Microbial limit and bioburden tests: validation approaches and global requirements/
Lucia Clontz.
- 2nd ed.
- 2008. CRC Press, London:
- xv, 325 p. : ill. ; 25 cm.
Ch. 1. Microbial Life and Ecology Ch. 2. Microbial Contamination and Control Ch. 3. The USP Microbial Limit Tests Ch. 4. Pharmaceutical Waters Ch. 5. Environmental Monitoring Ch. 6. Bioburden Considerations in Equipment-Cleaning Validation Ch. 7. Method Validation and Media Suitability Testing Ch. 8. Microbiological Quality of Pharmaceutical and Biopharmaceutical Products and Raw Materials Ch. 9. Rapid Testing and Alternative Methods in Microbiology Ch. 10. Biofilms Ch. 11. Handling Aberrant and Out-of-Specification Microbial Data