1. Are growth rates of Escherichia coli in batch cultures limited by respiration?;Andersen;Journal of Bacteriology,1980
2. Microbial limit and bioburden tests: Validation approaches and global requirements;Clontz,2013
3. CPMP. The European Agency for the Evaluation of Medicinal Products Committee for Proprietary Medicinal Products (CPMP). Note for guidance on manufacturing of the finished dosage form, CPMP/QWP/486/95.
4. FDA. Guidance for industry sterile drug products produced by aseptic processing—current good manufacturing practice. Bethesda, MD: FDA.
5. Validation of process chromatograph;Grund,2007