Vented vial method of minimizing contamination of freeze-dried products

• US 5,522,155 A
• Filed: 04/07/1995
• Issued: 06/04/1996
• Est. Priority Date: 08/19/1994
• Status: Expired due to Fees

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Jones, C. Bradford
• Primary Examiner(s): Sollecito, John M.
• Assistant Examiner(s): Gravini, Steve
• Application Number:
  US08/481,693
• Time in Patent Office: 424 Days
• Field of Search: 34/284, 34/286-88, 34/298, 34/300
• US Class Current: 34/286
• CPC Class Codes: A61J 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61J 1/1425 Snap-fit type
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: B65D 51/1616 by means of a filter
• CPC Class Codes: B65D 51/1683 by actuating a separate element in the container or closure
• CPC Class Codes: B65D 51/241 provided with freeze-drying means

Abstract

The present invention relates to a lyophilization process involving the use of a cap intended for vials or use therewith for containers that are subjected to lyophilization conditions where the cap, which may be resiliently helped in place or screwed on, includes a plug member movable within a fluid passageway in the cap, the plug member while positioned in the fluid passageway is movable between a first upwardly extending venting position and second downwardly engaging, sealing position whereby fluid from the vial or container is precluded from flowing through the fluid passageway in the cap.

Claims

1. A process for freeze drying a material which comprises:

(a) filling a vial or bottle with product under sterile conditions;

(b) attaching a cap or stopper to the mouth of the vial or bottle, in which the cap is shaped to form a vapor-tight seal with the mouth of the vial, and in which the cap or stopper has a venting port that comprises a passage in the cap or stopper, and a water vapor permeable, sterile barrier venting media located in the path of vapor travel through the venting port, and means for permitting the venting port to be opened or closed to the interior of the vial or bottle;

(c) moving the venting port means to the open position;

(d) freeze drying the product in the vial, allowing water vapor to escape through the venting media and the vent port;

(e) sealing the vent port by pressing down on the stopper.

2. The process of claim 1 in which, after step (c), the container is filled with a dry inert gas such as nitrogen.

3. A process for freeze drying a material which comprises:

(a) filling a vial or bottle with product under sterile conditions;

(b) attaching a cap to a mouth of said vial or bottle, said cap having;

(i) a resilient stopper having a fluid passageway extending therethrough with an inlet end and an upper outlet end, said inlet end adapted to communicate with an interior of said vial or bottle, said resilient stopper having an exterior surface for sealing engagement with a mouth of said vial or bottle;

(ii) a plug member movable within said fluid passageway, said plug member being movable between a first upwardly extending venting position and a second downwardly engaging sealing position whereby in said second position fluid is precluded from flowing through said fluid passageway; and

(iii) a water vapor permeable, sterile barrier venting media located in the path of vapor travel between the interior of said vial or bottle and the exterior of said vial or bottle, and being constructed and arranged to provide a barrier to passage of bacteria and particulate therethrough;

(c) moving said plug into said first venting position;

(d) freeze-drying the product in said vial or bottle with said plug in said first position, thereby allowing water vapor from said product to escape through the sterile barrier venting media; and

(e) moving said plug into said second sealing position by pressing down on said plug.

4. The process of claim 3 in which, after step (d), the container is filled with a dry inert gas such as nitrogen.