Tamperproof container

• US 4,306,357 A
• Filed: 02/04/1980
• Issued: 12/22/1981
• Est. Priority Date: 06/05/1978
• Status: Expired due to Term

• Current Assignee: Merck & Co., Inc.
• Original Assignee: Merck & Co., Inc.
• Inventors: Villarejos, Miguel
• Primary Examiner(s): Camby, John J.
• Application Number:
  US06/118,141
• Time in Patent Office: 687 Days
• Field of Search: 34/5, 215/305
• US Class Current: 34/284
• CPC Class Codes: B65D 51/241 provided with freeze-drying means
• CPC Class Codes: F26B 5/06 the process involving freezing

Abstract

An improved tamperproof container for lyophilized material wherein the container comprises a vial having flange about its opening. Below the flange, but spaced apart therefrom is a shoulder to define an indented neck therebetween. The opening is sealed with a pierceable stopper. An overcap extends over the flange and about the neck to form a skirt about the neck. The skirt has at least a portion thereof extending inwardly in gripping reaction with the neck and limited in removal by contact with the underside of the flange whereby the cap cannot be removed without destroying its structural integrity.

Claims

1. A method for sealing a tamperproof container housing a lyophilized material of the type having a container portion and a cap assembly portion, the container portion having an opening, a neck below the opening, in the neck a flange about the opening and a shoulder spaced apart from the flange to define therebetween a groove;

the cap extending over the flange and about the neck to form a skirt, a portion of the skirt extending inwardly in gripping relation to the groove, said skirt having a plurality of ratchets attached to the wall of the skirt and extending upwardly and inwardly from said skirt whereby when the cap assembly is closed the overcap is limited in its removal by the flange and can only be removed with the destruction of the structural integrity of the package;

a sealing stopper in the opening, and the stopper having a capping flange portion and a stem portion;

the capping flange portion sealingly engaged with the flange of the container;

the stopper having in the stem portion ventilation ribs so that when the capping flange is in spaced-apart relation from the container flange, the ventilation ribs allowing fluid communication between the interior of the container and the exterior;

the sealed portion of the skirt extending inwardly to engage the juncture of the groove and the container flange;

the top of the cap engaging the capping flange in sealing relation; and

a sealable opening in the overcap for inroducing a syringe needle therethrough to introduce reconstituting liquid and for withdrawing the biological material after reconstitution comprising fitting the cap assembly on a container portion filled with a biological material to be lyophilized in a position such that the ratchets are above the flange, lyophilizing the biological material in the container, and applying a downward pressure until the ratchets pass over the flange and become seated in the groove.

2. A method for sealing a tamperproof container housing a lyophilized material of the type having a container portion and a cap assembly portion, the container portion having an opening, a neck below the opening, in the neck a flange about the opening and a shoulder spaced apart from the flange to define therebetween a groove;

the cap extending over the flange and about the neck to form a skirt, a portion of the skirt extending inwardly in gripping relation to the groove, said skirt having a plurality of ratchets attached to the wall of the skirt and extending upwardly and inwardly from said skirt whereby when the cap assembly is closed the overcap is limited in its removal by the flange and can only be removed with the destruction of the structural integrity of the package;

comprising fitting the cap assembly on a container portion filled with a biological material to be lyophilized, in a position such that the ratchets are above the flange, lyophilizing the biological material in the container, and applying a downward pressure until the ratchets pass over the flange and become seated in the groove.