Title:
Guide to microbiological control in pharmaceuticals and medical devices
Author:
Denyer, S. P.
ISBN:
9781420021622
9780367800925
Edition:
2nd ed.
Publication Information:
Boca Raton, Fla. ; London : CRC Press, ©2007.
Physical Description:
1 online resource (482 pages) : illustrations
Contents:
Front cover; Preface to the Second Edition; Preface to the First Edition; The Editors; Contributors; Contents; Chapter 1. Introduction to Microbiology; Chapter 2. Microbial Contamination: Spoilage and Hazard; Chapter 3. Microbial Ecology of the Production Process; Chapter 4. The Design of Controlled Environments; Chapter 5A. Microbiological Considerations for Biotechnological Products; Chapter 5B. Microbiological Considerations in the Production of Medical Devices; Chapter 6. Good Manufacturing Practice in the Control of Contamination
Chapter 7. Dispersion of Airborne Conaminants and Conamination Risks in CleanroomsChapter 8. Monitoring Microbiological Quality: Conventional Testing Methods; Chapter 9. Monitoring Microbiological Quality: Application of Rapid Microbiological Methods to Pharmaceuticals; Chapter 10. Principles of Sterilization; Chapter 11. Sterilization Methods; Chapter 12. Assurance of Sterility by Process Validation; Chapter 13. Principles of Preservation; Chapter 14. Antimicrobial Preservatives and Their Properties; Chapter 15. Preservative Stability and Efficacy: Formulation Influences
Chapter 16. Package Integrity TestingChapter 17. Official Methods of Preservative Evaluation and Testing; Chapter 18. Preservative Evaluation and Testing: The Linear Regression Method; Chapter 19. Preservatives, Antimicrobial Agents, and Antioxidants: Registration and Regulatory Affairs*; Chapter 20. Microbial Standards for Pharmaceuticals; Chapter 21. Risk Management and Microbiological Auditing; Index; Back cover
Abstract:
Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license applica.
Electronic Access:
Taylor & Francis https://www.taylorfrancis.com/books/9780367800925OCLC metadata license agreement http://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf
Copies:
Available:*
Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 545546-1001 | RS199 .M53 G85 2007 EB | Searching... | Searching... |