PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Regular Article
A New Package System: A Multiple Chamber Plastic Bag Packaging Parenteral Powder Drug and Diluent
Fujio INOUEShigetoshi KASHIYAMAMasamitsu IZUMI
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1999 Volume 1 Issue 1 Pages 37-43

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Abstract

  A novel dual-chamber Bag (O-IN-Bag) was designed using a film which is a blend of polyethylene and polypropylene. The Bag is divided into by welding two chambers by an easy-to-peel seal (EPS). The upper chamber is filled with an injectable powder or lyophilized drug and the lower chamber is filled with 100 ml of diluent such as 0.9% sodium chloride. In the present report, we describe the characteristics of this O-IN-Bag product. The generation of particulate matter at the breakage of the EPS, stability of cefazolin sodium (CEZ), strength of the Bag container, and sterility of the inside of the container were studied. The results were compared with those of a conventional injectable system wherein antibiotics in glass vials are reconstituted with diluent using a double-ended transfer needle or a syringe. Reportedly, the O-IN-Bag system significantly reduces the time required to reconstitute drugs and storage space, and is easy to dispose. The system could retain the sterility and stability of its contents, and generated less particulate matter than the conventional system. In addition, the Bag proved physically strong enough as a container.

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© 1999 Parenteral Drug Association Japan Chapter
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