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Publication numberUS3454178 A
Publication typeGrant
Publication dateJul 8, 1969
Filing dateJan 10, 1966
Priority dateJan 10, 1966
Publication numberUS 3454178 A, US 3454178A, US-A-3454178, US3454178 A, US3454178A
InventorsCharles E Bender, Martin C Parkinson
Original AssigneeCharles E Bender, Martin C Parkinson
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Sterile cap for a freeze-drying container and method of freeze-drying materials under sterile conditions
US 3454178 A
Abstract  available in
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Claims  available in
Description  (OCR text may contain errors)

y 8, 1959 .c. E. BENDER ET AL 3,454,178

STERILE CAP FOR A FREEZE-DRYING CONTAINER AND METHOD OF FREEZE-DRYING MATERIALS UNDER STERILE CONDITIONS Filed Jan. 1 0, 1966 V IN V EN TOR. (HA/u 5 E. 5540511 MA/erI/v c. PARK/N50!!! United States Patent 3,454,178 STERILE CAP FOR A FREEZE-DRYING CON- TAINER AND '"METHOD OF FREEZE-DRYING MATERIALS UNDER STERILE CONDITIONS Charles E. Bender, 61 Millrock Road, New Paltz, N.Y. 12561, and Martin C. Parkinson, Maple House, Beacon, N.Y. 12508 Filed Jan. 10, 1966, Ser. No. 529,598 Int. Cl. B65a 51/00, 51/08, 51/14 U.S. Cl. 215-37 ABSTRACT OF THE DISCLOSURE A cap and stopper assembly to maintain a sterile condition in a container during freeze-drying and stoppering.

This invention relates to a sterile cap for a freeze-drying container and a method of freeze-drying materials under sterile conditions.

The freeze-drying technique has been applied successfully to the freeze-drying of various biological materials such as, for example, vaccines and the like.

In freeze-drying material of this nature it is, of course, necessary to conduct the process under sterile conditions. If foreign bacteria should enter the container and contaminate the product the biological consequences would be, of course, extremely serious. The freeze-dried vaccines and the like are injected into a patients body under sterile conditions.

Prior to the instant invention it was a rather diflicult procedure to freeze-dry such materials under sterile conditions. The freeze-drying process had to be carried out in a completely sterile room. Such conditions are diflicult to maintain. Furthermore the packaging of the material also had to be carried out in such a completely sterile room. As a result, while it was heretofore successfully possible to conduct freeze-drying of biological materials under such sterile conditions the techniques involved were costly, time consuming, and expensive.

Peculiarly, in contamination of products, bacteria do not contaminate unless they fall directly into the product. Bacteria are, of course, principally airborne. Hence, unless there are foreign conditions agitating the air, such as wind or the like, bacteria will not contaminate a container if the top of the container is covered.

The instant invention involves a structure which permits freeze-drying of biological material under conditions wherein total sterility of the room need not be obtained. The invention involves both the method of carrying out such process and apparatus for accomplishing the same.

The above constitutes a brief description of the instant invention and some of the objects and advantages thereof. Other objects and advantages of this invention will become apparent to the reader of this specification as the description proceeds.

The invention will now be described by reference to the accompanying drawings which are made a part of this specification.

FIG. 1 is a perspective view showing a container which is utilized for the freeze-drying of biological material. The closure means which are used to maintain sterility after the container is capped are shown in the partially open position that said means assume while freeze-drying is taking place.

FIG. 2 is a view similar to that of FIG. 1 but showing the closure means closing the mouth of the container and with the cap portion crimped over the container so that sterility is maintained until the material is to be used.

FIG. 3 is a cross-sectional view taken along lines 33 of FIG. 1.

1 Claim ice The invention will now befurther described by reference to the specific form thereof shown in the accompanying drawings. In this connection, however, the reader is cautionedto notethat thespecific form of this invention as set forth in the instant specification is for illustrative purposes and for purposes of example only. Various changes and modifications may obviously be made within the spirit and scope of this invention and would occur to those skilled in this art.

Now referring to the specific form of the instant in vention as set forth in the drawings a freeze-drying container assembly 11 comprises a receptacle portion 12 which is provided with a circular mouth 13 thereupon and a circumferential outwardly extending flange 14 carried by the mouth. A resilient stopper 15 is selectively disposable within mouth 13 of portion 12 either in stoppered (FIG. 2) relationship or partially stoppered (FIG. 1) relationship. A plurality of longitudinal grooves 16 and 17 are provided within stopper 15'. Stopper 15 includes an outwardly and upwardly tapered body portion 18 having a smallest diameter 19 and a largest diameter 20. The smallest diameter 19' is no greater than the diameter of mouth 13- and the greatest diameter is greater than the diameter of mouth 13. Thus the body portion of stopper 15 can firmly close the mouth of the container.

A holding portion 22 is provided on stopper 15 which is carried by the body portion thereof and is adapted to overlie mouth 13 of receptacle portion 12.

A cap 23 is provided with an interior perimetral recess 24 within which holding portion 22 of stopper 15 is supported. Cap 23 is also formed with a perimetrally disposed downwardly depending portion 25 which is adapted to overlie and embrace mouth 13 of receptacle 12. Downwardly depending portion 25 is also adapted to be crimped under flange 14 as shown in FIG. 2.

With the foregoing specific description the operation of this invention may now be explained.

Biological material 30 is placed within receptacle 12 under sterile conditions. The stopper is placed within the mouth of the freeze-drying receptacle in the position shown in FIG. 1 and the device is attached to a freeze-drying apparatus of conventional type. At this point sterile conditions need no longer be maintained since the cap portion of the stopper overlies the container and prevents further contamination. The freeze-drying process is now continued until the biological material within the container is freeze-dried. At that point the stopper is placed in the position shown in FIG. 2, the cap is crimped beneath the flange, and the container may then be sold. Sterile conditions will be maintained until the biological material within the container is actually used.

The foregoing sets forth the manner in which the objects of this invention are achieved.

We claim:

1. A sterile closure arrangement particularly adapted for use in maintaining sterility of a container contents during freeze-drying thereof, said closure arrangement comprising a resilient stopper having a tapered body portion adapted for selective disposition in the mouth of a container, said body portion having a diametrically disposed slot extending axially of said body portion and being operative to permit communication with the interior of the container when said stopper is partially inserted in the mouth thereof, said stopper including a flange of greater diameter than said body portion and adapted to overlie the mouth of said container to assist in sealing said container when said body portion is completely inserted in said mouth, and a sterile cap covering said flange on said body portion, said sterile cap including a top and a perimetrically disposed, downwardly depending skirt, and means in said cap to-embrace and retain said flange on said body portion to provide a sterile shield 3 4 during freeze-drying of the contents and stoppering of 2,927,709 3/ 1960 Hoflman et a1. 215-47 said container.

References Cited JOSEPH R. LECLAIR, Primary Examiner. UNITED STATES PATENTS CL 2,734,649 2/1956 Callahan et a1. 215-37 5 21548 2,792,678 5/1957 Baldwin et a1. 53101

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2734649 *Apr 5, 1952Feb 14, 1956 Moistureproof vial closure
US2792678 *Dec 3, 1953May 21, 1957Baldwin Jr Earl MApparatus for capping vacuum bottles
US2927709 *Jul 7, 1959Mar 8, 1960Faultless Rubber CoBottle stopple
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US4552278 *Oct 30, 1984Nov 12, 1985E. I. Du Pont De Nemours And CompanyCrimpable capping assembly for a centrifuge tube
US5522155 *Apr 7, 1995Jun 4, 1996W. L. Gore & Associates, Inc.Vented vial method of minimizing contamination of freeze-dried products
US5596814 *Nov 6, 1995Jan 28, 1997W. L. Gore & Associates, Inc.Vented vial stopper for processing freeze-dried products
US5732837 *Mar 1, 1996Mar 31, 1998W. L. Gore & Associates, Inc.Vented vial closure member for freeze-drying which minimizes contamination of freeze-dried products
US6566144 *Mar 27, 2000May 20, 2003Atrix LaboratoriesCover plate for use in lyophilization
US6610252 *Jan 22, 2002Aug 26, 2003Atrix Laboratories, Inc.System for use in lyophilization comprising delivery containers and a cover plate
US6722054Jul 20, 2001Apr 20, 2004Atrix Laboratories, Inc.Process and delivery container for lyophilizing active agent
US6907679Mar 17, 2003Jun 21, 2005Qlt Usa, Inc.Method for lyophilizing an active agent
US7467482Apr 6, 2005Dec 23, 2008Qlt Usa, Inc.Method for lyophilizing an active agent
US7520670Apr 26, 2005Apr 21, 2009John Jeffrey SchwegmanWireless temperature sensing system for lyophilization processes
US8002734Aug 14, 2006Aug 23, 2011Boehringer Ingelheim International GmbhDual chamber container and process for its filling up
US8096971Aug 14, 2006Jan 17, 2012Boehringer Ingelheim International GmbhDual chamber container for lyophilization, process for the filling up and use thereof
US8171652Jun 27, 2011May 8, 2012Medical Instill Technologies, Inc.Penetrable and resealable lyophilization method
US8226598Aug 5, 2003Jul 24, 2012Tolmar Therapeutics, Inc.Coupling syringe system and methods for obtaining a mixed composition
US8272411Aug 3, 2009Sep 25, 2012Medical Instill Technologies, Inc.Lyophilization method and device
US9003676Jun 17, 2008Apr 14, 2015Tolmar Therapeutics, Inc.Method for lyophilizing an active agent
US9222728 *Apr 24, 2007Dec 29, 2015Medinstill Development LlcPenetrable and resealable lyophilization device
US9278790 *Jun 10, 2014Mar 8, 2016The United States Of America As Represented By The Secretary Of The NavyLyophilization tray lid
US20030195489 *Jun 6, 2003Oct 16, 2003Atrix Laboratories, Inc.Coupling syringe system and methods for obtaining a mixed composition
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US20050193586 *Apr 6, 2005Sep 8, 2005Atrix Laboratories, Inc.Method for lyophilizing an active agent
US20060239331 *Apr 26, 2005Oct 26, 2006Schwegman John JWireless temperature sensing system for lyophilization processes
US20070060875 *Aug 14, 2006Mar 15, 2007Stefan BassarabDual chamber container without by-pass in the cylindrical body
US20070060876 *Aug 14, 2006Mar 15, 2007Stefan BassarabDual chamber container without by-pass
US20070060877 *Aug 14, 2006Mar 15, 2007Stefan BassarabDual chamber container for lyophilization, process for the filling up and use thereof
US20070129673 *Aug 14, 2006Jun 7, 2007Stefan BassarabDual chamber container and process for its filling up
US20080039773 *Apr 24, 2007Feb 14, 2008Daniel PyNeedle penetrable and laser resealable lyophilization device and related method
US20080244923 *Jun 17, 2008Oct 9, 2008Qlt Usa, Inc.Method for lyophilizing an active agent
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US20150353248 *Jun 10, 2014Dec 10, 2015Derrell Craig McPhersonLyophilization Tray Lid
DE102013003851B3 *Mar 6, 2013Mar 6, 2014Hof Sonderanlagenbau GmbhStopper, particularly lyo-stopper for sealing vial filled with medicinal products to be freeze-dried in sterile room, has particle barrier provided in flow channel, which prevents discharge of particles of product material contained in vial
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Classifications
U.S. Classification215/277, D09/439, 215/DIG.300
International ClassificationB65D51/00, B65D51/24
Cooperative ClassificationB65D51/241, Y10S215/03, F26B5/06, B65D51/002
European ClassificationB65D51/00B, B65D51/24A, F26B5/06