Clontz, Lucia

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

1420053485


Drugs--Microbiology--Standard
Microbial Contamination--Measurement--Standard

615.19 / CLO/M