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Shanghai, China

Hong H.-Y.,Pall China Life Science | Tang Y.,Pall China Life Science | Xie T.,Pall China Life Science | Dong W.,Pall China Life Science | And 2 more authors.
Chinese Journal of New Drugs | Year: 2011

Determination of extractables and leachables for filters must be addressed as a part of process validation when sterilizing filtration technology is used. In this article, we reviewed the topics related to extractables/leachables validation including factors in related process, validation strategy and method, potential extractables/leachables species. We want to provide references for the filter users in pharmaceutical application.

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