Risk assessment paradigm: An opportunity for rationalizing the choice of biological indicator during the validation of isolator biodecontamination cycles

PDA Journal of Pharmaceutical Science and Technology

Volumn 60, Issue 3, 2006, Pages 156-163

  Sansoë Bourget, Emmanuelle ^a  

^a Getinge La Calhene   (France)

Author keywords

Biological indicator; HACCP; Hydrogen peroxide; Isolator; Paracetic acid; Risk assessment

Indexed keywords

BIOLOGICAL MARKER; CHEMOSTERILANT; HYDROGEN PEROXIDE; PERACETIC ACID;

ARTICLE; BIOTECHNOLOGICAL PROCEDURES; CRITICAL CONTROL POINT; DRUG MIXTURE; ECONOMIC EVALUATION; HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEM; HAZARD ASSESSMENT; ISOLATION PROCEDURE; ISOLATOR BIODECONTAMINATION; RELIABILITY; REPRODUCIBILITY; RISK ASSESSMENT; WASTE MANAGEMENT;

BACILLUS STEAROTHERMOPHILUS; BACILLUS SUBTILIS; DECONTAMINATION; DISINFECTANTS; ENVIRONMENT, CONTROLLED; EQUIPMENT CONTAMINATION; GEOBACILLUS STEAROTHERMOPHILUS; GUIDELINES; GUIDELINES AS TOPIC; HYDROGEN PEROXIDE; INDICATORS AND REAGENTS; PERACETIC ACID; PROPORTIONAL HAZARDS MODELS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; STERILIZATION; TIME FACTORS;

EID: 33745665360     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. Chapter 5.1.2. Indicateurs Biologiques de Stérilisation. In European Pharmacopeia 5.0.; Direction de la Qualité du Médicament du Conseil de l'Europe: 67075 Starsbourg Cedex, France, 2005; pp 477-478.
2. Whyte, W.; Eaton, T. Assessing microbial risk to patients from aseptically manufactured pharmaceuticals. European Journal of Parenteral & Pharmaceutical Sciences 2004, 9 (3), 71-77.
3. Kokubo, M.; Inoue, T.; Akers, J. Resistance of common environmental spores of the genus Bacillus to vapor hydrogen peroxyde. PDA Journal of Pharmaceutical Science & Technology 1999, 52 (5), 228-231.
4. Tidswell, E. C. Bacterial adhesion: consideration within a risk-based approach to cleaning validation. PDA Journal of Pharmaceutical Science & Technology 2005, 59 (1), 10-32.
5. Chapter (1035) Biological Indicators for Sterilization. In United States Pharmacopeia 25; The United States Pharmacopeial Convention, Inc.: 12601 Twinbrook Parkway, Rokville, MD 20852, 2001; pp 2099-2101.
6. Whyte, W.; Eaton, T. Microbiological contamination models for use in risk assessment during pharmaceutical production. European Journal of Parenteral & Pharmaceutical Sciences 2004, 9 (1), 11-15.
7. Whyte, W.; Eaton, T. Microbial risk assessment in pharmaceutical cleanrooms. European Journal of Parenteral & Pharmaceutical Sciences 2004, 9 (1), 16-23.
8. Haberer, K. Manufacturing of BIs. European Compliance Academy-European GMP Education Course: Bioindicators-Current GMP Requirements on the Use of BIs. Vienna, February 2005.
9. Pflug I. J. Variability in the data generated by laboratories measuring D-values of bacterial spores. PDA Journal of Pharmaceutical Science & Technology 2005, 59 (1), 3-9.
10. Sigwarth, V.; Stärk, A. Effect of carrier materials on the resistance of spores of Bacillus stearothermophilus to gaseous hydrogen peroxyde. PDA Journal of Pharmaceutical Science & Technology 2003, 57(1), 3-11.
11. Cooper, M. S. Aseptic processing of sterile pharmaceuticals, biopharmaceuticals, and medical devices. Part I. The Microbiological Update 2005, 23 (4), #3#.
12. Food and Drug Administration (FDA). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (Appendix 1: Aseptic Processing Isolators); September 2004, 44-48.
13. Chapter (1208) Sterility Testing-Validation of Isolator Systems (in-process revision). Pharmacopeial Forum 2004, 30 (6), 2162-2167.