Rosamund Baird / Stephen P. Denyer (eds.)

Guide to Microbiological Control in Pharmaceuticals and Medical Devices

Herausgeber: Baird, Rosamund M.; Denyer, Stephen P.

• Gebundenes Buch

Produktbeschreibung

This new edition covers those principal aspects of microbiology that are relevant to the preformulation, formulation, manufacturing and licence application stages involved with the production of pharmaceuticals, while expanding the book's focus to include medical devices. This work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores 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.

Produktdetails

• Verlag: Taylor & Francis Ltd
• 2 ed
• Seitenzahl: 498
• Erscheinungstermin: 26. Dezember 2006
• Englisch
• Abmessung: 238mm x 161mm x 35mm
• Gewicht: 834g
• ISBN-13: 9780748406159
• ISBN-10: 0748406158
• Artikelnr.: 22260230

Autorenporträt

Stephen P. Denyer, Rosamund M. Baird

Inhaltsangabe

Introduction to microbiology. Microbial contamination: spoilage and hazard.
Microbial ecology of the production process. The design of controlled
environments. Microbiological considerations for biotechnological products.
Microbiological considerations in the production of medical devices. Good
manufacturing practice in the control of contamination. Dispersion of
airborne contaminants and contamination risks in clean rooms. Monitoring
microbiological quality: conventional testing methods. Monitoring
microbiological quality: application of rapid microbiological methods to
pharmaceuticals. Principles of sterilization. Sterilization methods.
Assurance of sterility by process validation. Principles of preservation.
Antimicrobial preservatives and their properties.
Preservative stability and efficacy: formulation influences. Package
integrity testing. Official methods of preservative evaluation and testing.
Preservative evaluation and testing : the linear regression method.
Preservatives, antimicrobial agents and antioxidants: registration and
regulatory affairs. Microbial standards for pharmaceuticals. Risk
management and microbiological auditing.