Bag filling method and apparatus for preparing pharmaceutical sterile solutions
OwnerJames A. Benninventor
Life of this patent
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Abstract
A bag filling method and apparatus for preparing pharmaceutical steril solutions in a plurality of sterile flexible bags in a non-sterile environment, which method and apparatus comprise providing a pre-sterilized tubular bag having a single inlet, introducing a solution through a sterilizing filter and introducing the sterile solution into the inlet of the tubular bag and sealing defined sections of the tubular bag after filling to a defined volume of the sterile solution to form a plurality of separate, flexible, sterile bags thereby providing a rapid, inexpensive, automated method and apparatus to prepare sterile solutions in bags.
Claims21
A method of packaging a sterile solution into a plurality of sterile, flexible bags of defined volume in a non-sterile atmosphere, which method comprises:
- (a) providing a pre-sterilized bag set composed of a heat-sealable thermoplastic polymer, the bag set comprising a plurality of preformed, unfilled, individual bags of defined volume arranged in a sequentially connected series and adapted to be compactly stored in a unfilled condition, the bag set having a single inlet for the introduction of a sterile solution to be packaged and a single fill tube connected to the single inlet, the inlet tube extending generally the length of the bag set and a plurality of short, individual bag fill tubes extending from the single fill tube to be each of the individual bags of the bag set;
- (b) compactly storing the bag set in a storage means;
- (c) sequentially withdrawing from the compactly stored bag set, the individual bags;
- (d) introducing a sterile solution of a defined volume into the single inlet of the bag set and through the fill tube sequentially into the individual fill tubes of the individual bags as withdrawn from the storage means;
- (e) filling a defined volume of the sterile solution from the fill tube and through the individual fill tube into the withdrawn individual bag as withdrawn from the storage means;
- (f) sequentially heat sealing the individual bag fill tube after the filling of the sterile solution;
- and
- (g) removing from the bag set the individual, filled, sterile, heat-sealed, flexible bags.
A pre-sterilized bag set for use in a method of filling individual bags of the bag set with a defined volume of sterile solution, the pre-sterilized bag set composed of a heat sealable thermoplastic polymer, the bag set comprising a plurality of sequential, aligned, preformed, unfilled, separated, individual bags of defined volume, the bag set having a single inlet at the one end of the bag set for the introduction of a sterile solution to be packaged and a single fill tube connected to the inlet, the single fill tube extending along generally the entire length of the bag set, and a plurality of short, individual bag fill tubes extending from the single fill tube into each of the individual bags of the bag set.
Dependencies are inferred from the claim text.