Design and Operational Qualification of a Vapor-Phase Hydrogen Peroxide Biological Indicator Evaluator Resistometer (BIER) Unit

Pharmaceutical Technology

Volumn 27, Issue 11, 2003, Pages 84-90

  Khorzad, Davoud ^a   Khorzad, Ashkan ^a   Herche, Jason ^a   Reich, Robert ^a   Caputo, Ross ^a  

^a PSI   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HYDROGEN PEROXIDE;

BIOOLGICAL INDICATORS;

DRUG PRODUCTS;

BIOLOGICAL MARKER; HYDROGEN PEROXIDE;

ANALYTIC METHOD; BIOLOGICAL INDICATOR EVALUATOR RESISTOMETER; CONCENTRATION RESPONSE; CONTAMINATION; FLOW RATE; GENERATOR; HUMIDITY; INSTRUMENT STERILIZATION; INSTRUMENTATION; ISOLATION PROCEDURE; REVIEW; STANDARD; TECHNICAL AID; TEMPERATURE MEASUREMENT; VAPORIZATION; WATER VAPOR;

EID: 0242610443     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (15)

1. R. Friedman, "Design of Barrier Isolators for Aseptic Processing: A GMP Perspective," Pharm. Eng. 18 (2), 28-33 (1998).
2. J.C. Lyda, "Regulatory Aspects of Isolation/Barrier Technology," PDA J. Pharm. Sci. Technol. 49 (6), 300-304 (1995).
3. C.M. Wagner and J. Raynor, "Industry Survey on Sterility Testing Isolators: Current Status and Trends," Pharm. Eng. 21 (2), 134-140 (2001).
4. J. Lysfjord and M. Porter, "Barrier Isolation History and Trends, A Millennium Update," Pharm. Eng. 21 (2), 142-145 (2001).
5. R. Caputo, "Comparative Resistance of Vaporized Hydrogen Peroxide Biological Indicators from Various Vendors," paper presented at the International Society for Pharmaceutical Engineering Conference-Barrier Technology Forum, Zurich, Switzerland, September 2002.
6. V. Sigwarth and A. Stark, "Effect of Carrier Materials on the Resistance of Spores of Bacillus stearothermophilus to Gaseous Hydrogen Peroxide," PDA J. Pharm. Sci. Technol. 57 (1), 3-11 (2003).
7. ISO 11138-1, "Sterilization of Health Care Products-Biological Indicators, Part 1: General Requirements," pp. 2-15 (October 1994).
8. EN 866-1, "Biological Systems for Testing Sterilizers and Sterilization Processes. Part 1: General Requirements," pp. 6-15 (September 1996).
9. Association for the Advancement of Medical Instruments (AAMI), "Steam Sterilization and Sterility Assurance in Health Care Facilities," ANSI/AAMI ST46:2002, Sec 7.4.3.2.
10. USP26-NF21, "Official Monograph: Biological Indicator of Steam Sterilization, Paper Carrier" (United States Pharmacopoeia, April 2003), pp. 247-248.
11. Association for the Advancement of Medical Instruments (AAMI), "Resistometers Used for Characterizing the Performance of Biological and Chemical Indicators," ANSI/AAMI ST44:2002, pp. 4, 8-11.
12. Association for the Advancement of Medical Instruments (AAMI), "Resistometers Used for Characterizing the Performance of Biological and Chemical Indicators," ANSI/AAMI ST44:2002, pp. 4-5, 12-16.
13. R. Caputo, "Comparative Resistance of Vaporized Hydrogen Peroxide Biological Indicators," paper presented at the ISPE Conference-11th Annual Barrier Technology Forum, Arlington, Virginia, June 2002.
14. Bioquell Pharma, "Clarus 'C' User Manual," STD20000-005, Rev. 4, Andover Hampshire, United Kingdom, 2002.
15. STERIS Corporation, "Operator Manual VHP 1000ED Biodecontamination System," Erie, Pennsylvania, 2002.