that
body 258 be comprised of a gas barrier layer that prevents the migration
of contaminating gases into chamber 262. Examples of materials that
include a gas barrier layer include the HyQ CX5-14 cast film and the
Attane type films, as previously discussed. A gas barrier layer is
desirable in body 258 to maintain sterility in the filtered serum
downstream of final filter 167 and to keep the filtered serum free of any
gas phase. When the volume of fill bag 88 is smaller than the volume of
pooling bag 256, the serum spends less time (and is typically colder) in
fill bag 88 than in pooling bag 256.
[0076] Furthermore, although body 258 can comprise a two-dimensional
pillow style bag, in the depicted embodiment, body 258 comprises a
three-dimensional bag. More specifically, body 258 comprises an
encircling side wall 264 that, when body 258 is unfolded, has a
substantially circular or polygonal transverse cross section that extends
between a first end 266 and an opposing second end 268. First end 266
terminates at a two dimensional top end wall 270 while bottom end 268
terminates at a two dimensional bottom end wall 272. A plurality of
spaced apart loops 273 are formed on top end wall 270. Loops 273 enable
pooling bag 256 to be lifted and supported, if desired, during filling of
filtered serum into pooling bag 256.
[0077] Turning to FIG. 7, three dimensional body 258 is comprised of four
discrete panels, i.e., a front panel 274, a back panel 275, a first side
panel 276, and a second side panel 277. Each panel 274-277 has a
substantially square or rectangular central portion 278. Front panel 274
and back panel 275 each have a first end portion 280 and a second end
portion 282 projecting from opposing ends of central portion 278. Each of
end portions 280 and 282 have a trapezoidal configuration with opposing
tapered sides. Each of side panels 276 and 277 has a triangular first end
portion 284 and an opposing triangular second end portion 286 at the
opposing ends of central portion 278. As depicted in FIG. 6,
corresponding perimeter edges of each panel 274-277 are seamed together
so as to form body 258 having a substantially box shaped configuration.
In this assembled configuration, each of panels 274-277 is folded along
the intersection of the central portion and each of the end portions such
that end portions combine to form top end wall 270 and bottom end wall
[0078] Panels 274-277 are seamed together using methods known in the art
such as heat energies, RF energies, sonics, other sealing energies,
adhesives, or other conventional processes. It is appreciated that by
altering the size and configuration of some or all of panels 274-277,
body 258 can be formed having a variety of different sizes and
configurations. The size and configuration of body 258 can also be
altered by varying the number of panels used to make body 258.
[0079] In still other embodiments, it is appreciated that body 80 can be
formed by initially extruding or otherwise forming a polymeric sheet in
the form of a continuous tube. Each end of the tube can then be folded
like the end of paper bag and then seamed closed so as to form a three
dimension body. In still another embodiment, a length of tube can be laid
flat so as to form two opposing folded edges. The two folded edges are
then inverted inward so as to form a pleat on each side. The opposing end
of the tube are then seamed closed. Finally, an angled seam is formed
across each corner so as to form a three dimensional bag when unfolded.
[0080] It is appreciated that the above techniques can be mixed and
matched with one or more polymeric sheets and that there are still a
variety of other ways in which body 258 can be formed having a two or
three dimensional configuration. Further disclosure with regard to one
method of manufacturing three-dimensional bags is disclosed in U.S.
patent application Ser. No. 09/813,351, filed on Mar. 19, 2001 of which
the drawings and Detailed Description are hereby incorporated by specific
[0081] Pooling bag 256 further comprises a plurality of tubular ports
mounted on body 258 so as to communicate with chamber 262. As depicted in
FIG. 7, a filter port 288 and two circulation ports 290 and 292 are
mounted on first end portion 280 of front panel 274 of body 258. A single
outlet port 294 is formed on second end portion 282 of front panel 274 of
body 258. Pooling bag assembly 186 also comprises various fluid lines
being fluid coupled with the above referenced ports. For example, as
depicted in FIG. 6, a third fluid line 298 has a first end 300 fluid
coupled with outlet port 172 of final filter 167 and an opposing second
end 302 fluid coupled with filter port 288.
[0082] Likewise, a dip tube 304 is disposed within chamber 262 of pooling
bag 256 and has a first end 306 disposed at circulation port 290 and a
second end 308 disposed toward bottom end wall 272 of pooling bag 256. In
turn, a circulation line 310 has a first end 312 fluid coupled with
circulation port 290 and a second end 314 fluid coupled with circulation
port 292. As depicted in FIGS. 4 and 6, a pump 316 is coupled with
circulation line 310. Pump 316 functions to draw filtered serum or other
fluid located at the bottom of pooling bag 256 up through dip tube 304,
through circulation line 310 and then back into the top of pooling bag
256 though circulation port 292. The operation of pump 316 thus functions
to mix the filtered serum within pooling bag 256 so that the filtered
serum becomes and remains homogenous. Although any type of pump can be
used, in one embodiment pump 316 comprises a peristaltic pump. Because
the peristaltic pump does not directly contact the fluid, the peristaltic
pump can be repeatedly used for different batches without cleaning or
[0083] Depicted in FIG. 8 is one embodiment of how dip tube 304 is mounted
to pooling bag 256. Specifically, circulation port 290 comprises a
tubular, barbed stem 320 that bounds a channel 322 extending
therethrough. Stem 320 has a first end 321 and an opposing second end
323. A flange 324 is mounted on second end 323 of stem 320 and is secured
to front panel 274 of pooling bag 256.
[0084] A diptube connector 328 is partially disposed within circulation
port 290. Diptube connector 328 comprises a tubular, barbed stem 330
having a first end 334 and an opposing second end 336. An annular flange
338 encircles and outwardly projects from second end 336 of stem 330.
Flange 338 has a maximum diameter that is larger than or equal to the
first end 321 of circulation port 290. During assembly, first end 334 of
diptube connector 328 is secured by frictional engagement within first
end 306 of dip tube 304. Second end 308 of dip tube 304 is then advanced
through circulation port 290 until flange 338 of diptube connector 328
seats on first end 321 of circulation port 290.
[0085] To enable diptube connector 328 to fit within circulation port 290,
circulation port 290 is typically made of an increased size. In one
embodiment, an adapter 340 is used to reduce the size of the tube that
extends from circulation port 290. Adapter 340 comprises a tubular body
342 that bounds a channel extending between a barbed first end 346 and an
opposing barbed second end 348. First end 346 of adapter 340 has a
configuration and size similar to first end 321 of circulation port 290.
A transition tube 350 is fluid coupled with and extends between first end
321 of circulation port 290 and first end 346 of adapter 340. In
contrast, second end 348 of adapter 340 is smaller than first end 346 and
thus is sized to fit within a tube 352 that is smaller than transition
tube 350.
[0086] In one embodiment, circulation ports 290 and 292 can be the same
size and circulation line 310 can have a constant size extending
therebetween. In an alternative embodiment, circulation port 292 can be
smaller than circulation port 290. In this embodiment, circulation line
310 comprises transition tube 350, adapter 340, and tube 352. Further
disclosure with regard to diptube connector 328 and adapter 340 is
provided in U.S. Pat. No. 6,086,574, issued Jul. 11, 2000, which is
[0087] Finally, as depicted in FIG. 6, pooling bag assembly 186 also
includes a fill line assembly 356 coupled with outlet port 294. As
depicted in FIG. 9, fill line assembly 356 comprises a tee connect 358
fluid coupled with outlet port 294 by way of a flexible transition tube
360. In one embodiment transition tube 360 is comprised of silicone
tubing having a inside diameter (ID) of 0.875 inches (2.22 cm). Fluid
coupled to the two remaining ports of tee connect 358 are two fill lines
362A and B. As fill lines 362A and B are identical, only one of the fill
lines will be discussed herein.
[0088] Fill line 362A comprises a flexible tube 364 extending from tee
connector 358 to an elbow connector 366. A flexible tube 368 extends from
elbow connector 366 to a first reducing coupling 370. A flexible tube 372
extends from first reducing coupling 370 to a second reducing coupling
374. Flexible tube 372 has an ID of 0.375 inches (0.95 cm). A hose clamp
373 is mounted on tube 372 so that the flow of fluid through tube 372 can
be selectively stopped. A flexible tube 376 extends from second reducing
coupling 374 to a third coupling 378. Tube 376 has an ID of 0.312 inches
(0.79 cm). A flexible tube 380 extends from third coupling 378 to a
filling bell 382. Tube 380 has an ID of 0.375 inches (0.95 cm). Filling
bell 382 comprises a shroud 384 having a nozzle 386 mounted thereon so
that the free end of nozzle 386 is disposed within shroud 384. Nozzle 386
also includes a tubular stem (not shown) that extends outside of shroud
384 and is coupled with tube 380. Finally, filling bell 382 is positioned
within a polymeric bag 388 which is sealed around tube 380 by a cable tie
390. Bag 388 thus seals nozzle 386 in a closed environment.
[0089] In one embodiment, tubes 360, 364, 368, 372, and 376 are all
comprised of silicone which has desired properties with regard to
durability and flexibility. The tubes start large to optimize flow in
each fill line but are subsequently reduced. As discussed below in
greater detail, the size reduction is made to optimize pumping and
filling parameters. Filling bell 382 is molded as a single integral unit
that is comprised of polycarbonate. Tube 380 is comprised of a medical
grade PVC. By forming tube 380 out of PVC, as opposed to silicone, tube
380 can be secured to filling bell 382 using an adhesive. In alternative
embodiments, the tubes can be made of different materials and can have
different sizes. Furthermore, in other embodiments, fill line assembly
356 can comprise one fill line or three or more fill lines.
[0090] In one embodiment, pooling bag assembly 186, including final filter
167, is preassembled as a discrete unit. In this preassembled state, as
shown in FIG. 10, pooling bag 256 is folded and collapsed with
substantially all of the air removed therefrom. Fill line assembly 356 is
coil and placed within a polymeric bag 392 which is tied closed around or
adjacent to outlet port 294. The entire pooling bag assembly 186,
including final filter 167, is then sealed within a first packaging bag
394 which is then sealed within a second packaging bag 396, each bag 394
and 396 being heat sealed closed. The entire pooling bag assembly 186
with the packaging bags is then gamma-irradiated so as to sterilize
pooling bag assembly 186 and any air trapped therein.
[0091] Turning to FIG. 11, support bin 184 comprises an encircling side
wall 188 that includes a front panel 190, an opposing back panel 191, and
a pair of spaced apart side panels 192 and 193 extending therebetween.
Each of panels 190-193 has an upper end 194 and an opposing lower end
196. Extending between each of panels 190-193 at lower end 196 is a floor
198 (FIG. 12).
[0092] A support leg 200 is mounted at the intersection of each of panels
190-193 with each support leg 200 extending below floor 198. As a result,
legs 200 elevate floor 198 off the ground or support surface so as to
provide access to the bottom surface of floor 198. Any structure that
enables access to the bottom surface of floor 198 can also be used to
replace legs 200. A pair of spaced apart fork lift channels 202A and B
extend between two adjacent legs 200 along side panels 192 and 193. Each
channel 202 bounds an opening 203 adapted to receive a fork from a fork
lift. A motorized or hand operated fork lift can thus be used to easily
lift and move support bin 184. Support bin 184 is periodically moved so
as to allow cleaning therebehind.
[0093] Support bin 184 has an interior surface 204 which bounds a chamber
206. Upper end 194 of side wall 188 terminates at an upper edge 208.
Upper edge 208 bounds an opening 210 which communicates with chamber 206.
A lid can be used to selectively cover opening 210 to chamber 206.
Horizontally and vertically staggered slots 212 extend through front
panel 190 and allow visual determination of a fluid level within chamber
206. Chamber 206 can be any desired volume. By way of example, support
bin 184 can be formed having chamber 206 with a volume of 500 liters,
1,000 liters, 1,500 liters or other desired volumes. In the present
example, chamber 206 is configured to hold a volume of at least 1,000
[0094] Front panel 190 comprises a fixed panel 214 and a door 216. Fixed
panel 214 bounds a doorway 219 (FIG. 13) which is selectively opened and
closed by door 216. Specifically, door 216 is mounted to fixed panel 214
by hinges 217. Latches 218 mounted on the opposing side of door 216
selectively lock door 216 to fixed panel 214. As will be discussed below
in greater detail, opening of door 216 enables easy access to chamber 206
and floor 198 of support bin 184 through doorway 219. Support bin 184 can
be comprised of metal, such as stainless steel, fiberglass, composites,
plastic, or any other desired material. Furthermore, although support bin
184 is shown as having a substantially box shaped configuration, support
bin 184 can be any desired configuration or have a transverse
[0095] As depicted in FIG. 12 and 13 (FIG. 13 being shown without door
216), floor 198 comprises a substantially flat base floor 220 having a
top surface 221 and an opposing bottom surface 222. Base floor 220 is
centrally disposed along front panel 190 and projects from front panel
190 toward back panel 191. Base floor 220 has an outer edge 224 and an
inner edge 225. Floor 198 further comprises a first side floor 226 that
downwardly slopes from side panel 192 to base floor 220, a second side
floor 228 that downwardly slopes from side panel 193 to base floor 220,
and a back floor 229 that downwardly slopes from back panel 191 to base
floor 220. As a result, floor sections 226-228 are sloped to direct or
funnel material to base floor 220. In an alternative embodiment, all of
floor 198 can be substantially flat. Inner edge 225 of base floor 220
bounds slot 230 which extends through base floor 220. Inner edge 225
includes a back edge 232, an opposing side edges 233 and 234. A
semi-circular notch 223 is formed on back edge 232. Depicted in FIG. 13,
opposing side edges 233, 234 and slot 230 also extend along fixed panel
214 of front panel 198 so as to intersect with doorway 219. As such, slot
230 has a substantially L-shaped configuration.
[0096] Depicted in FIGS. 13 and 14, mounted on bottom surface 222 of base
floor 220 along side edges 233 and 234 are bracket assemblies 236A and B.
Each bracket assembly 236 includes a flat elongated spacer 235 that is
disposed directly on bottom surface 222 of base floor 220 but at a
distance back from side edge 233 and 234. A stop plate 229 extends
between spacers 235 at a distance back from back edge 232. Mounted on top
of spacer 235 is an elongated substantially flat slide rail 237. Slide
rail 237 extends along spacer 235 but also outwardly projects therefrom
so as to freely project out toward side edge 233 and 234. As a result, a
channel 238 is formed between slide rail 237 and base floor 220 along
side edges 233 and 234 of base floor 220.
[0097] Spacer 235 and slide rail 237 can each comprise multiple discrete
members or can each be a single integral member. Furthermore, spacer 235
and slide rail 237 can be formed as a combined integral member. Bolts,
welding, or other types of fasteners can be used to secure spacer 235 and
slide rail 237 to base floor 220. A plurality of securing fasteners 239
each include a threaded shaft 240 having a knob 241 mounted on an end
thereof. For reasons as will be discussed below in greater detail, each
shaft 240 threadedly engages with a corresponding slide rail 237 and
passes therethrough so as to communicate with a corresponding channel
[0098] Depicted in FIG. 15, support bin 184 also comprises a substantially
L-shaped retention plate 242. Retention plate 242 comprises base plate
252 having a riser 253 upwardly projecting therefrom. Specifically, base
plate 252 has a front edge 243, a back edge 245 and opposing side edges
246 and 247. A rounded notch 244 is formed on front edge 243 while a
handle 248 downwardly projects from back edge 245. Riser 253 upwardly
projects from back edge 245. A Substantially L-shaped overlay 420 is
mounted on base plate 252 and riser 253. Overlay 420 includes a base
section 422 which extends on base plate 252 from notch 244 to riser 253.
Overlay 420 also includes a tongue 424 which extends along riser 253 and
then freely projects above riser 253. Overlay 420 has a width
substantially equal to the width of slot 230 such that overlay 420 can be
received within slot 230.
[0099] As depicted in FIG. 16, retention plate 242 is mounted to base
floor 220 by sliding side edges 246 and 247 of base plate 252 (FIG. 15)
into corresponding channels 238 of brackets 23 6A and B (FIG. 14). Using
handle 248, retention plate 242 is advanced within channels 238 until
retention plate 242 contacts stop plate 229. In this position, rounded
notches 223 and 244 are aligned so as to form a circular portal 250 which
extends through base floor 220. The remainder of slot 230 on floor 198
and front panel 190 is covered by retention plate 242. Overlay 420 is
received within slot 230 so as to substantially fill in slot 230, thereby
forming a smooth transition with the remainder of interior surface 204.
It is noted that tongue 424 of retention plate 242 is disposed inside of
door 216 when door 216 is closed. As a result, retention plate 242 is
supported by door 216 when a load is applied against retention plate 242
from within support bin 184. Finally, retention plate 242 is secured in
position by manually tightening fasteners 239 so that shafts 240 bear
against retention plate 242.
[0100] It is appreciated that support bin 184 can have a variety of
different configurations. For example, in contrast to having door 216
hingedly mounted, door 216 can be mounted on rails so as to selectively
slide up or down. Furthermore, slot 230 can be designed to only extend
through floor 198 and not pass through fixed panel 214. In yet other
embodiments, base plate 252 of retention plate 242 can comprise two or
more discrete plates having notches which combine to form two or more
portals that receive corresponding ports on pooling bag 256. Examples of
alternative embodiments for support bin 184 are disclosed in U.S. patent
application Ser. No. 10/810,156, filed on Mar. 26, 2004 in the names of
Gregory P. Elgan et al. and entitled Fluid Dispensing Bins and Related
Methods which application is incorporated herein by specific reference.
[0101] During assembly, pooling bag assembly 186 is brought into
filtration room 44 of second housing 12. Packing bags 194 and 196 (FIG.
10) are removed from around pooling bag assembly 186. Door 216 on support
bin 184 is opened and pooling bag assembly 256 is passed though doorway
219 into chamber 206. Fill line assembly 356, still retained within bag
392, is slid within slot 230 so that fill line assembly 356 extends below
floor 198 of support bin 184. In this position, outlet port 294 is
positioned within notch 223 on floor 198. Retention plate 242 is then
mounted on floor 198 as discussed above so that slot 230 is substantially
closed by retention plate 242 except for portal 250 through which outlet
port 294 of pooling bag 256 extends. Pooling bag 256 is thus supported on
floor 198 and retention plate 242.
[0102] Fill lines 362A and B are now removed from bag 392 and extended
through opening 63 in wall 62 (FIG. 3). Notches are formed on window 65
so that window 65 can be closed with the fill lines 362A and B passing
through the notches. Window 65 need only loosely bound fill lines 362A
and B in that the air flow is always from clean room 58 to filtration
room 44. Each filling bell 382 is then positioned within laminar hood 62
located within clean room 58. In the embodiment depicted, fill line
assembly 356 tees into the two separate fill lines 362A and B prior to
passing through opening 63. In an alternative embodiment, transition tube
360 can be extended to pass through opening 63 prior to teeing into the
two fill lines. Again, where only one fill line is desired, no tee is
[0103] Final filter 167 of pooling bag assembly 186 is lifted out of
support bin 184 and mounted to filter rack 164. Final filter 167 is then
fluid coupled with the preceding filter 166D. Finally, circulation line
310 of pooling bag assembly 186 is connected to pump 316 as discussed
above. In alternative embodiments, it is appreciated that pooling bag
assembly 186 need not be preassembled and sterilized. For example, the
various lines and components can be assembled on site and the sterilized
by steam, vapor, chemical, or local radiation.
[0104] During operation, the bottles of thawed unfiltered serum are
manually opened and poured into compartment 134 of fill bag 88 through
filter 156 (FIG. 5). Pump 178 draws the unfiltered serum out of fill bag
88 and passes it though the train of filters 166, through final filter
167, and into chamber 262 of pooling bag 256 (FIGS. 4 and 6). However,
prior to passing the now filtered serum into pooling bag 256, the air
within filters 166 is first removed. This is accomplished by initially
clamping closed fluid line 298 which extends between final filter 167 and
pooling bag 256. The bleed valve 173 for each filter 166 is opened and a
flask positioned below each bleed valve 173. When the pump 178 is
initially activated, the serum flowing into the filters pushes the air
out through the bleed valves 173. The air does not pass between adjacent
filters because filter membrane 174 does not allow air to pass
therethrough. Once serum starts passing through a corresponding bleed
valve 173, the bleed valve is closed. The serum collected in the flask
below the bleed valve is then poured back into fill bag 88. When all of
the air is removed from each of filters 166, fluid line 298 is opened. As
such, the only air that passes into pooling bag 256 is the air within
final filter 167 and fluid line 298. This air, however, was already
sterilized with the sterilization of pooling bag assembly 186.
[0105] As the unfiltered serum is pumped out of fill bag 88, additional
unfiltered serum is poured into fill bag 88. Because fill bag 88 does not
function to pool the batch of unfiltered serum, fill bag 88 can be
significantly smaller than pooling bag 256. In an alternative embodiment,
however, fill bag 88 can also be sized to simultaneously hold and pool
the entire batch of unfiltered serum. During filtering of the serum, hose
clamps 373 on fill lines 362A and B are closed (FIG. 9). As a result, all
of the serum passing through filters 166 and 167 is collected within
pooling bag 256. Because pooling bag 256 is empty and collapsed at the
time of placement, pooling bag 256 slowly inflates as the filtered serum
passes therein.
[0106] The above filtration process is continued until all of the first
batch of serum has passed through fill bag 88 and pump 178. Once pump 178
runs dry, the flow of fluid through filters 166 and 167 stops. However,
depending on the size of filters 166 and 167, several liters of serum can
be retained within filters 166 and 167. Part of the serum is held within
capsule 168 of the filter on the inlet side of filter membrane 174 while
the remainder of the serum has passed through membrane 174 and is thus
held on the outlet side of membrane 174.
[0107] To recoup the serum remaining within filters 166 and 167, first end
162 of second fluid line 161 is disconnected from pump 178. Pressurized
air is then delivered into second fluid line 161 through first end 162.
The air forces the serum within second fluid line 161 and within capsule
168 on the inlet side of filter membrane 174 to pass through filter
membrane 174 of first filter 166A. In so doing, a corresponding volume of
serum is displaced downstream through filters 166 and 167 and dispensed
into pooling bag 256. First filter 166A is then disconnected from second
filter 166B. Any serum remaining within first filter 166A on the inlet
side of filter membrane 174 is removed through drain valve 171 into a
collection container. The serum within first filter 166A on the outlet
side of filter member 174 is also dispensed into the collection
container. This can be accomplished by inverting first filter 166A and
pouring the serum out though outlet port 172. Alternatively, each filter
166 can be made with a drain port that is fluid coupled with the outlet
side of filter membrane 174. The serum dispensed into the collection
container is termed residual serum.
[0108] Once first filter 166A is disconnected from second filter 166B,
pressurized air is applied to inlet port 170 of second filter 166B.
Again, the air forces the serum on the inlet side of filter membrane 174
of second filter 166B to pass through the filter membrane 174, thereby
displacing more filtered serum into pooling bag 256. Second filter 166B
is then disconnected from third filter 166C. The residual serum within
second filter 166B is then also drained into the collection container.
The above process is then repeated for the remainder of filters 166.
Finally, the pressured air is applied to final filter 167 so as to force
the fluid through filter membrane 154 thereof. Final filter 167, however,
is not disconnected from pooling bag 256 until all of the filtered serum
is drained from pooling bag 256. Final filter 167 is then removed and any
residual serum therein drained into the collection container. The
residual serum for each different batch is collected and then
subsequently filtered and pooled as a separate batch that is specially
[0109] As a result of the above processing, substantially all of the
original 1,000 liters of the first batch of serum, after filtration, is
simultaneously disposed within pooling bag 256. This isolated collection
of the filtered serum produces a true pool of the filtered serum. Pump
316 is then activated so that the filtered serum within pooling bag 256
is continually mixed. As a result, the filtered serum becomes and remains
[0110] It is appreciated that in alternative embodiments two or more
different types of liquids can be poured into fill bag 88 for a given
batch. For example, two or more different types of serum, such as calf
and fetal bovine serum, can be added into fill bag 88 for a single batch.
In still other embodiments, one or more liquids and/or one or more
dissolvable solids can be introduced into fill bag 88 for a given batch.
Conventional mixing systems can be used to mix the contents within fill
bag 88 to dissolve the solids. Here it is noted that because the batch is
pooled within pooling bag 256, the different liquids and/or dissolvable
solids can be added at any time or concentration within fill bag 88. For
example, if desired, different growth factors can be added to the serum
within fill bag 88 at any time in the batch process.
[0111] It is also noted that in some processes there are desirable
benefits in being able to add certain components late in the process. For
example, media is typically prepared by mixing a powder component with
purified water. During the mixing process, oxygen from the surrounding
air is absorbed into the solution. The oxygen alters the pH of some
mixtures by striping carbon dioxide from the liquid which reduces the
bicarbonate concentration of the media. By using the present invention,
the bicarbonate can be added last within fill bag 88 and then uniformly
mixed within pooling bag 256. Because the bicarbonate is added last, the
bicarbonate is subject to minimal mixing, thereby minimizing the
reduction in bicarbonate and thus maintaining the desired pH.
[0112] Turning to FIG. 17, each fill line 362A and B operates with a
separate dispensing system 400. As each dispensing system 400 is the
same, dispensing system 400 will only be discussed with regard to fill
line 362A. Specifically, laminar hood 62 includes a table top 401. A
stand 402 is disposed within laminar hood 62 on table top 401. An
electronic pinch valve 404 is mounted on stand 402. The end of fill line
362A is mounted on pinch valve 404 so that filling bell 382 suspends from
stand 402.
[0113] Although not required, in one embodiment a retainer 430 has a first
end 431 mounted on stand 402 and an opposing second end 432 secured to
shroud 384 of filling bell 382. Second end 432 of retainer 430 can be
selectively rotated so that filling bell 382 is tipped at a select angle
and retained at that position. By tipping filling bell 382, the serum
dispensed from filling bell 382, as discussed below in greater detail,
can be directed to pass through the mouth of a bottle and then hit
against the side interior surface of the bottle near the top of the
bottle. The serum then flows down along the side interior surface of the
bottle to the bottom of the bottle where the serum is collected. This
processes minimizes foaming of the serum within the bottle. That is, if
the serum is dispensed directly to the bottom of the bottle as opposed to
the side interior surface thereof, the serum entering the serum collected
at the bottom of the bottle can cause air to become entrained within the
collected serum and thus cause foaming.
[0114] A scale 406 is positioned on table top 401 directly below filling
bell 382. Fill line 362A is also coupled with a peristaltic pump 408
disposed within clean room 58. Hose clamps 373 are released on fill lines
362 such that operation of peristaltic pump 408 causes the filtered serum
to be drawn out of pooling bag 256 and passed through fill lines 362.
Finally, a foot pedal 410 is disposed below table top 401. Each of pinch
valve 404, scale 406, peristaltic pump 408, and foot pedal 410 are in
electrical communication with a central processing unit (CPU) 412.
[0115] During dispensing, an operator sits in front of table top 401 and
places a presterilized bottle 414 on scale 406. The open mouth of bottle
414 is disposed below nozzle 386 and is covered by shroud 384. Shroud 384
prevents any unwanted material that might be floating within laminar hood
62 from falling into or being drawn into bottle 414 during filling. As
discussed above, shroud 384 can be tipped. In one embodiment bottle 414
is comprised of PETE or PETG although other materials can also be used.
Bottle 414 is typically sized to hold 125 ml, 500 ml or 1 liter. Other
sizes can also be used. CPU 412 is inputted with the desired fill volume
for bottle 414 and the known density of the serum. The operator steps on
foot pedal 410 which in turn causes CPU 412 to instruct peristaltic pump
408 to rotate a set number of times so as to dispense a predetermined
first volume of filtered serum into bottle 414. Once the first volume is
dispensed, pinch valve 404 is then activated so as to pinch fill line
362A closed, thereby preventing any serum from leaking out of nozzle 386.
[0116] The first volume of filtered serum dispensed into first bottle 414
is slightly more than the desired fill volume. Once the first volume is
dispensed, scale 406 measures the weight of bottle 414 containing the
first volume of filtered serum. Based on the weight of the first volume
and the known density of the serum, CPU 412 is able to determine how many
times peristaltic pump 408 should rotate so as to dispense the desired
fill volume into the next bottle. The number of times peristaltic pump
408 rotates to dispense the desired fill volume varies slightly during
the filling process due to the head pressure on the filtered serum within
fill line 362A. That is, the head pressure within fill line 362A is
highest when pooling bag 256 is filled with serum and decreases as the
level of serum decreases within pooling bag 256. In turn, as the head
pressure decreases, the number of turns needed to dispense the desired
fill volume incrementally increases. It is noted that the diameter of
fill line 362A is decreased, as discussed above, in that peristaltic pump
408 can more accurately measure and dispense fluids when it operates with
smaller tubing.
[0117] Once first bottle 414 is filled and weighed, the operator removes
first bottle 414 from scale 406 and screws a cap thereon. A second bottle
414 is then placed on scale 406. Again, based on the weight of the serum
in first bottle 414, CPU 412 instructs peristaltic pump 408 to rotate a
select number of times so as to fill second bottle 414 with the desired
fill volume. Scale 406 then weighs the volume of serum within second
bottle 414. In turn, this weight is used by CPU 412 to determine how many
times peristaltic pump 408 need to rotate to dispense the desired fill
volume into the next bottle. As such, the weight of the serum in a prior
bottle 414 is used to adjust the rotation of peristaltic pump 408 so that
the desired fill volume is dispensed into each bottle, within acceptable
tolerances, as the head pressure within fill line 362 drops. The process
is continually repeated to fill empty bottles until all of the serum is
removed from pooling bag 256.
[0118] In one embodiment of the present invention, means are provided for
dispensing a predetermined quantity of fluid through fill line 362. One
example of such means includes the system as discussed above which
includes the scale, CPU, and pump. It is appreciated, however, that a
variety of other systems can also be used. For example, in one
alternative the scale can be eliminated. Alternative types of pumps can
then be used that can precisely measure the desired fill volume. In yet
other embodiments, various sensors can be used to measure the actual head
pressure. The CPU can thus use the known fluid pressure when activating
the peristaltic pump. In still other embodiments, the dispensing can be
based on weight. That is, the CPU can instruct the pump to stop when the
scale measures a predefined weight. Other techniques known in the art can
[0119] When desired, CPU 412 can be programmed to fill bottles 414 of a
variety of different sizes for a given batch of pooled filtered fluid. By
way of example and not by limitation, for a given batch of one thousand
liters, the fluid can be dispensed into five hundred 1 liter bottles,
five hundred 500 ml bottles and two thousand 125 ml bottles. The 125 ml
bottles can then be used for quality control, retention, and quality
[0120] Returning to FIG. 3, to advance filled bottle 414 the operator
within clean room 58 opens first door 72 of pass-through portal 70 and
places bottle 414 within pass-through portal 70. First door 72 is then
closed. An operator within packing room 64 then opens second door 74 and
removes filled bottle 414 from pass-through portal 70. Second door 74 is
then closed. As previously discussed, clean room 58 is placed under a
positive air pressure relative to packing room 64 so that air always
flows from clean room 58, through pass-through portal 70, to packing room
64, thereby preventing contamination from entering clean room 58 through
pass-through portal 70. Within packing room 58, the operator uses a screw
device to torque down the cap on bottle 414. The operator then heat
shrinks a seal around the cap and places a label on bottle 414.
[0121] Once sealed, bottle 414 is placed on a transportable cart 416
within packing room 64. When cart 416 is filled with bottles of filtered
serum, cart 416 is transported to freezer room 28 of first housing 10
through an outer door 426 and an inner door 428 (FIG. 2). Again, outer
door 426 provides protection for inner door 428 during transport and can
be eliminated. It is desirable to quickly freeze the filtered serum so as
to prevent separation or settling of the filtered serum within bottles
414. As such, it is desirable to freeze the filtered serum within a 12
hour period. To accomplish this, freezer room 28 is held at a temperature
of -20.degree. C. Other temperatures and freezing periods can also be
used. Once frozen, bottles 414 are removed to a separate long term
storage facility for subsequent sale.
[0122] In one embodiment, particularly where there is a significant delay
being filtering the first batch and a second batch, once all of the first
batch of serum is bottled, used pooling bag assembly 186, filters 166,
fill bag 88 and fluid lines 160 and 161 are removed and replaced with a
new bag assembly 186, filters 166, fill bag 88 and fluid lines 160 and
161. The only structure that is reused and needs to be cleaned because it
directly contacts the serum is diaphragm pump 178.
[0123] In alternative embodiments, where a second batch of serum has been
thawed so as to be processed directly after the first batch, it is
envisioned that each of used pooling bag assembly 186, filters 166, fill
bag 88 and fluid lines 160 and 161 could be reused. Alternatively, select
components such as pooling bag assembly 186 and/or filters 166 could be
replaced between different batches.
[0124] In the illustrated embodiment where the liquid being filtered is
fetal bovine serum, it is generally not necessary to take samples for
in-process testing or quality control or for retention and quality
assurance at any point upstream of the dispensing system 400. In other
embodiments, however, especially when more than a single liquid is
introduced into fill bag 88, a port for withdrawing such samples can be
provided either upstream of filters 166,167, such as on fluid line 160 or
161, or downstream of that filters 166,167, such as on fluid line 298.
The port allows samples to be taken and tested.
[0125] In some applications, operation of the pump 178, and/or other fluid
flows, can be stopped or reduced to a subnormal rate until the test
results have been completed and, if appropriate, additional materials
added to fill bag 88 to bring the tested parameter into a desired range
or value. In some instances, fill bag 88 holds at any one time no more
than a fraction (e.g., one third or one quarter) of the fluid for an
entire batch. Each sub-batch of unfiltered fluid within bag 88 is tested
before being pumped by pump 178 through the filtration system. Pump 316
is operated to create and maintain homogeneity within pooling bag 256 as
soon as the first batch of filtered fluid has reached an appropriate
partially-full level within pooling bag 256.
[0126] The depicted embodiment is primarily directed towards a system that
minimizes cleaning between processing of different batches. In
alternative embodiments, however, it is appreciated that some or all of
the disposable components can be replaced with corresponding reusable
components that require cleaning between uses. For example, pooling bag
256 and/or fill bag 88 can be replaced with stainless steel containers.
Likewise, the various fluid lines can be replaced with fixed stainless
steel lines while the disposable cartridges for filters 166 can be
replaced with reusable stainless steel housing.
[0127] Furthermore, in the depicted embodiment, because pooling bag
assembly 186 is presterilized, no in situ sterilization of components
and/or connections is required. In alternative embodiments, however, it
is appreciated that the various components of pooling bag assembly 186
can be assembly within filter room 44 and then sterilized by conventional
process such as steam, vapor, chemical, or local radiation.
[0128] It is also appreciated that in alternative embodiments filtration
facility 8 need not include both of housings 10 and 12 or can include
duplicates of housing 10 and 12. For example, some storage facilities may
include a fixed thaw room and quick freezer room. In these embodiments,
filtration facility 8 may only comprise second housing 12 because all of
the required elements for filtering and pooling the fluid to achieve and
maintain homogeneity are contained within second housing 12. As such,
only second housing 12 needs to be transported to the storage facility to
filter the serum or other fluids. In yet other embodiments where a
storage facility has a large supply of serum or other fluids that must be
filtered quickly, duplicates of housing 10 and/or 12 can be transported
to the storage facility to expedite filtering. It is also appreciated
that each of housing 10 and 12 can have a variety of different designs.
For example, each of housing 10 and 12 can comprise a plurality of small
housings that are designed to function as separate units or can be
selectively coupled together during use. For example, each separate room
or combination of rooms could be formed from a separate housing.
[0129] Furthermore, when the mobile filtration facility of the present
invention is used to filter and pool other fluids such as human blood
serum or plasma or fractions, appropriate temperature controls can be
built into second housing 12. As such, there would be no need for the
thawing or refreezing steps associated with first housing 10. Thus, for
example, staging room 40 in second housing 12 can receive individual bags
of human blood serum which had previously been collected for transfusion
purposes and stored cold, but were beyond their expiration dates for use
in transfusion purposes. The blood could still be pooled, adjusted with
various components and used as clinical chemistry control materials or
various other in vitro diagnostics or research purposes.
[0130] Once all of the serum has been processed at the storage facility,
filtration facility 8 can be transported to a next storage facility for
processing the serum thereat. In this regard, filtration facility 8 can
be transported to a variety of different locations within a given country
and/or to a variety of different countries around the world. Filtration
facility 8 thus provides a quick, efficient and economical way of
filtering serum or other fluids at locations around the world while
eliminating the need to build, operate, and maintain a fixed filtration
facility. Because the serum or other fluids can be maintained at or
proximate to the location where the fluid was initially harvested or
produced, use of the inventive filtration facility 8 eliminates the need
to obtain import licenses and provides greater ease in documenting origin
and history of filtered serum or other fluid.
[0131] In still other embodiments, it is envisioned that filtration
facility 8 can be shipped to a designated location and permanently
maintained thereat. For example, this can be done at a remote location or
in third world countries where it may be difficult to build a clean room.
It is also appreciated that the above disclosure of the present invention
comprises a number of discrete inventions that can be used independently
or in combination with other systems. For example, filtration system 50
or the discrete components thereof are not limited to being used in a
mobile filtration facility but can also be used in a conventional fixed
facility having a clean room and/or filtration system.
[0132] The present invention may be embodied in other specific forms
illustrative and not restrictive. The scope of the invention is,
therefore, indicated by the appended claims rather than by the foregoing
description. All changes which come within the meaning and range of
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