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."

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

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

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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.

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

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

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


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