著者

井上 冨士夫 樫山 薫明 泉 雅満

出版者

一般社団法人日本PDA製薬学会

雑誌

日本PDA学術誌 GMPとバリデーション (ISSN:13444891)

巻号頁・発行日

vol.1, no.1, pp.37-43, 1999 (Released:2006-08-04)

参考文献数

13

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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.