著者

榎並 鈴子 齋藤 泉

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.4, no.2, pp.127-133, 2002 (Released:2006-07-18)

参考文献数

9

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For decreasing particulate matter in sterile products, it is important to find the cause of the particulate contamination by containers as well as drugs. Particulate matter in laminated aluminum film, which is one of the multiple materials to be useful for the container of drugs, was investigated by various methods. It was found that the number of particles in the water increased with time by the particle counter when water was filled in a bag of laminated aluminum film. The number of the generated particles from the bag left for several hours exceeded that of the bag shaken sixty times. Besides, many white particles were detected under the microscope by filtrating water. The white particles weren't observed from the polyethylene film alone before lamination. And white particles was observed irrespective of treatment of heat-seal. Therefore, it was supposed lamination process was the cause of the particle formation. The number of particles in heat-sealed bag increased about twice as many as the number of particles in non-heat-seal bag (sealed by adhesive tape). Therefore, the treatment of heat-seal was also cause of the particle formation. In either case, film was held under high temperature and high pressure. Moreover, analyses of white particles showed that main ingredient in particles was same with an ingredient in polyethylene film which was soluble in ethanol. Therefore, it was presumed that the condition of high temperature and pressure caused the particle formation from an impurity in polyethylene, and particles appeared in water.