Controlled non-classified filling device and method
First Claim
1. An apparatus comprising:
- a housing at least partially defining a processing space;
a support for releasably holding at least one device defining an interior sealed from ambient atmosphere and an elastic member in fluid communication with the interior and penetrable by a piercing or penetrating member or cannula;
a conveyor defining a path for transporting the support and the at least one device along the path and through the processing space; and
within the processing space;
a de-contamination station located on the conveyor path and configured to de-contaminate at least an exterior portion of the elastic member;
a dispensing station located on the conveyor path downstream of the de-contamination station and including at least one piercing or penetrating member or cannula coupled or connectible in fluid communication with a source of substance to be dispensed into the interior of the at least one device, wherein one or more of (i) the at least one piercing or penetrating member or cannula or (ii) the at least one device is movable relative to the other within the dispensing station to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispense substance through the at least one piercing or penetrating member or cannula and into the interior, and withdraw the at least one piercing or penetrating member or cannula from the elastic member;
a sealing station located on the conveyor path downstream of the dispensing station configured to hermetically seal the interior from ambient atmosphere; and
a cap storage configured for storing a cap removed from the at least one piercing or penetrating member or cannula during dispensing of substance into and sealing of the interior.
2 Assignments
0 Petitions
Accused Products
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.
78 Citations
32 Claims
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1. An apparatus comprising:
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a housing at least partially defining a processing space; a support for releasably holding at least one device defining an interior sealed from ambient atmosphere and an elastic member in fluid communication with the interior and penetrable by a piercing or penetrating member or cannula; a conveyor defining a path for transporting the support and the at least one device along the path and through the processing space; and within the processing space; a de-contamination station located on the conveyor path and configured to de-contaminate at least an exterior portion of the elastic member; a dispensing station located on the conveyor path downstream of the de-contamination station and including at least one piercing or penetrating member or cannula coupled or connectible in fluid communication with a source of substance to be dispensed into the interior of the at least one device, wherein one or more of (i) the at least one piercing or penetrating member or cannula or (ii) the at least one device is movable relative to the other within the dispensing station to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispense substance through the at least one piercing or penetrating member or cannula and into the interior, and withdraw the at least one piercing or penetrating member or cannula from the elastic member; a sealing station located on the conveyor path downstream of the dispensing station configured to hermetically seal the interior from ambient atmosphere; and a cap storage configured for storing a cap removed from the at least one piercing or penetrating member or cannula during dispensing of substance into and sealing of the interior. - View Dependent Claims (2, 10, 11)
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3. An apparatus comprising:
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a housing at least partially defining a processing space; a support for releasably holding at least one device defining an interior sealed from ambient atmosphere, and an elastic member in fluid communication with the interior and penetrable by a piercing or penetrating member or cannula; a conveyor defining a path for transporting the support and the at least one device along the path and through the processing space; and within the processing space; a de-contamination station located on the conveyor path and configured to de-contaminate at least an exterior portion of the elastic member; a dispensing station located on the conveyor path downstream of the de-contamination station and including at least one piercing or penetrating member or cannula coupled or connectible in fluid communication with a source of substance to be dispensed into the interior of the device, wherein one or more of (i) the at least one piercing or penetrating member or cannula or (ii) the device is movable relative to the other within the dispensing station to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispense substance through the at least one piercing or penetrating member or cannula and into the interior, and withdraw the at least one piercing or penetrating member or cannula from the elastic member; a sealing station located on the conveyor path downstream of the dispensing station configured to hermetically seal the interior from ambient atmosphere; and a source of substance placeable into and removable from fluid communication with the dispensing station by a sterile or aseptic connector comprising a first connector portion and a second connector portion that are movable between a disconnected position wherein the first and second connector portions are not connected to each other and a connected position wherein the first and second connector portions are connected to each other, and that is configured to provide, in the connected position, a fluid flow path between the source of substance and the dispensing station that is sealed from the ambient atmosphere and the source of substance is placed into fluid communication with the dispensing station, and, in the disconnected position, maintains the fluid flow path sealed from the ambient atmosphere and the source of substance is not in fluid communication with the dispensing station. - View Dependent Claims (4, 5, 6, 7, 20, 21, 22, 23, 28, 29, 30, 31, 32)
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8. A method comprising the following steps:
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(i) installing at least one piercing or penetrating member or cannula into a dispensing device and in fluid communication with a source of substance, wherein the at least one piercing or penetrating member or cannula is housed within a cap and the dispensing device comprises; a housing at least partially defining a processing space; a support for releasably holding at least one device defining an interior sealed from ambient atmosphere, and an elastic member in fluid communication with the interior and penetrable by a piercing or penetrating member or cannula; a conveyor defining a path for transporting the support and the at least one device along the path and through the processing space; and within the processing space; a de-contamination station located on the conveyor path and configured to de-contaminate at least said elastic member; a dispensing station located on the conveyor path downstream of the de-contamination station and including the at least one piercing or penetrating member or cannula, wherein one or more of (a) the at least one piercing or penetrating member or cannula or (b) the at least one device is movable relative to the other within the dispensing station to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispense substance through the at least one piercing or penetrating member or cannula and into the interior, and withdraw the at least one piercing or penetrating member or cannula from the elastic member; and a sealing station located on the conveyor path downstream of the filling station configured to hermetically seal the interior from ambient atmosphere; (ii) removing the cap from the at least one piercing or penetrating member or cannula; (iii) storing the cap in the dispensing device at a storage location; (iv) de-contaminating at least an exterior portion of an elastic member of a device defining an interior sealed from ambient atmosphere in fluid communication with the elastic member; (v) moving one or more of (a) the at least one piercing or penetrating member or cannula or (b) the device relative to the other to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispensing substance through the at least one piercing or penetrating member or cannula and into the interior, and withdrawing the at least one piercing or penetrating member or cannula from the elastic member; and (vi) sealing the interior from ambient atmosphere. - View Dependent Claims (9, 12, 13, 14, 15, 16, 17, 18, 19, 24, 25, 26, 27)
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Specification