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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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

References

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
29%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here