TY  - BOOK
AU  - Clontz, Lucia
TI  - Microbial limit and bioburden tests: validation approaches and global requirements
SN  - 1420053485
U1  - 615.19 
PY  - 0000///London
CY  - 2008.
PB  - CRC Press
KW  - Drugs
KW  - Microbiology
KW  - Standard
KW  - Microbial Contamination
KW  - Measurement
N1  - 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
ER  -