Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition
In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c
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Chapter 2 Microbial Contamination and Control
Chapter 3 The USP Microbial Limit Tests
Chapter 4 Pharmaceutical Waters
Chapter 5 Environmental Monitoring
Chapter 6 Bioburden Considerations in EquipmentCleaning Validation
Chapter 7 Method Validation and Media Suitability Testing
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Microbial Limit and Bioburden Tests: Validation Approaches and Global ...
Limited preview - 1997
1-mL aliquots 1:10 sample dilution agar plate antimicrobial aseptic Aspergillus Bacillus bacteria bile-tolerant Gram-negative bacteria Bioburden Tests biofilm Biofilm Reactor buffer solution Candida albicans Catalase chemical Cleanroom Clostridia coliform colonies containing coupons detection diluent dilution factor Drug Endotoxin enrichment broth enumeration Environmental Escherichia coli evaluation FIguRE fungi g or mL genuS gram Gram-negative incubation period Inoculate inoculum Isolate lactose MacConkey agar Manufacturing MEEB membrane filter membrane filtration membrane filtration method microbial microbial growth microbial identification microbial limit testing microbial recovery microbiological microorganisms milliliter of product mL of product molds neutralizers nonsterile pathogens Peptone Peptone Control Group performed pharmaceutical pour-plate product dilution Pseudomonas aeruginosa rinse Salmonella Salmonella spp sample preparation SCD agar specified spore Staphylococcus aureus sterile subculture suitability testing surface swab TABLE TAMC and TYMC Test for absence Test Group test organisms tube TYMC test USP Chapter validation yeast