WO1995027180A1 - Improved method for minimizing contamination of freeze-dried products - Google Patents
Improved method for minimizing contamination of freeze-dried products Download PDFInfo
- Publication number
- WO1995027180A1 WO1995027180A1 PCT/US1994/007161 US9407161W WO9527180A1 WO 1995027180 A1 WO1995027180 A1 WO 1995027180A1 US 9407161 W US9407161 W US 9407161W WO 9527180 A1 WO9527180 A1 WO 9527180A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- container
- freeze
- water vapor
- venting media
- sterile
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 27
- 238000011109 contamination Methods 0.000 title abstract description 13
- 239000000463 material Substances 0.000 claims abstract description 39
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 31
- 238000013022 venting Methods 0.000 claims abstract description 27
- 238000004108 freeze drying Methods 0.000 claims abstract description 24
- 230000004888 barrier function Effects 0.000 claims abstract description 18
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000001301 oxygen Substances 0.000 claims abstract description 8
- 229910052760 oxygen Inorganic materials 0.000 claims abstract description 8
- 230000005540 biological transmission Effects 0.000 claims abstract description 5
- 238000007789 sealing Methods 0.000 claims abstract description 5
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 7
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 7
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 6
- -1 polytetrafluoroethylene Polymers 0.000 claims description 5
- 230000002209 hydrophobic effect Effects 0.000 claims description 4
- 239000011261 inert gas Substances 0.000 claims description 3
- 229910052757 nitrogen Inorganic materials 0.000 claims description 3
- 238000004806 packaging method and process Methods 0.000 abstract description 3
- 239000011148 porous material Substances 0.000 description 7
- 238000001035 drying Methods 0.000 description 4
- 238000012792 lyophilization process Methods 0.000 description 3
- 230000035515 penetration Effects 0.000 description 3
- 230000001580 bacterial effect Effects 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 230000003647 oxidation Effects 0.000 description 2
- 238000007254 oxidation reaction Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 230000003749 cleanliness Effects 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000011344 liquid material Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000012858 packaging process Methods 0.000 description 1
- 239000013618 particulate matter Substances 0.000 description 1
- 229920006254 polymer film Polymers 0.000 description 1
- 229920005597 polymer membrane Polymers 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
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
Landscapes
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Packages (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
This invention provides a process that protects the freeze-dried material from contamination through the steps of freeze-drying, final packaging, shipping, and storing, until the material is finally ready to be used by the ultimate consumer. The process comprises: (a) placing the material into a container in which at least a portion of a side thereof is made of a water vapor permeable, sterile barrier venting media; (b) sealing the container; (c) freeze-drying the material in the container, allowing the water vapor to escape through the venting media; (d) covering the venting media with a cover that is a barrier to water vapor and oxygen transmission; and (e) maintaining the material in the container until it is ready for use.
Description
TITLE OF THE INVENTION IMPROVE METHOD FOR MINIMIZING CONTAMINATION OF FREEZE-DRIED PRODUCTS FIELD OF THE INVENTION This invention provides a process for lyophilizing and storing material More particularly, it relates to a process in which the material is protected from contamination by a sterile-barrier package from the time it is introduced to the lyophilization process to the time it is used by the ultimate customer. BACKGROUND OF THE INVENTION Freeze-drying or lyophilization, is used for the preservation of a wide variety of foods, pharmaceuticals, and biological products. Extreme care must be taken in the handling and processing of many of these products to minimize the opportunities for contamination. For example, freeze-drying equipment is often steam-sterilized between batches, and in many cases the entire operating area in which the equipment is located may be ouffitted as a sterile clean room to minimize the exposure of product to contaminants as it is being transported to and from the freeze-drier. In many cases, product must be re-packaged after freeze-drying, presenting yet another handling step that represents an opportunity to introduce contamination. Many freeze-dry processes involve presenting open containers of material to the freeze-dryer. Containers were kept open until the freeze-dry process was completed to allow a path for water vapor to be removed from the product. This practice, however, presented opportunity for contamination. Attempts to address this problem by making large investments in clean working areas and in maintaining cleanliness and sterility of their freeze-drying equipment between manufacturing nuns have been made. European Patent No. 343,596 describes improvements to this process. The improvement is the use of a sterile-barrier container for the freeze-dry process itself. In this improvement, material is placed in a vented, sterile barrier container, and is then freeze-dried. After freeze-drying, however, material is removed from the container and re-packaged, introducing another opportunity for contamination. In U.S. Patent Nos. 4,973,327 and 5,257,983, rigid containers are designed to allow water vapor to be withdrawn through a port, and the port is then sealed after lyophilization so that the container can be used as the ultimate delivery vehicle. This eliminates the handling step of re-packaging after lyophilization, but stiil leaves open the possibility for contamination in the freeze-dry operation itself. Furthermore, restriction of water vapor evacuation through a specific port area may place a restriction on the productivity of the freeze-dry process. SUMMARY OF THE INVENTION It is a purpose of this invention to provide a process that protects the freeze-dried material from contamination through the steps of freeze-drying, final packaging, shipping, and storing, until the material is finally ready to be used by the ultimate consumer. The process comprises: (a) placing the material into a container in which at least a portion of a side thereof is made of a water vapor permeable, sterile banier venting media; (b) sealing the container; (c) freeze-drying the material in the container, allowing the water vapor to escape through the venting media; (d) covering the venting media with a cover that is a barrier to water vapor and oxygen transmission; and (e) maintaining the material in the container until it is ready for use. Optionally, after step (c), the container can be filled with dry, sterile, inert gas such as nitrogen. Step (d) may involve providing an over-seal over the venting media itself, or it may involve placing the entire container inside a water and oxygen vaporbarrier outer package. By sterile barrier is meant a material that can be shown to resist penetration by bacteria. BRIEF DESCRIPTION OF THE DRAWINGS The figure shows an example of a container useful in the process of the invention. Figure Ia depicts a vial that has been filled with material and closed with a vented cap prior to lyophilization. Figure 1 b depicts a vial that has a vapor-impermeable seat placed over the vent in the cap after lyophilization. DETAILED DESCRIPTION OF THE INVENTION In this invention, a water vapor-permeable, sterile barrier venting media is employed as an integral part of the container design. It can span an opening on a side of the container, whether a jar, vial, or envelope, or it can be located in the closure member of the container, such as in a lid for a jar or vial or an entire container can be made of the media. The material is placed inside the vented, sterile-banier container, and the container is sealed, prior to lyophilization. The sterile-barrier container remains sealed, and thus provides protection of the contents from contamination, from that point forward. The material and the container are placed in the freeze-dryer and subjected to the lyophilization process. Water vapor passes out of the container through the vent 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. Once the material is freezedried, it is protected from rehydration or oxidation by sealing the container with a material that provides an effective banier to water vapor and oxygen transmission. Depending on the specific package design, this may involve providing an over-seal over the vent area itself, or it may involve placing the entire sterile-barrier container inside a vapor-barrier outer package. In any case the sterile barrier properties of the vented container are not jeopardized in the final packaging process. The freeze-dried material thus has a welldefined level of protection from contamination through every handling step in its life, from lyophilization to ultimate delivery to the user. A representative container is shown in the Figure. Vial 10 contains liquid material 11 to be freeze-dried. Lid 12 is equipped with vent 13, which is made of a water vapor-permeable sterile barrier venting media such as a 0.2 micron nominal pore size stretched polytetrafluoroethylene (PTFE) membrane with an appropriate non-woven support backing (available from W. L. Gore & Associates, Inc.). In operation, material 11 is placed inside vial 10 under sterile conditions and the lid is placed on the vial. During lyophilization, water vapor exits through venting media 13. After lyophilization, a seal 14, which has been selected for its oxygen and water vapor banier properties (such as an adhesive-backed metal foil) is applied over the vent as in Figure Ib thus preventing degradation of freeze-dried material 15 by oxidation or rehydration during storage and handling. Instead of a vial, a vented bag or pouch can be used. The entire bag or a portion of the bag can be made of the water vapor-permeable sterile barrier venting media, to maximize the available area for water vapor removal in the lyophilization process. The procedure is much the same as with the vial. The bag is filled with material, sealed, and placed in the freeze-dryer. The material is freeze-dried inside the sealed bag, the water vapor escaping through the water vapor-permeable area. After freeze-drying, the vented bag can then be placed in an oxygen and water vapor-impermeable outer bag, which is then sealed to protect the freeze-dried material from degradation during storage and handling. Of course, if the bag is only partly made of the barrier material, only that area need be sealed. In practice, the venting media can be any venting media that is water vapor-permeable but which provides effective resistance to bacterial penetration. Sterile papers, non-woven polymer films such as a polyolefin, e.g. spun bonded TyvekS) and porous polymer membranes such as expanded porous polytetrafluoroethylene are examples. Best performance will be obtained with venting media that are hydrophobic, as such materials 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 effective pore size. Pore sizes in the 2.0 to 3.0 micrometers 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 polytetrafluoroethylene, which has a microstructure of nodes interconnected with fibrils, nominal pore sizes of 0.1 micrometer, or 0.2 or up to 3 or more micrometers are useful. On the other hand, smaller nominal pore sizes in a given media will also yield higher resistance to vapor flow, which can effect productivity in lyophilization. Stretched, porous PTFE is a preferred venting media based on its 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.
Claims
CLAIMS:
1. A process for freeze-drying and storing material which comprises:
(a) placing the material into a container in which at least a portion of a
side thereof is made of a water vapor permeable, sterile barrier
venting media;
(b) sealing the container;
(c) freeze-drying the material in the container, allowing the water
vapor to escape through the venting media;
(d) covering the venting media with a cover that is a barrier to water
vapor and oxygen transmission; and
(e) maintaining the material in the container until it is ready for use.
2. The process of Claim 1 in which, after step (c), the container is filled with
dry, sterile, inert gas, nitrogen.
3. The process of Claim 1 in which the venting media is, additionally,
hydrophobic.
4. The process of Claim 1 in which the sterile barrier venting media is made
of stretched, porous polytetrafluoroethylene.
5,. The process of Claim 1 in which the container is in the form of a vial with
a vented lid.
6. The process of Claim 1 in which the container is in the form of a bag.
7. The process of Claim 1 in which the container is in the form of a box.
8. The process of Claim 1 in which the entire container is formed of the
venting media.
9. A process for freeze-drying and storing material which comprises:
(a) placing the material into a container having an opening, and which
has a cap for covering said opening that has at least a portion
thereof made of a water vapor-permeable, sterile-barrier venting
media;
(b) sealing the container by securely attaching the cap over said
opening;
(c) freeze-drying the material in the container allowing the water vapor
to escape through the venting media;
(d) covering the venting media with a cover that provides a barrier to
water vapor and oxygen transmission; and
(e) maintaining the material in the container until it is ready for use.
10. The process of Claim 9 in which, after step (c), the container is filled with
dry, sterile, inert gas, nitrogen.
11. The process of Claim 9 in which the venting media is, additionally,
hydrophobic.
12. The process of Claim 9 in which the sterile barrier venting media is made
of stretched, porous polytetrafluoroethylene.
13,. The process of Claim 9 in which the container is in the form of a vial with
a vented lid.
14. The process of Claim 9 in which the container is in the form of a bag.
15. The process of Claim 9 in which the container is in the form of a box.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU73560/94A AU7356094A (en) | 1994-04-04 | 1994-06-24 | Improved method for minimizing contamination of freeze-dried products |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US22215394A | 1994-04-04 | 1994-04-04 | |
| US08/222,153 | 1994-04-04 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO1995027180A1 true WO1995027180A1 (en) | 1995-10-12 |
Family
ID=22831084
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1994/007161 WO1995027180A1 (en) | 1994-04-04 | 1994-06-24 | Improved method for minimizing contamination of freeze-dried products |
Country Status (2)
| Country | Link |
|---|---|
| AU (1) | AU7356094A (en) |
| WO (1) | WO1995027180A1 (en) |
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997011155A1 (en) * | 1995-09-22 | 1997-03-27 | Government Of The United States Of America, Represented By The Secretary Of The Department Of Health And Human Services | Container for drying biological samples, method of making such container, and method of using same |
| 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 |
| US6312648B1 (en) | 1998-01-12 | 2001-11-06 | The United States Of America As Represented By The Department Of Health And Human Services | Applicator system |
| 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 |
| EP2157387A1 (en) * | 2008-08-19 | 2010-02-24 | DRK-Blutspendedienst West gemeinnützige Gesellschaft mit beschränkter Haftung | A non-collapsible and non-foldable container for lyophilization of a product |
| 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 |
| 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 |
| CN113736134A (en) * | 2021-11-08 | 2021-12-03 | 国家电投集团氢能科技发展有限公司 | Modified expanded polytetrafluoroethylene, preparation method thereof, composite ion exchange membrane and application thereof |
| US11536512B1 (en) * | 2021-09-16 | 2022-12-27 | Thomas John Harkins, JR. | Apparatus and method for lyophilization |
| US11604026B2 (en) | 2019-03-14 | 2023-03-14 | Terumo Bct Biotechnologies, Llc | Lyophilization loading tray assembly and system |
| US11723870B1 (en) | 2022-01-31 | 2023-08-15 | Thomas John Harkins, JR. | Assembly, apparatus and method for lyophilization |
| US11957790B1 (en) | 2022-01-31 | 2024-04-16 | Thomas John Harkins, JR. | Combination lyophilization and dispensing syringe assembly and methods of using same |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB995930A (en) * | 1961-11-28 | 1965-06-23 | Leybold Hochvakuum Anlagen | Method of freeze drying |
| GB1259039A (en) * | 1969-09-25 | 1972-01-05 | ||
| EP0343596A2 (en) * | 1988-05-26 | 1989-11-29 | Roche Diagnostics GmbH | Container for freeze drying under sterile conditions |
| US4973327A (en) * | 1989-11-01 | 1990-11-27 | Cryopharm | Blood bag for lyophilization |
| US5257983A (en) * | 1991-04-12 | 1993-11-02 | Cryopharm Corporation | Blood bag for lyophilization |
-
1994
- 1994-06-24 AU AU73560/94A patent/AU7356094A/en not_active Abandoned
- 1994-06-24 WO PCT/US1994/007161 patent/WO1995027180A1/en active Application Filing
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB995930A (en) * | 1961-11-28 | 1965-06-23 | Leybold Hochvakuum Anlagen | Method of freeze drying |
| GB1259039A (en) * | 1969-09-25 | 1972-01-05 | ||
| EP0343596A2 (en) * | 1988-05-26 | 1989-11-29 | Roche Diagnostics GmbH | Container for freeze drying under sterile conditions |
| US4973327A (en) * | 1989-11-01 | 1990-11-27 | Cryopharm | Blood bag for lyophilization |
| US5257983A (en) * | 1991-04-12 | 1993-11-02 | Cryopharm Corporation | Blood bag for lyophilization |
Cited By (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997011155A1 (en) * | 1995-09-22 | 1997-03-27 | Government Of The United States Of America, Represented By The Secretary Of The Department Of Health And Human Services | Container for drying biological samples, method of making such container, and method of using same |
| US5958778A (en) * | 1995-09-22 | 1999-09-28 | The United States Of America As Represented By The Department Of Health And Human Services | Container for drying biological samples, method of making such container, and method of using same |
| US6503455B1 (en) | 1995-09-22 | 2003-01-07 | The United States Of America As Represented By The Department Of Health And Human Services | Container for dying biological samples, method of making such container, and method of using same |
| US6312648B1 (en) | 1998-01-12 | 2001-11-06 | The United States Of America As Represented By The Department Of Health And Human Services | Applicator system |
| 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 |
| US8518452B2 (en) | 2007-02-15 | 2013-08-27 | Octapharma Ag | Method for stabilizing blood plasma components in a lyophilizate using carbon dioxide and phosphoric acid |
| EP2431024A1 (en) | 2007-02-15 | 2012-03-21 | Octapharma AG | Method for stabilising blood plasma contents in a lyophilisate |
| 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 |
| EP2157387A1 (en) * | 2008-08-19 | 2010-02-24 | DRK-Blutspendedienst West gemeinnützige Gesellschaft mit beschränkter Haftung | A non-collapsible and non-foldable container for lyophilization of a product |
| US10882654B2 (en) | 2013-12-05 | 2021-01-05 | Teleflex Life Sciences Limited | System and method for freeze-drying and packaging |
| US9561893B2 (en) | 2013-12-05 | 2017-02-07 | Vascular Solutions, Inc. | System and method for freeze-drying and packaging |
| US10377520B2 (en) | 2013-12-05 | 2019-08-13 | Teleflex Innovations S.A.R.L. | System and method for freeze-drying and packaging |
| US11279510B2 (en) | 2013-12-05 | 2022-03-22 | Teleflex Life Sciences Limited | System and method for freeze-drying and packaging |
| WO2016034719A3 (en) * | 2014-09-04 | 2016-06-23 | Petr Dejmek | A process and a container for dehydration of a product |
| US10806665B2 (en) | 2016-01-18 | 2020-10-20 | Teleflex Life Sciences Limited | System and method for freeze-drying and packaging |
| US11634257B2 (en) | 2017-10-09 | 2023-04-25 | Terumo Bct Biotechnologies, Llc | Lyophilization container and method of using same |
| US10793327B2 (en) | 2017-10-09 | 2020-10-06 | Terumo Bct Biotechnologies, Llc | Lyophilization container and method of using same |
| US10945959B2 (en) | 2019-03-07 | 2021-03-16 | Teleflex Life Sciences Limited | System and method for freeze-drying and packaging |
| US11740019B2 (en) | 2019-03-14 | 2023-08-29 | Terumo Bct Biotechnologies, Llc | Lyophilization loading tray assembly and system |
| US11604026B2 (en) | 2019-03-14 | 2023-03-14 | Terumo Bct Biotechnologies, Llc | Lyophilization loading tray assembly and system |
| US11609043B2 (en) | 2019-03-14 | 2023-03-21 | Terumo Bct Biotechnologies, Llc | Lyophilization container fill fixture, system and method of use |
| US11609042B2 (en) | 2019-03-14 | 2023-03-21 | Terumo Bct Biotechnologies, Llc | Multi-part lyophilization container and method of use |
| US11747082B2 (en) | 2019-03-14 | 2023-09-05 | Terumo Bct Biotechnologies, Llc | Multi-part lyophilization container and method of use |
| US11815311B2 (en) | 2019-03-14 | 2023-11-14 | Terumo Bct Biotechnologies, Llc | Lyophilization container fill fixture, system and method of use |
| US11994343B2 (en) | 2019-03-14 | 2024-05-28 | Terumo Bct Biotechnologies, Llc | Multi-part lyophilization container and method of use |
| US11536512B1 (en) * | 2021-09-16 | 2022-12-27 | Thomas John Harkins, JR. | Apparatus and method for lyophilization |
| CN113736134A (en) * | 2021-11-08 | 2021-12-03 | 国家电投集团氢能科技发展有限公司 | Modified expanded polytetrafluoroethylene, preparation method thereof, composite ion exchange membrane and application thereof |
| US11723870B1 (en) | 2022-01-31 | 2023-08-15 | Thomas John Harkins, JR. | Assembly, apparatus and method for lyophilization |
| US11890379B2 (en) | 2022-01-31 | 2024-02-06 | Thomas John Harkins, JR. | Lyophilization syringe |
| US11957790B1 (en) | 2022-01-31 | 2024-04-16 | Thomas John Harkins, JR. | Combination lyophilization and dispensing syringe assembly and methods of using same |
Also Published As
| Publication number | Publication date |
|---|---|
| AU7356094A (en) | 1995-10-23 |
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