Package making – Methods – Sterilizing complete package
Patent
1985-01-16
1986-05-13
Coan, James F.
Package making
Methods
Sterilizing complete package
53111R, 53428, 53434, B65B 5502
Patent
active
045877939
ABSTRACT:
A novel aseptic process for the preparation of intravenous and other pharmaceutical products, especially parenteral solution is provided as well as the pharmaceutical products produced thereby. The process involves ambient temperature mixing, filtering and filling in special enclosures, the surfaces of which have been rendered free of pathogenic organisms. The enclosures are further provided with sterile air by filtration through high efficiency particulate air filters. Positive pressure sterile air is caused to flow across the enclosure in a unidirectional, substantially lateral flow pattern in a generally diagonal direction, to effect a sweeping of sterile air in a continuous manner through the enclosure. Compounding of ingredients preferably is conducted in a separate enclosure from the filtration and filling processes. The apparatus is free of pathogenic organisms and includes a novel backflow pressure manifold system to control internal pressure exerted in the filtering and filling tubing. The novel products produced by the invention process can be stored for extended periods at refrigeration temperatures allowing infusion to be made available on a home care basis. New parenteral solutions are also provided which are compounded from the bulk powders of amino acids, dextrose, and electrolytes.
REFERENCES:
patent: 3035886 (1962-05-01), Hickey
patent: 3815315 (1974-06-01), Glick
patent: 4332122 (1982-06-01), Williams
patent: 4372100 (1983-02-01), Miller et al.
patent: 4522015 (1985-06-01), Hildebolt
Brennan Eric L.
Schawel Kenneth W.
Bethel George F.
Bethel Patience K.
Coan James F.
Home Health Care of America, Inc.
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