Microbial limit and bioburden tests: validation approaches and global requirements/ Lucia Clontz.
Material type: TextPublication details: 2008. CRC Press, LondonEdition: 2nd edDescription: xv, 325 p. : ill. ; 25 cmISBN: 1420053485Subject(s): Drugs -- Microbiology -- Standard | Microbial Contamination -- Measurement -- StandardDDC classification: 615.19Item type | Current library | Call number | Status | Notes | Date due | Barcode | Item holds |
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General Books Science Library | Science Library, Sikkim University Science Library General Section | 615.19 CLO/M (Browse shelf(Opens below)) | Available | Books For SU Science Library | P16393 |
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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
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