Updated to reflect the technological and regulatory changes that have come into play since publication of the first edition, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers those principal aspects of microbiology that are relevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals, while expanding the book's focus to include medical devices.

Features:

• Surveys both traditional and rapid techniques for monitoring microbiological quality
• Focuses on practical issues in product development and regulatory requirements
• Offers guidance on risk assessment
• Discusses sampling techniques and antimicrobial preservation

Covering good manufacturing practice in the control of contamination, Guide to Microbiological Control in Pharmaceuticals and Medical Devices also addresses monitoring microbiological quality, the preservation of pharmaceutical formulations and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity testing, and the evaluation of contamination risks in clean rooms.

Contents

1. Introduction to microbiology
2. Microbial contamination: spoilage and hazard
3. Microbial ecology of the production process
4. The design of controlled environments
5. Microbiological considerations for biotechnological products
6. Microbiological considerations in the production of medical devices
7. Good manufacturing practice in the control of contamination
8. Dispersion of airborne contaminants and contamination risks in clean rooms
9. Monitoring microbiological quality: conventional testing methods
10. Monitoring microbiological quality: application of rapid microbiological methods to pharmaceuticals
11. Principles of sterilization
12. Sterilization methods
13. Assurance of sterility by process validation
14. Principles of preservation
15. Antimicrobial preservatives and their properties
16. Preservative stability and efficacy: formulation influences
17. Package integrity testing
18. Official methods of preservative evaluation and testing
19. Preservative evaluation and testing: the linear regression method
20. Preservatives, antimicrobial agents and antioxidants: registration and regulatory affairs
21. Microbial standards for pharmaceuticals
22. Risk management and microbiological auditing

Index

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