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.