US 4,730,435 AGranted

Sterile docking system for filling IV bags

AssigneeAqua-Chem, Inc.

InventorsRichard A. Riddle, Natale J. Cerami, Deborah L. Jackman

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Abstract

An apparatus for aseptically filling and sealing preformed bags includes a carousel table supporting a number of bags along its periphery, each bag having a nozzle initially sealed by a diaphragm. As the carousel table brings an individual bag under a sterile docking unit, that unit lowers over the bag and showers the nozzle and diaphragm with HEPA filtered air to remove particulate matter and bioburden. A flash heat sterilizer sterilizes the diaphragm and the top of the nozzle and at least partially melts the diaphragm. A heat sterilized fill pipe descends, piercing the diaphragm and filling the bag. When filling is completed, the fill pipe partially withdraws, the lower portion of the pipe remaining inserted in the nozzle. A heat sealer then seals the nozzle below the tip of the pipe. The pipe completely withdraws, the sterile docking unit moves clear of the bag, and the carousel table rotates, thus moving an empty bag into position for filling.

Claims17

Dependent claims

An apparatus for aseptically filling and sealing preformed flexible bags, said apparatus comprising:

(a) a frame, including a central shaft;
(b) a carousel table rotatably mounted to said shaft, said carousel table designed to hold a plurality of bags around the periphery of said table, each of said bags comprising an elongate nozzle and a circular diaphragm sealing the top thereof;
(c) means for positioning an individual bag in an operational position;
and
(d) a sterile docking unit located above said carousel table, said sterile docking unit comprising:
(1) an open-bottom housing positioned above said carousel table;
(2) means for generating a downward laminar air flow through said housing;
(3) filler means within said housing;
(4) sterilizing means within said housing designed to sterilize the diaphragm and upper portion of the nozzle of a bag in said operational position, wherein said sterilizing means comprises:
a sterilizing element movable between a first position wherein said sterilizing element is clear of the travel path of said filler means and the nozzle of a bag in said operational position, and a second position wherein said sterilizing element and said diaphragm are in concentric contact;
means connected to said sterilizing means for heating said sterilizing element to a temperature sufficient to sterilize said diaphragm and the upper portion of the nozzle and to at least partially melt said diaphragm;
and
means to move said sterilizing element between said first and second positions;
and
(5) sealing means, located beneath and adjacent to said housing adapted to seal the nozzle of a bag in the operational position.

12 more elements

An apparatus for aseptically filling and sealing preformed containers, said apparatus comprising:

(a) means for conveying a number of preformed containers, said conveying means periodically moving an individual container into an operational position, each of said individual containers having an elongate nozzle sealed by a circular diaphragm;
and
(b) a sterile docking unit above and conveying means, said sterile docking unit comprising:
(1) an open-bottomed housing positioned above said conveying means;
(2) means for generating a downward laminar air flow through said housing;
(3) filler means within said housing;
(4) sterilizing means within said housing designed to sterilize the diaphragm and upper portion of the nozzle of a container in said operational position, wherein said sterilizing means comprises:
a sterilizing element movable between a first position, wherein said sterilizing element is clear of the travel path of said filler pipe and the nozzle of a bag in said operational position, and a second position, wherein said sterilizing element and said diaphragm are in concentric contact;
means connected to said sterilizing means for heating said sterilizing element to a temperature sufficient to sterilize said diaphragm and the upper portion of the nozzle and to at least partially melt said diaphragm;
and
means to move said sterilizing element between said first and second positions;
and
(5) sealing means, beneath said housing designed to seal a container in said operational position.

10 more elements

Dependencies are inferred from the claim text.