Features:

• Discusses measurement and control of contamination for safe drug manufacturing
• Offers logical approaches to problems associated with oral and nasal preparations
• Reviews the most common commercial rapid microbiological test methods
• Features a chapter on clean room finishes and construction materials - information available nowhere else
• Highlights microbial focus of clean room control and the importance of knowledgeable laboratory practices

Taking a multidisciplinary approach, Microbiological Contamination Control for Pharmaceutical Clean Rooms neatly clarifies some of the perceived problems surrounding contamination control in pharmaceutical industry clean rooms.

The book helps you satisfy domestic and international regulations and prevent your organization from suffering the consequences of non-compliance. It includes up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control. This valuable guide brings you up to date on the types of techniques available, the scientific principles that underpin them, and the practicalities and limitations of each.

Contents

1. Effects and Causes of Contamination in Sterile Manufacturing
2. Microbiological Environmental Monitoring
3. Media Fills and Their Applications
4. Contamination of Aqueous-Based Nonsterile Pharmaceuticals
5. Bioburden Determinations
6. Materials of Construction and Finishes for Safe Pharmaceutical Manufacturing
7. Rapid Microbiological Methods Explained

Glossary
Appendix
Index

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