Processing Cap Assembly for Isolating Contents of a Container

Abstract

Improved cap assemblies which isolate materials in containers, e.g., bottles, vials, multi-vial trays, multi-well trays, etc., during processes while permitting vapor to pass into or out of the container, such as during freeze drying and the like, and facilitate subsequent closure of the container to cease such vapor passage (e.g., stoppering, etc.). The cap assembly optimizes containment of solute, prevents contamination, is easy to use and is readily compatible with validated industrial drying processes.

1 . A removable processing cap assembly for isolation of contents in a stoppered container, comprising:
 a cap having a top and a bottom, said cap comprising a housing with a sealing perimeter at the top of the cap adjoined to a conformable section, said conformable section having an internal recess for engaging with a stopper and for sealing around a container opening, and said conformable section is further selected from the group consisting of elastomers, rubbers, thermoplastics wherein said cap allows vapor passage between the container and an external atmosphere;   a venting media formed of a polymer film and oriented at the top of the cap and external to said container opening forming a barrier isolating the container from the external atmosphere;   
     
     
         2 . The cap assembly of  claim 1 , wherein said cap is hermetically sealed to said container. 
     
     
         3 . The cap assembly of  claim 1 , wherein said cap comprises a single material. 
     
     
         4 . The cap assembly of  claim 1 , wherein said cap comprises at least two components. 
     
     
         5 . The cap assembly of  claim 4 , wherein said cap assembly comprises a rigid section and a conformable section. 
     
     
         6 . A cap assembly for the isolation of contents in a stoppered container comprising:
 a cap having a top and a bottom, said cap comprising a housing having a sealing perimeter at the top of the cap adjoined to a conformable section with an interior recess adapted for sealing around an exterior opening of a container, said conformable section is selected from the group consisting of elastomers, rubbers, thermoplastics wherein said cap allows vapor passage between the container and an external atmosphere; and   a venting media formed of a polymer film and oriented in said vapor path and external to said exterior opening of the container forming a barrier isolating the container from the external atmosphere,   wherein the cap and venting media are further removable from the closed container.   
     
     
         7 . The cap assembly of  claim 6 , wherein said cap is hermetically sealed to said container. 
     
     
         8 . The cap assembly of  claim 6 , wherein said cap comprises a single material. 
     
     
         9 . The cap assembly of  claim 6 , wherein said cap comprises at least two components. 
     
     
         10 . The cap assembly of  claim 9 , wherein said cap assembly comprises a rigid section and a conformable section. 
     
     
         11 . The cap assembly of  claim 6 , wherein said venting media comprises a hydrophobic material. 
     
     
         12 . The cap assembly of  claim 6 , wherein said venting media comprises expanded polytetrafluoroethylene. 
     
     
         13 . A cap assembly comprising for isolation of contents in a stoppered container, comprising:
 a multiple component body including a removable housing sealed to a conformable base having a recess for sealing to an internally housed container, said conformable base is further selected from the group consisting of elastomers, rubbers, thermoplastics said housing forms a vapor path for vapor passage between the container and an external atmosphere; and   a venting media formed of a polymer film and configured to contact with the conformable base of the body and oriented in said vapor path forming a barrier isolating the container from the external atmosphere, during drying processes.   
     
     
         14 . The cap assembly of  claim 13  further comprising a top covering. 
     
     
         15 . The cap assembly of  claim 14  wherein the top covering is sealed to the venting media. 
     
     
         16 . The cap assembly of  claim 14  further comprising a gasket between the top covering and the venting media. 
     
     
         17 . A removable sealing and barrier device compatible with stopper and vial assemblies comprising:
 a cap comprising a removable housing sealed to a conformable section having an internal recess for sealing around a container opening, said cap forms a vapor path for vapor passage between the container opening an external atmosphere; and said conformable section is further selected from the group consisting of elastomers, rubbers, thermoplastics; and   a venting media formed of a polymer film and configured to contact with the housing of the cap and oriented in said vapor path forming a barrier isolating the container from the external atmosphere.   
     
     
         18 . The cap assembly of  claim 6 , wherein said cap assembly is adapted for maintaining the stopper in a first position which allows passage of vapor between said container and the external atmosphere and moving said stopper to a second position to close the container and prevent the passage of vapor. 
     
     
         19 . A removable processing cap assembly for isolation of contents in a stoppered container, comprising:
 a cap having a top and a bottom, said cap comprising a housing with a sealing perimeter at the top of the cap adjoined to a conformable section, said conformable section having an internal recess for engaging with a stopper and for sealing around a container opening, said conformable section is further selected from the group consisting of elastomers, rubbers, thermoplastics wherein said cap allows vapor passage between the container and an external atmosphere;   a venting media formed of an expanded polytetraflouroethylene membrane and oriented at the top of the cap and external to said container opening forming a barrier isolating the container from the external atmosphere.   
     
     
         20 . A removable sealing and barrier device compatible with stopper and vial assemblies comprising:
 a cap comprising a removable housing sealed to a conformable section having an internal recess for sealing around a container opening, said cap forms a vapor path for vapor passage between the container opening an external atmosphere; and said conformable section is further selected from the group consisting of elastomers, rubbers, thermoplastics and   a venting media formed of an expanded polytetraflouroethylene membrane and configured to contact with the housing of the cap and oriented in said vapor path forming a barrier isolating the container from the external atmosphere.   
     
     
         21 . A cap assembly comprising for isolation of contents in a stoppered container, comprising:
 a multiple component body including a removable housing sealed to a conformable base having a recess for sealing to an internally housed container, said conformable section is further selected from the group consisting of elastomers, rubbers, thermoplastics said housing forms a vapor path for vapor passage between the container and an external atmosphere; and
 a venting media formed of an expanded polytetraflouroethylene membrane and configured to contact with the conformable base of the body and oriented in said vapor path forming a barrier isolating the container from the external atmosphere, during drying processes.