Controlled non-classified filling device and method

Abstract

An injection member penetrates an elastic septum of a device defining a sealed, empty, sterile chamber in fluid communication with the septum. During penetrating, an annular interface is formed between the septum and the injection member extending axially between a penetration point on an interior surface of the septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member. The injection member is de-contaminated by (i) friction between the septum and injection member at the annular interface, and (ii) elongation of the septum at the annular interface. A substance is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.

What is claimed is: 
     
         1 . An apparatus comprising:
 a formulation container including a formulation chamber that is sealed with respect to ambient atmosphere;   at least one inlet port in fluid communication with the formulation chamber;   at least one outlet port in fluid communication with the formulation chamber;   a plurality of substance supply containers, each containing substance therein;   a plurality of sterile or aseptic connectors sealingly connected in fluid communication with the at least one inlet port, wherein each of the plurality of connectors is normally closed and defines a flow conduit therein that is sterile and sealed with respect to ambient atmosphere for preventing exposure of any substance flowing therein to the ambient atmosphere and is configured to place the at least one inlet port in fluid communication with a respective substance from a respective supply container, wherein the plurality of connectors seal the at least one inlet port with respect to ambient atmosphere;   and at least one outlet sterile or aseptic connector sealingly connected in fluid communication with the at least one outlet port, wherein each outlet connector is normally closed and defines a flow conduit therein that is sterile or aseptic and sealed with respect to ambient atmosphere for preventing exposure of any substance flowing therein to the ambient atmosphere, wherein the at least one outlet connector seals the at least one outlet port with respect to ambient atmosphere, and is configured to place the at least one outlet port in aseptic or sterile fluid communication with a dispensing device.   
     
     
         2 . An apparatus as defined in  claim 1 , wherein each of the plurality of connectors and each outlet connector comprises a male connector portion including a piercing or penetrating member or cannula, and a female connector portion including an elastic member, and the male connector and female connector are engageable with each other to define a fluid flow path through the respective connector or outlet connector. 
     
     
         3 . An apparatus as defined in  claim 1 , further comprising a plurality of flexible fluid lines, wherein each flexible fluid line is sealingly connected in fluid communication between the at least one inlet port and one of the connectors or the at least one outlet port and at least one of the at least one outlet connector, and an exterior of each respective flexible fluid line is engageable with a respective peristaltic pump for pumping fluid through the respective fluid line with the respective peristaltic pump. 
     
     
         4 . An apparatus as defined in  claim 1 , further comprising a dispensing device that is sealed from the ambient atmosphere, in fluid communication with at least one of the at least one outlet connector, and configured to receive multiple doses of formulation therefrom while maintaining said doses of formulation sealed with respect to ambient atmosphere. 
     
     
         5 . A method comprising: aseptically or sterile transferring a plurality of sterile or aseptic substances from respective substance supply containers to a formulation container, and combining the plurality of substances within the formulation container into a sterile or aseptic formulation, wherein each substance is sealed with respect to ambient atmosphere in its respective substance supply container, the transferring is performed without exposure of the substances to the ambient atmosphere, and the substances are sealed with respect to ambient atmosphere in the formulation container. 
     
     
         6 . A method as defined in  claim 5 , further comprising aseptically or sterile transferring the formulation from the formulation container to a dispensing device without exposure of the formulation to the ambient atmosphere, wherein the formulation is sealed with respect to ambient atmosphere in the dispensing device. 
     
     
         7 . A method as defined in  claim 6 , further comprising dispensing multiple doses of the formulation from the dispensing device while maintaining the formulation remaining within the dispensing device sterile or aseptic and hermetically sealed with respect to the ambient atmosphere. 
     
     
         8 . A method as defined in  claim 7 , wherein one or more of (i) the transferring of substances to the formulation container or (ii) the transferring of formulation to the dispensing device is performed without exposure of the respective substances or formulation to germs or other contaminants. 
     
     
         9 . A method as defined in  claim 6 , wherein the transferring of substances from the respective substance supply containers to the formulation container includes moving one or more of (i) a piercing or penetrating member or cannula or (ii) an elastic member relative to the other between a first position where the piercing or penetrating member or cannula is not penetrating the elastic member and a second position where the piercing or penetrating member or cannula is penetrating or passing through the elastic member, decontaminating the piercing or penetrating member or cannula by one or more of (i) imparting sufficient friction force between the elastic member and respective piercing or penetrating member or cannula at the annular interface, or (ii) sufficient elongation of the elastic member at the annular interface during movement between the first position and the second position, and introducing the plurality of substances or formulation through the piercing or penetrating member or cannula in the second position. 
     
     
         10 . A method as defined in  claim 6 , further comprising (i) connecting a respective sterile or aseptic connector in fluid communication between each respective substance supply container and the formulation container, wherein the transferring to the formulation container includes one or more of transferring a respective substance through the respective connector, or (ii) connecting an outlet sterile or aseptic connector in fluid communication between the formulation container and the dispensing device, wherein the transferring to the dispensing device includes transferring the formulation from the formulation container through the outlet connector. 
     
     
         11 . A method for transfer of substance, comprising:
 (a) engaging a first device with a second device, wherein the first device defines an interior that is hermetically sealed with respect to ambient atmosphere and a piercing or penetrating member or cannula including at least one port in fluid communication with the interior for flowing substance therethrough, and the second device defines an interior hermetically sealed with respect to ambient atmosphere and an elastic member defining an interior surface in fluid communication with the interior of the second device and an exterior surface;   (b) during the engaging step, penetrating or passing through the elastic member with the piercing or penetrating member or cannula from the exterior surface to the interior surface so that the at least one port is in fluid communication with the interior of the second device, and during the penetrating or passing through step, forming an annular interface between the elastic member and the piercing or penetrating member or cannula extending axially between a point of contact on the interior surface and the exterior surface of the elastic member engaging the piercing or penetrating member or cannula, and de-contaminating the piercing or penetrating member or cannula by (i) imparting sufficient friction force between the elastic member and the piercing or penetrating member or cannula at the annular interface, and/or (ii) sufficient elongation of the elastic member at the annular interface during the penetrating or passing through step;   (c) flowing substance between the interior of the first device and the interior of the second device through the at least one port; and   (d) maintaining the interior of the first device and the interior of the second device sealed from ambient atmosphere during steps (a) through (c).   
     
     
         12 . A method as defined in  claim 11 , wherein the elastic member defines a penetration zone that is penetrated or passed through by the piercing or penetrating member or cannula during the penetrating or passing through step, and the penetration zone is shaped to enhance the pressure exerted by the elastic member onto the piercing or penetrating member or cannula during the penetrating or passing through step. 
     
     
         13 . A method as defined in  claim 11 , further comprising reducing strain on the interior surface of the elastic member within a zone of penetration of the piercing or penetrating member or cannula during the penetrating or passing through step with a groove formed on the interior surface of the elastic member and extending substantially about the zone of penetration. 
     
     
         14 . A method as defined in  claim 11 , wherein the de-contaminating of the piercing or penetrating member or cannula includes exerting pressure with the elastic member onto the piercing or penetrating member or cannula at the annular interface between the elastic member and the piercing or penetrating member or cannula and, in turn, killing organisms at the interface. 
     
     
         15 . A method as defined in  claim 11 , wherein the first device and the second device define a sterile or aseptic connector. 
     
     
         16 . An apparatus for transfer of substance, comprising:
 a first device defining an interior that is hermetically sealed with respect to ambient atmosphere and a piercing or penetrating member or cannula including at least one port in fluid communication with the interior for flowing substance therethrough; and   a second device defining an interior hermetically sealed with respect to ambient atmosphere and an elastic member defining an interior surface in fluid communication with the interior of the second device and an exterior surface;   wherein the first device and second device are moveable relative to each other between a disengaged position and an engaged position, and upon movement of the first device and second device from the disengaged position to the engaged position the piercing or penetrating member or cannula penetrates or passes through the elastic member from the exterior surface to the interior surface, an annular interface is formed between the elastic member and the piercing or penetrating member or cannula extending axially between a point of contact on the interior surface of and the exterior surface of the elastic member engaging the piercing or penetrating member or cannula, the piercing or penetrating member or cannula is de-contaminated by (i) imparting sufficient friction force between the elastic member and the piercing or penetrating member or cannula at the annular interface, and/or (ii) sufficient elongation of the elastic member at the annular interface, the at least one port is in fluid communication with the interior of the second device to permit flow through the at least one port, and the interior of the first device and the interior of the second device are maintained sealed from ambient atmosphere.   
     
     
         17 . An apparatus as defined in  claim 16 , wherein the elastic member defines a penetration zone that is penetrable or passable through by the piercing or penetrating member or cannula, and the penetration zone is shaped to enhance pressure exerted by the elastic member onto the piercing or penetrating member or cannula during penetration or passing through thereof by the piercing or penetrating member or cannula. 
     
     
         18 . An apparatus as defined in  claim 16 , further comprising means for reducing strain on an interior surface of the elastic member during penetration or passing through thereof by the piercing or penetrating member or cannula. 
     
     
         19 . An apparatus as defined in  claim 16 , wherein the elastic member is configured to exert pressure onto the piercing or penetrating member or cannula at the annular interface between the elastic member and piercing or penetrating member or cannula to thereby kill organisms at the interface. 
     
     
         20 . An apparatus as defined in  claim 16 , wherein the first device and the second device define a sterile or aseptic connector.