WO1996031748A1 - A freeze-drying bag and method for minimizing contamination of freeze-dried products - Google Patents

A freeze-drying bag and method for minimizing contamination of freeze-dried products Download PDF

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Publication number
WO1996031748A1
WO1996031748A1 PCT/US1996/000469 US9600469W WO9631748A1 WO 1996031748 A1 WO1996031748 A1 WO 1996031748A1 US 9600469 W US9600469 W US 9600469W WO 9631748 A1 WO9631748 A1 WO 9631748A1
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WO
WIPO (PCT)
Prior art keywords
bag
freeze
drying
sterile barrier
barrier layer
Prior art date
Application number
PCT/US1996/000469
Other languages
French (fr)
Inventor
C. Bradford Jones
Original Assignee
W.L. Gore & Associates, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by W.L. Gore & Associates, Inc. filed Critical W.L. Gore & Associates, Inc.
Priority to AU47551/96A priority Critical patent/AU4755196A/en
Publication of WO1996031748A1 publication Critical patent/WO1996031748A1/en

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Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Definitions

  • This invention relates to a bag for use in freeze-drying and a method of freeze-drying.
  • the bag is designed to protect the contents from contamination while allowing water vapor to escape during the freeze-drying process.
  • Freeze-drying or lyophilization is used for the preservation of a wide variety of foods, pharmaceutical, and biological products. Extreme care must be taken in the handling and processing of many of these products to minimize the opportunity for contamination.
  • freeze-drying processes involve placing open containers of material in the freeze-dryer.
  • the containers remain open to the environment until the freeze-drying process is complete to allow a path for water vapor to be removed from the product.
  • This practice exposes the product to potential contamination during the freeze-drying process.
  • the equipment is often sterilized using steam or chemicals before loading each new batch of product. This practice is time consuming and expensive.
  • Products may also be exposed to contaminants during transportation to and from the freeze-dryer.
  • the entire operating area in which freeze-drying is carried out may also undergo sterilization treatment to minimize exposure of the product to contaminants. This adds to the labor and costs associated with protection of the product from contamination.
  • products may be re-packaged after freeze-drying thus presenting yet another opportunity to introduce contaminants into the freeze- dried product.
  • freeze-drying equipment is expensive and freeze-drying cycles are generally very long. Many hours or even several days are consumed for the processing of a single batch of material.
  • freeze-dryer operators it is common for freeze-dryer operators to maximize the use of their capital investment in the equipment by fully loading the freeze-drying chamber every time it undergoes a freeze-drying cycle. This in turn results in the common practice of freeze-drying different materials in the same freeze-drying chamber at the same time. As the different materials are in open containers or trays, cross contamination of the product can, and commonly does, occur.
  • Freeze-drying techniques have been proposed to attempt to overcome the disadvantages associated with freeze-drying in open containers.
  • European Patent No. 343,596 (to Bergmann er al.) describes a container that has been designed to protect freeze-dried products from contamination during the freeze-drying process.
  • the container is described as having at least one side that includes a fixed "hydrophobic, porous, germ-tight, water vapor-permeable membrane.” Water vapor can escape the closed container through this porous membrane, while the membrane presents a barrier to contamination.
  • freeze-drying containers attempt to address the concerns of product contamination by freeze-drying equipment and the area surrounding the freeze-drying equipment.
  • attempts at implementing these freeze- drying techniques on a production scale have met with limited success.
  • porous venting material such as paper or spunbonded polyolefins
  • Other venting materials have proven too weak to scale up into large bags that can reliably hold several liters of liquid without breaking during handling.
  • a need exists for a bag and freeze-drying technique that addresses the concerns of product contamination by freeze-drying equipment and the area surrounding the freeze-drying equipment and performs on a practical production scale.
  • This invention provides a practical, durable freeze-drying bag that has good water vapor flow, good resistance to breakage, wetting, and abrasion, and excellent sterile barrier properties.
  • the freeze-drying bag of the present invention incorporates a laminate of a liquid water resistant, water-vapor-permeable, sterile barrier layer and a backing material that is water-vapor-permeable and is bonded to a surface of the sterile barrier layer.
  • the sterile barrier layer provides a barrier to bacteria and other particulate contamination, while permitting the passage of gases such as air and water vapor.
  • the backing layers provide strength and support to the sterile barrier layer.
  • the backing layer is able to form strong bonds with itself or with other materials used in the bag construction.
  • a further aspect of the present invention is that another material, such as a heat-sealable packaging material, can be used in those areas of the bag where the laminate is not required or may be undesirable.
  • Figure 1 is a perspective view of a freeze-drying bag which incorporates a laminate used in the present invention.
  • Figure 2 is a cross sectional view of a laminate used in the present invention.
  • Figure 3 is a perspective view of a freeze-drying bag formed entirely from a laminate.
  • Figure 4 is a cross sectional view of the freeze-drying bag of Figure 3 taken along axis 4-4.
  • Figure 5 is a cross sectional view of another laminate used in the present invention.
  • Figure 6 is a cross sectional view of a freeze-drying bag with a laminate of Figure 1 taken along axis 6-6.
  • Figure 7 is a freeze-drying bag having a "zip" type closure member.
  • Figure 8 is a freeze-drying bag having a spout and a cap.
  • liquid water resistant, water vapor permeable, sterile barrier venting media is employed as an integral part of the bag.
  • the media can be a small covering on a side of the bag, or can comprise an entire side, or entire bag, or can be located in the closure member of the bag.
  • freeze-drying bag 1 of the invention comprises a laminate 2 of at least one liquid water resistant, water-vapor-permeable, sterile barrier layer 3 and a second water-vapor-permeable support layer or backing 4 bonded to a surface of the sterile barrier layer 3.
  • Laminate 2 is bonded around its periphery to packaging material 5.
  • the bag is formed by sealing, e.g. heat sealing two layers of packaging material 5 around three edges as shown at the bag perimeter 6.
  • the laminate 2 provides a vent from which gases such as air or water vapor may escape from the interior of the bag 1.
  • the laminate 2 may span a small opening on a side of the bag 1 , as in Figure 1 ; or in another embodiment, referring to Figures 3 and 4, the laminate 2 may comprise the entire bag. It can also be located in a closure member of the bag such as in a screw-cap lid or a spout.
  • the water-vapor-permeable, sterile barrier layer 3 of the laminate 2 provides a barrier to bacteria and other particulate contamination, while permitting the passage of gases such as air and water vapor.
  • a bag has one side that is composed of a heat-sealable, water-impermeable packaging material such as a polypropylene film.
  • the other side of the bag contains a venting media panel that has been sealed to a frame of the heat sealable packaging film.
  • the venting media is a two-layer laminate; it has an inner layer that has been selected for its combination of high sterile barrier properties, high resistance to penetration and wetting by liquid water, and low resistance to water vapor flow, such as expanded porous polytetrafluoroethylene (ePTFE).
  • the sterile barrier layer is backed by a support layer 4, such as a non-woven polypropylene fabric, that has been chosen for its strength, its resistance to abrasion, and its ability to seal reliably to the frame of packaging film.
  • the bag is designed for use in the freeze-dry process. In this process, material to be freeze-dried is placed inside the bag, and the bag is sealed, prior to lyophilization. The material and the bag are placed in the freeze-dryer and subjected to the lyophilization process. Water vapor passes out of the container through the venting media during the process. Particulate matter in the container is retained, and contamination from the surroundings are excluded by the sterile barrier properties of the container.
  • containers can be designed with any vent material that is water vapor permeable but which provides effective resistance to bacterial penetration, and still be within the spirit of this invention.
  • Sterile papers, woven or non-woven polymeric fabrics, e.g., spun-bonded polyolefin (Tyvek®), and porous polymer membranes such as expanded porous PTFE are examples. Best performance will be obtained with venting media that are hydrophobic, as such materials can retain liquid and resist leakage under a wide range of conditions. Additional considerations in selecting materials for use as a venting media include the materials' resistance to water vapor flow versus their effective pore size.
  • Nominal pore sizes in the 0.2 to 3.0 micrometer range will yield performance in bacterial challenge tests that is generally associated with "sterile barrier” media.
  • porous expanded PTFE which has a microstructure of nodes interconnected with fibrils (as described in U.S. P. 3,953,566) nominal pores sizes of 0.1 micrometer, or 0.2 or up to 3 or more micrometers, are useful.
  • smaller reference pore sizes in a given material will also yield higher resistance to vapor flow, which can affect productivity in lyophilization.
  • Stretched, porous PTFE is a preferred venting media based on its superior combination of hydrophobicity and water vapor flow for a given nominal pore size. By hydrophobic is meant that the media is resistant to penetration by water.
  • the water-vapor permeable support layer 4 can be made of any material that provides support, added strength, or special sealing properties to the laminate; examples include woven or non-woven fabrics of polypropylene, polyester, polyethylene, or polyvinyl chloride.
  • the two layers can be bonded together with a breathable adhesive or by simply heating if both materials bond on applying heat.
  • the bag is made entirely of the laminate.
  • Figure 4 shows the interior of the bag of Figure 3 with product 13 inside. 1748
  • the backing material 4 can be any durable, water vapor permeable, flexible material.
  • it is a non-woven fabric made of polymeric fibers, such as a non-woven polypropylene.
  • Figure 5 is a drawing of a three layer laminate in which an additional backing layer 14 is bonded to the laminate of Figure 2.
  • Backing layer 14, like backing material 4 can be any durable, water vapor permeable, flexible material.
  • Packaging material 5 used in the bags shown in Figures 1 and 6, can be any convenient packaging material, such as cast or extruded polypropylene, polyester, polyamide, or polyethylene, or a multilayer construction made of two or more such materials.
  • a useful construction is a multi-layer packaging material that uses as, at least one layer, a material that is heat-sealable to the support layer 4.
  • layer 4 is a non-woven polypropylene
  • material 5 could incorporate a cast or extruded polypropylene film, alone or in combination with other materials such as polyester or metal foil.
  • the bag 1 may comprise two sheets of heat-sealable packaging material 5 and 5' in those areas of the bag 1 where the laminate 2 is not required or may be undesirable.
  • the two sheets are bonded along the edges 6 by heat sealing them around three sides of the sheets.
  • the laminate 2 is heat sealed to sheet 5 around its perimeter as shown at 9.
  • bag 1 may include a closure member 10 such as a "zip" type closure member.
  • the closure member 10 may be heat-sealed to the open end of the bag 1.
  • bag 1 may also be equipped with closure member 20, in the form of a cap 11 on spout 12.
  • material 13 to be freeze-dried is placed inside bag 1 , and bag 1 is closed prior to lyophilization.
  • Bag 1 may be closed by heat-sealing, by a closure member 10, or capped (see Figure 8).
  • Bag 1 with material 13 is placed in a freeze-dryer and subjected to a freeze-drying process. Water vapor passes out of the bag 1 through the laminate 2 during the process. Particulate matter in the bag 1 is retained, and contamination from the surroundings is excluded by the sterile barrier properties of the bag 1. If desired, after the freeze dry process, the bag can be placed for storage in a container that presents a barrier to water vapor transmission, or the laminate 2 can be covered with a cover sheet that has very low water vapor transmission, to minimize the chance of rehydrating the dried contents. While particular embodiments of the present invention have been illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims.

Abstract

A freeze-drying bag (1) is described in which part of the bag is made of water-vapor-permeable, sterile barrier (3) bonded to a backing material (4). The bag (1) permits the passage of gases such as air and water vapor, but not passage of bacteria or other particulate contaminants.

Description

TITLE OF THE INVENTION
A FREEZE-DRYING BAG AND METHOD FOR MINIMIZING CONTAMINATION OF FREEZE-DRIED PRODUCTS
FIELD OF THE INVENTION
This invention relates to a bag for use in freeze-drying and a method of freeze-drying. The bag is designed to protect the contents from contamination while allowing water vapor to escape during the freeze-drying process.
BACKGROUND OF THE INVENTION
Freeze-drying or lyophilization is used for the preservation of a wide variety of foods, pharmaceutical, and biological products. Extreme care must be taken in the handling and processing of many of these products to minimize the opportunity for contamination.
Many freeze-drying processes involve placing open containers of material in the freeze-dryer. The containers remain open to the environment until the freeze-drying process is complete to allow a path for water vapor to be removed from the product. This practice, however, exposes the product to potential contamination during the freeze-drying process. To minimize the opportunity for contamination during the freeze-drying process, the equipment is often sterilized using steam or chemicals before loading each new batch of product. This practice is time consuming and expensive.
Products may also be exposed to contaminants during transportation to and from the freeze-dryer. As a result, the entire operating area in which freeze-drying is carried out may also undergo sterilization treatment to minimize exposure of the product to contaminants. This adds to the labor and costs associated with protection of the product from contamination.
Additionally, products may be re-packaged after freeze-drying thus presenting yet another opportunity to introduce contaminants into the freeze- dried product.
In addition to concerns about product contamination by the equipment and the area surrounding the equipment, there is also concern for cross contamination between different batches of product undergoing the freeze- drying process at the same time. Freeze-drying equipment is expensive and freeze-drying cycles are generally very long. Many hours or even several days are consumed for the processing of a single batch of material. As a result, it is common for freeze-dryer operators to maximize the use of their capital investment in the equipment by fully loading the freeze-drying chamber every time it undergoes a freeze-drying cycle. This in turn results in the common practice of freeze-drying different materials in the same freeze-drying chamber at the same time. As the different materials are in open containers or trays, cross contamination of the product can, and commonly does, occur.
Freeze-drying techniques have been proposed to attempt to overcome the disadvantages associated with freeze-drying in open containers. For example, European Patent No. 343,596 (to Bergmann er al.) describes a container that has been designed to protect freeze-dried products from contamination during the freeze-drying process. The container is described as having at least one side that includes a fixed "hydrophobic, porous, germ-tight, water vapor-permeable membrane." Water vapor can escape the closed container through this porous membrane, while the membrane presents a barrier to contamination.
Another technique is taught in U.S. Patent No. 5,309,649 (to Bergmann ef al.) and involves freeze-drying material in a container that has a hydrophobic, porous, microorganism-impermeable and water vapor-permeable membrane.
These freeze-drying containers attempt to address the concerns of product contamination by freeze-drying equipment and the area surrounding the freeze-drying equipment. However, attempts at implementing these freeze- drying techniques on a production scale have met with limited success. For example, porous venting material, such as paper or spunbonded polyolefins, result in poor water vapor flow due to wetting and blocking of the material. Other venting materials have proven too weak to scale up into large bags that can reliably hold several liters of liquid without breaking during handling. Thus, a need exists for a bag and freeze-drying technique that addresses the concerns of product contamination by freeze-drying equipment and the area surrounding the freeze-drying equipment and performs on a practical production scale. SUMMARY OF THE INVENTION
This invention provides a practical, durable freeze-drying bag that has good water vapor flow, good resistance to breakage, wetting, and abrasion, and excellent sterile barrier properties.
The freeze-drying bag of the present invention incorporates a laminate of a liquid water resistant, water-vapor-permeable, sterile barrier layer and a backing material that is water-vapor-permeable and is bonded to a surface of the sterile barrier layer. The sterile barrier layer provides a barrier to bacteria and other particulate contamination, while permitting the passage of gases such as air and water vapor. The backing layers provide strength and support to the sterile barrier layer.
In another preferred aspect of the invention, the backing layer is able to form strong bonds with itself or with other materials used in the bag construction.
A further aspect of the present invention is that another material, such as a heat-sealable packaging material, can be used in those areas of the bag where the laminate is not required or may be undesirable.
The structure, use and advantages of this invention will become further apparent upon consideration of the following non-limiting description in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective view of a freeze-drying bag which incorporates a laminate used in the present invention.
Figure 2 is a cross sectional view of a laminate used in the present invention.
Figure 3 is a perspective view of a freeze-drying bag formed entirely from a laminate.
Figure 4 is a cross sectional view of the freeze-drying bag of Figure 3 taken along axis 4-4.
Figure 5 is a cross sectional view of another laminate used in the present invention. Figure 6 is a cross sectional view of a freeze-drying bag with a laminate of Figure 1 taken along axis 6-6.
Figure 7 is a freeze-drying bag having a "zip" type closure member. Figure 8 is a freeze-drying bag having a spout and a cap.
DETAILED DESCRIPTION OF THE INVENTION
In this invention, liquid water resistant, water vapor permeable, sterile barrier venting media is employed as an integral part of the bag. The media can be a small covering on a side of the bag, or can comprise an entire side, or entire bag, or can be located in the closure member of the bag.
The present invention will now be described with reference to the figures. Common reference numerals refer to similar items. Referring to
Figures 1 and 2, freeze-drying bag 1 of the invention comprises a laminate 2 of at least one liquid water resistant, water-vapor-permeable, sterile barrier layer 3 and a second water-vapor-permeable support layer or backing 4 bonded to a surface of the sterile barrier layer 3. Laminate 2 is bonded around its periphery to packaging material 5. In Figure 1 , the bag is formed by sealing, e.g. heat sealing two layers of packaging material 5 around three edges as shown at the bag perimeter 6.
The laminate 2 provides a vent from which gases such as air or water vapor may escape from the interior of the bag 1. The laminate 2 may span a small opening on a side of the bag 1 , as in Figure 1 ; or in another embodiment, referring to Figures 3 and 4, the laminate 2 may comprise the entire bag. It can also be located in a closure member of the bag such as in a screw-cap lid or a spout.
The water-vapor-permeable, sterile barrier layer 3 of the laminate 2 provides a barrier to bacteria and other particulate contamination, while permitting the passage of gases such as air and water vapor.
Still referring to Figure 1 , in one embodiment, a bag has one side that is composed of a heat-sealable, water-impermeable packaging material such as a polypropylene film. The other side of the bag contains a venting media panel that has been sealed to a frame of the heat sealable packaging film. The venting media is a two-layer laminate; it has an inner layer that has been selected for its combination of high sterile barrier properties, high resistance to penetration and wetting by liquid water, and low resistance to water vapor flow, such as expanded porous polytetrafluoroethylene (ePTFE). The sterile barrier layer is backed by a support layer 4, such as a non-woven polypropylene fabric, that has been chosen for its strength, its resistance to abrasion, and its ability to seal reliably to the frame of packaging film. The bag is designed for use in the freeze-dry process. In this process, material to be freeze-dried is placed inside the bag, and the bag is sealed, prior to lyophilization. The material and the bag are placed in the freeze-dryer and subjected to the lyophilization process. Water vapor passes out of the container through the venting media during the process. Particulate matter in the container is retained, and contamination from the surroundings are excluded by the sterile barrier properties of the container.
In practice, containers can be designed with any vent material that is water vapor permeable but which provides effective resistance to bacterial penetration, and still be within the spirit of this invention. Sterile papers, woven or non-woven polymeric fabrics, e.g., spun-bonded polyolefin (Tyvek®), and porous polymer membranes such as expanded porous PTFE are examples. Best performance will be obtained with venting media that are hydrophobic, as such materials can retain liquid and resist leakage under a wide range of conditions. Additional considerations in selecting materials for use as a venting media include the materials' resistance to water vapor flow versus their effective pore size. Nominal pore sizes in the 0.2 to 3.0 micrometer range will yield performance in bacterial challenge tests that is generally associated with "sterile barrier" media. The smaller the pore size, the more reliable the sterile barrier performance. For the aforesaid, porous expanded PTFE, which has a microstructure of nodes interconnected with fibrils (as described in U.S. P. 3,953,566) nominal pores sizes of 0.1 micrometer, or 0.2 or up to 3 or more micrometers, are useful. On the other hand, smaller reference pore sizes in a given material will also yield higher resistance to vapor flow, which can affect productivity in lyophilization. Stretched, porous PTFE is a preferred venting media based on its superior combination of hydrophobicity and water vapor flow for a given nominal pore size. By hydrophobic is meant that the media is resistant to penetration by water.
The water-vapor permeable support layer 4 can be made of any material that provides support, added strength, or special sealing properties to the laminate; examples include woven or non-woven fabrics of polypropylene, polyester, polyethylene, or polyvinyl chloride.
The two layers can be bonded together with a breathable adhesive or by simply heating if both materials bond on applying heat. In Figures 3 and 4, the bag is made entirely of the laminate. Figure 4 shows the interior of the bag of Figure 3 with product 13 inside. 1748
The backing material 4 can be any durable, water vapor permeable, flexible material. Preferably it is a non-woven fabric made of polymeric fibers, such as a non-woven polypropylene.
Figure 5 is a drawing of a three layer laminate in which an additional backing layer 14 is bonded to the laminate of Figure 2. Backing layer 14, like backing material 4, can be any durable, water vapor permeable, flexible material.
Packaging material 5 used in the bags shown in Figures 1 and 6, can be any convenient packaging material, such as cast or extruded polypropylene, polyester, polyamide, or polyethylene, or a multilayer construction made of two or more such materials. A useful construction is a multi-layer packaging material that uses as, at least one layer, a material that is heat-sealable to the support layer 4. For example, if layer 4 is a non-woven polypropylene, then material 5 could incorporate a cast or extruded polypropylene film, alone or in combination with other materials such as polyester or metal foil.
In this way, two sheets of packaging material 5 can be thermally bonded at perimeter 6, and the laminate 2 can be thermally bonded to the packaging material 5 around the perimeter of laminate 2. As a specific example, referring to Figure 6, the bag 1 may comprise two sheets of heat-sealable packaging material 5 and 5' in those areas of the bag 1 where the laminate 2 is not required or may be undesirable. The two sheets are bonded along the edges 6 by heat sealing them around three sides of the sheets. The laminate 2 is heat sealed to sheet 5 around its perimeter as shown at 9.
Referring to Figure 7, bag 1 may include a closure member 10 such as a "zip" type closure member. The closure member 10 may be heat-sealed to the open end of the bag 1.
Referring to Figure 8, bag 1 may also be equipped with closure member 20, in the form of a cap 11 on spout 12.
In the freeze-drying process according to the present invention, material 13 to be freeze-dried (see Figures 4 and 6) is placed inside bag 1 , and bag 1 is closed prior to lyophilization. Bag 1 may be closed by heat-sealing, by a closure member 10, or capped (see Figure 8).
Bag 1 with material 13 is placed in a freeze-dryer and subjected to a freeze-drying process. Water vapor passes out of the bag 1 through the laminate 2 during the process. Particulate matter in the bag 1 is retained, and contamination from the surroundings is excluded by the sterile barrier properties of the bag 1. If desired, after the freeze dry process, the bag can be placed for storage in a container that presents a barrier to water vapor transmission, or the laminate 2 can be covered with a cover sheet that has very low water vapor transmission, to minimize the chance of rehydrating the dried contents. While particular embodiments of the present invention have been illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims.

Claims

CLAIMS:
1. A sealable bag for use in freeze-drying in which at least a portion of the bag is a laminate of: (a) a sterile barrier layer that has sterile barrier properties, transmits water vapor, and has resistance to liquid water penetration;
(b) a backing material that provides strength and support to the sterile barrier layer, and which is bonded to the sterile barrier layer; and
(c) any remainder of the bag being a heat-sealable packaging material, said material being present in those areas of the bag where the venting material is not required or is undesirable.
2. The bag of Claim 1 , wherein a remainder of said bag is formed from a heat-sealable packaging material for those portions of the freeze-drying bag where the bag does not comprise the laminate
3. The bag of Claim 1 , wherein the freeze-drying bag is formed entirely from the sterile barrier layer and the backing material.
4. The bag of Claim 1 , wherein the water vapor-permeable, sterile barrier layer is selected from sterile paper, non-woven polymer film, and porous polymer membrane.
5. The bag of Claim 1 wherein the bag is sealable by heat-sealing.
6. The bag of Claim 1 , wherein the bag is sealable by a closure member.
7. The bag of Claim 1 , where the bag is sealable by folding and clipping the open end.
8. The bag of Claim 1 , wherein the sterile barrier layer is expanded, porous PTFE.
9. A process for freeze-drying a material which comprises:
(a) placing the material into the bag of Claim 1 ;
(b) closing or sealing the bag; and
(c) freeze-drying the material in the bag, allowing the water vapor to escape through the venting material.
PCT/US1996/000469 1995-04-07 1996-01-11 A freeze-drying bag and method for minimizing contamination of freeze-dried products WO1996031748A1 (en)

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US41958795A 1995-04-07 1995-04-07
US08/419,587 1995-04-07

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Cited By (18)

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WO2000036353A1 (en) * 1998-12-12 2000-06-22 University Of Strathclyde Method for drying a material in a container having one or more pierced holes
EP1236962A3 (en) * 2001-03-01 2002-12-04 National Agricultural Research Organisation (NARO) Freeze-dried product and process and apparatus for producing it
US6543155B2 (en) 2001-03-01 2003-04-08 National Agricultural Research Organization Freeze-dried product and process and apparatus for producing it
EP1958618A1 (en) * 2007-02-15 2008-08-20 Octapharma AG Method for freeze-drying with optimum reconstitution of biopolymers
WO2008130602A1 (en) * 2007-04-19 2008-10-30 E. I. Du Pont De Nemours And Company Container for freeze-drying
WO2015162273A1 (en) 2014-04-25 2015-10-29 Merck Sharp & Dohme Bv A method to dry multiple individual frozen bodies and a system for applying this method
WO2015191599A3 (en) * 2014-06-09 2016-04-07 Terumo Bct, Inc. Lyophilization
WO2016034719A3 (en) * 2014-09-04 2016-06-23 Petr Dejmek A process and a container for dehydration of a product
US9561893B2 (en) 2013-12-05 2017-02-07 Vascular Solutions, Inc. System and method for freeze-drying and packaging
WO2018202826A1 (en) 2017-05-04 2018-11-08 Project Pharmaceutics Gmbh Method for contamination-free freeze drying
GB2564481A (en) * 2017-07-14 2019-01-16 4D Pharma Leon S L U Process
DE102017121537A1 (en) 2017-09-18 2019-03-21 Rolf Lenhardt Bag and method for the contamination-free freeze-drying of a substance
US10793327B2 (en) 2017-10-09 2020-10-06 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
US10806665B2 (en) 2016-01-18 2020-10-20 Teleflex Life Sciences Limited System and method for freeze-drying and packaging
US10945959B2 (en) 2019-03-07 2021-03-16 Teleflex Life Sciences Limited System and method for freeze-drying and packaging
CN113164322A (en) * 2018-11-26 2021-07-23 豪夫迈·罗氏有限公司 Freeze-dried substance container and infusion set
EP3791121A4 (en) * 2018-05-07 2022-01-05 Merck Sharp & Dohme Corp. Lyophilization bag
US11604026B2 (en) 2019-03-14 2023-03-14 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system

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US10806665B2 (en) 2016-01-18 2020-10-20 Teleflex Life Sciences Limited System and method for freeze-drying and packaging
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GB2564481A (en) * 2017-07-14 2019-01-16 4D Pharma Leon S L U Process
DE102017121537A1 (en) 2017-09-18 2019-03-21 Rolf Lenhardt Bag and method for the contamination-free freeze-drying of a substance
US10793327B2 (en) 2017-10-09 2020-10-06 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
US11634257B2 (en) 2017-10-09 2023-04-25 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
EP3791121A4 (en) * 2018-05-07 2022-01-05 Merck Sharp & Dohme Corp. Lyophilization bag
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US11604026B2 (en) 2019-03-14 2023-03-14 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system
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