Comparing and contrasting: Barrier isolator decontamination systems

Pharmaceutical Technology

Volumn 28, Issue 11, 2004, Pages 68-82

  Fisher, Jim ^b   Caputo, Ross A ^a  

^a Pharmaceutical Systems   (United States)

^b PSI ^*

Author keywords

[No Author keywords available]

Indexed keywords

DECONTAMINATION; HYDROGEN PEROXIDE;

BARRIER ISOLATORS; VAPOR PHASE;

DRUG PRODUCTS;

HYDROGEN PEROXIDE;

ARTICLE; COMMERCIAL PHENOMENA; EXAMINATION; HAND; VALIDATION PROCESS; VAPOR;

EID: 9644266661     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

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 Isolator/Barrier Technology," PDA Pharm. Sci. Tech., 49 (6), 200-304 (1995).
3. C.M. Wagner and J. Raynor, "Industry Survey on Sterility Testing Isolators: Current Status and Trends," Pharm. Eng. 21 (2), 124-140 (2001).
4. J. Lysfjord and M. Porter, "Barrier Isolation History and Trends, A Millennium Update," Pharm. Eng. 21 (2), 142-145 (2001).
5. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (FDA, Rockvilk, MD, 2001).
6. "Hydrogen Peroxide Vapour Biological Efficacy," V2.5 (BioQuell Pharma, Andover Hampshire, United Kingdom, February 2003).
7. "La Calhène Three Glove Transfer Isolator User's Manual," (La Calhène, Vendome, France).
8. R. Watling and C. Parks, "Theoretical Analysis of the Condensation of Hydrogen Peroxide Gas and Water Vapour as Used in Surface Decontamination," Pharm. Sci. Tech. 56 (6), 291-299 (2002).
9. Clarus "C" User Manual, STD2000-005, Rev. 4 (BioQuell Pharma, Andover Hampshire, United Kingdom, 2002).
10. Cycle Development Guide, STD2000-006, Rev. 1, (BioQuell Pharma, Andover Hampshire, United Kingdom, 2002).
11. VHP 1000ED Biodecontamination System Operator Manual, (STERIS Corporation, Erie, PA, 2002).
12. VHP 1000ED-C Biodecontamination System Maintenance Manual, (STERIS Corporation, Erie, PA, 2003).
13. D. Khorzad et al., "Design and Operational Qualification of a Vapor-Phase Hydrogen Peroxide Biological Indicator Evaluator Resistometer (BIER) Uni," Pharm. Technol. 27 (11), 84-90 (2003).
14. M. Ebers, MSDS No. A121, "Hydrogen Peroxide Solution (31%-35%)", STERIS, 19 February 2002.
15. 2 Vapor Monitor," Pharm. Eng. 18, (6), 66-76, (July-August 1998).