References
- Use of aseptic processing and terminal sterilization in the preparation of sterile pharmaceuticals for human and veterinary use. Fed. Regist. 1991; 56(198)51354–51358, Code of Federal Regulations, Parts 211, 314, and 514, Title 21 1991
- Aseptic Fill Conference Transcripts. FDA Formal Meeting October 12–13, 1993; 1–1, through 1–85 and 11–1 through 11–38
- Guidance for Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Products. Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine. CVM, November, 1994
- Guideline for Submitting Documentation for Stability of Human Drugs and Biologics. CDER and CBER. 1978
- Moldenhauer J. D., Rubio S. L., Pflug I. J. Heat resistance of Bacillus Coagulens spores suspended in various parenteral solutions. PDA J. Pharm. Sci. Technol. 1995; 49(5)235–238