1. Sterility test failure investigations;Sandle;J. GXP Compliance,2012
2. A. Staerk, Media Fill bei mehrstufigen Prozessen, Wissenschaft und Technik, 2004.
3. Food, D. Administration, Guidance for industry: sterile drug products produced by aseptic processing, 2004.
4. Pharmaceutical Inspection Cooperation Scheme, Recommendation on the validation of aseptic processes, 2011.
5. The application of noninvasive headspace analysis to media fill inspection;Duncan;PDA J. Pharm. Sci. Technol./PDA,2016