Understanding Biological Indicator Grow-Out Times - Pharmaceutical Technology

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Understanding Biological Indicator Grow-Out Times
This study used biological indicators containing   Geobacillus stearothermophilus spores and a new technology to continuously monitor incubated BIs and record nonsterile results.

Pharmaceutical Technology
Volume 34, Issue 1


1. ISO 11135-1: 2007 (ISO, Geneva, 2006).

2. ISO 17665-1:2006 (ISO, Geneva, 2006).

3. ISO 14161:2000 (ISO, Geneva, 2000).

4. ANSI/AAMI ST79:2006 (AAMI, Arlington, VA, 2006).

5. USP 32–NF 27 General Chapter < 1211 >, "Sterilization and Sterility Assurance of Compendial Articles," 720–723.

6. FDA, 21 CFR Part 820: Quality System Regulation. Medical Devices: Current Good Manufacturing Practice (cGMP); Final Rule Oct. 7, 1996.

7. ISO 11138-1:2006 (ISO, Geneva, 2006).

8. CDRH, FDA Guide for Validation of Biological Indicator Incubation Time (Do. 98984, 2007).

9. The ISO/TC198/WG 04 Biological Indicator working group has been assigned a new work item proposal ISO/TS 16342 "Sterilization of healthcare products – Biological indicators – Method for validation of a reduced incubation time for a biological indicator."

10. H. Chick, J. Hygiene, 8, 92–158, (1908).

11. W. D. Bigelow, J. Inf. Dis., 29, 528–536 (1921).

12. O. Rahn, Biodynamica Monograph 3, Luyet, B. J., ed, (1945). Republished in Selected papers on the Microbiology and Engineering of Sterilization Processes, I. J. Pflug, ed. (Environmental Sterilization Laboratory, Minneapolis, 5th ed. 1988) pp. 1–16.

13. I.J. Pflug, Microbiology and Engineering of Sterilization Processes (Environmental Sterilization Services, Minneapolis, MN, 11th ed., 2003).

14. G.A. Mosley, BI & T, 36 (6), 451–454 (2003).

15. ISO TR11139:2006 (ISO, Geneva, 2006).

16. H.O. Halverson and N.R Ziegler, Journ. of Bacteriology 25, 101–121 (1933).

17. G. Mosley, Pharm Micro Forum Newsletter, 14 (5), (2008).

18. I.J. Pflug, R.G. Holcomb, and M.M. Gomez, "Thermal Destruction of Microorganisms," in Disinfection, Sterilization, and Preservation, ed. S. Block (Philadelphia: Lippincott, Williams & Wilkins, 2001) pp. 79-129.

19. L. I. Katzin,.A. Sanholzer, and M.E. Strong, J. Bacteriol., 45, 265–272 (1943).

20. C. R. Stumbo, J. R. Murphy, and J. Cochran, Food Technology, 4,321–326 (1950).

21. A. D. Russell, The Destruction of Bacterial Spores (Academic Press, London, 1982).

22. A. Hurst and G. W. Gould, The Bacterial Spore 2 (Academic Press, London, 1983).

23. ISO 18472:2006. (ISO, Geneva, 2006).

24. ISO 11138-3:2006. (ISO, Geneva, 2006).


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