Microbiology laboratory methods in support of the sterility assurance system

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Volumn , Issue , 2003, Pages 120-143

  Bill, Andrew ^a  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 80053621223     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (10)

1. BS 5295 (1989) Environmental cleanliness in enclosed spaces. British Standards Institution, London.
2. Baird, R.M. (1999) Sterility assurance; concepts methods and problems. In: Russell, A.D., Hugo, W.B. and Ayliffe, G.A.J. (eds), Principles and Practice of Disinfection, Preservation and Sterilization, 3rd edn. Blackwell, Oxford, pp. 787-800.
3. Denyer, S.P. and Hodges, N.A. (1998) Sterilization control and sterility assurance. In: Hugo, W.B. and Russell, A.D. (eds), Pharmaceutical Microbiology, 6th edn. Blackwell, Oxford, pp. 439-52.
4. EN 550 (1994) Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization. British Standards Institution, London.
5. EN 552 (1994) Sterilization of medical devices - Validation and routine control of sterilization by irradiation. British Standards Institution, London.
6. EN 1174 (1996, 1997) Estimation of the population of micro-organisms on product. British Standards Institution, London.
7. EN 866 (1997) Biological systems for testing sterilizers and sterilization processes. British Standards Institution, London.
8. European Pharmacopoeia (1997) 3rd edn. EP Secretariat, Strasbourg.
9. Federal Standard 209E (1992) Cleanroom and workstation requirements, controlled environment. Washington, DC.
10. Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997) Part Four. Guide to Good Manufacturing Practice for Medicinal Products. The Stationery Office. ISBN 0-11-321995-4.