Understanding Biological Indicator Grow-Out Times—Part II - Pharmaceutical Technology

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Understanding Biological Indicator Grow-Out Times—Part II
In Part II of a series, the authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.

Pharmaceutical Technology
Volume 37, Issue 6, pp. 52-59


1. J.R. Gillis et al, Pharm. Technol. online http://www.pharmtech.com/pharmtech/Peer-Reviewed+Research/Understanding-Biological-Indicator-Grow-Out-Times/ArticleStandard/Article/detail/651903/, Jan. 2, 2010, accessed May 6, 2013.

2. FDA Guide for Validation of Biological Indicator Incubation Time (1986).

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

4. ISO 11138–1: 2006, Sterilization of health care products—Biological indicators—Part 1: General requirements, (ISO, Geneva, 2006).

5. ISO 14161: 2009, Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results (ISO, Geneva, 2006).

6. ISO 18472: 2006, Sterilization of health care products—Biological and chemical indicators—Test equipment (ISO, Geneva, 2006).

7. H.O. Halverson and N.R. Ziegler, J Bacteriol. 25 101-121 (1933).

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

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


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