Syringe containing frozen vaccine

• US 4,018,222 A
• Filed: 05/13/1975
• Issued: 04/19/1977
• Est. Priority Date: 02/10/1975
• Status: Expired due to Term

• Current Assignee: Merck & Co., Inc.
• Original Assignee: Merck & Co., Inc.
• Inventors: Hilleman, Maurice R., McAleer, William J.
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US05/577,244
• Time in Patent Office: 707 Days
• Field of Search: 128/216, 128/215, 128/217, 128/218, 128/272, 128/214, 128/221, 128/DIG. 24, 206/364-370, 206/438-441, 229/3.5 MF
• US Class Current: 604/113
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/288 by piercing without internal pressure increase A61M5/283 takes precedence

Abstract

Vaccine delivery system wherein an aqueous vaccine diluted to human dosage concentration is loaded into presterilized single dosage syringes having a squeezable body portion and wherein a plurality of these syringes are sealed inside a bag and the contents of the syringes are frozen to preserve the titer of the vaccine.

Claims

1. A vaccine delivery system suitable for human administration comprising a single dosage hypodermic syringe having a container portion made of a plastic material which is resiliently flexible at room temperature and a needle portion comprising a hollow sharp needle extending from the plastic container portion to convey fluids from within the container out through the tip of the needle when the needle is inserted under the skin and the container is squeezed, an aqueous vaccine diluted to a concentration suitable for human administration and sealed within the container, the vaccine being in the frozen state at a temperature of from about -10°

C to about -20°

C, whereby the vaccine is preserved for storage and shipment and the syringe is protected from leakage during storage and shipment.

2. A vaccine delivery system according to claim 1 wherein said container portion is composed of low density polyethylene.

3. In combination, a plurality of hypodermic syringes each comprising a tubular container portion of plastic material which is resiliently flexible at room temperature and a needle portion comprising a hollow sharp needle extending out from the container portion, a single dosage of an aqueous vaccine, diluted to a concentration suitable for human administration, contained in each tubular container portion and sealed therein, said vaccine being frozen at a temperature of from about -10°

C to about -20°

C and a gas and light impervious bag enveloping said plurality of syringes and sealing said syringes therein.

4. A combination according to claim 3 wherein said gas and light impervious bag is of aluminum foil.

5. A combination according to claim 3 wherein said syringes include removable dust covers enveloping the outer end of their needle portion.

6. A method of preparing vaccine for delivery storage and administration comprising the steps of filling tubular flexible syringes having a plastic container portion which is resiliently flexible at room temperature and a hollow sharp needle extending from the plastic container with an aqueous vaccine diluted to human administration concentration, each syringe containing a single dose of the vaccine, sealing the syringes closed, enveloping and sealing a plurality of the filled and sealed syringes inside a gas and light impervious bag, subjecting the filled bag to a temperature low enough to freeze the vaccine and maintaining the vaccine in the bag during storage and shipment at a temperature of from about -10°

C to about -20°

C.

7. A method according to claim 6 further including the step of subjecting the syringe to an ethylene oxide atmosphere prior to filling.

8. A method according to claim 7 further including the step of subjecting the syringe to a vacuum to purge the syringe of ethylene oxide.

9. A method according to claim 6 wherein said filled bag is subjected to a temperature low enough to freeze the vaccine by placing said bag in liquid nitrogen vapors.

10. A method according to claim 6 wherein the bag is maintained at said temperature by placing it in dry ice.

11. A method according to claim 6 wherein the bag is maintained at said temperature by mechanical refrigeration.