Guide to microbiological control in pharmaceuticals and medical devices/
edited by Stephen P Denyer and R M Baird
- 2nd ed.
- Boca Raton: CRC Press, 2007.
- 482 p.
Introduction to microbiology / Rosamund M. Baird and Stephen P. Denyer -- Microbial contamination: spoilage and hazard / Sally F. Bloomfield -- Microbial ecology of the production process / David N. Payne -- The design of controlled environments / Allan G. Cosslett -- Microbiological considerations for biotechnological products / Adekunle O. Onadipe -- Microbiological considerations in the production of medical devices / Haroon A.R.D. Atchia -- Good manufacturing practice in the control of contamination / Paul Hargreaves -- Dispersion of airborne contaminants and contamination risks in cleanrooms / Bengt Ljungqvist and Berit Reinmüller -- Monitoring microbiological quality: conventional testing methods / Rosamund M. Baird -- Monitoring microbiological quality: application of rapid microbiological methods to pharmaceuticals / Stephen P. Denyer -- Principles of sterilization / EAmonn V. Hoxey, nicolette Thomas, and David J.G. Davies -- Sterilization methods / Eric L. Dewhurst and Eamonn V. Hoxey -- Assurance of sterility by process validation / Klaus Haberer -- Principles of preservation / Donald S. Orth -- Antimicrobial preservatives and their properties / Stephen P. Denyer -- Preservative stability and efficacy: formulation influences / Hans van Doorne -- Package integrity testing / Lee E. Kirsch -- Official methods of preservative evaluation and testing / Michael J. Akers and Veda K. Walcott -- Preservative evaluation and testing: the linear regression method / Donald S. Orth -- Preservatives, antimicrobial agents, and antioxidants: registration and regulatory affairs / R. Keith Greenwood and Robin J. Harman -- Microbial standards for pharmaceuticals / Marie L. Rabouhans -- Risk management and microbiological auditing / Robert A. Pietrowski.