Innovation in Biological Indicator Evaluator Resistometer Vessel Technology - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Innovation in Biological Indicator Evaluator Resistometer Vessel Technology
The authors examine advances in the design and the application of biological indicator evaluator resistometer vessels used to measure the resistance of bacterial spores in monitoring sterilization processes.


Pharmaceutical Technology


Conclusion


Figure 13
Operational parameters of the Fedegari are not identical to the Steris resistometers; however, data collected during this study demonstrated that the Fedegari vessel performs parametrically as a resistometer. Results from the various resistometers were comparable with respect to the measured resistance of the tested indicators. Less variation was obtained with the Fedegari BIER for all but the ampul BI. Slight differences in determined resistance between the BIER units are to be expected and are typical of replicate results from any single BIER unit. The Fedegari BIER provided equivalent performance to the more traditional BIER design in a more versatile and cost-effective system.

References

1. ANSI/AAMI/ISO 18472:2006, Sterilization of Health Care Product—Biological and Chemical Indicators: Test Equipment (International Organization for Standardization, Geneva, Switzerland).

2. ANSI/AAMI/ISO 11138-1:2006, Sterilization of Health Care Product—Biological Indicators, Part 1: General Requirements (International Organization for Standardization, Geneva, Switzerland).

James Agalloco is president of Agalloco & Associates (Belle Mead, NJ). Kurt McCauley is the research and development manager and John R. Gillis* is the president and CEO of SGM Biotech, 10 Evergreen Drive, Suite E, Bozeman, MT 59718, tel. 406.585.9535, fax 406.585.9219,
, http://www.sgmbiotech.com.

*To whom all correspondence should be addressed.

<WEBLINK>
For additional resources and online exclusives on this topic, visit http://pharmtech.com/.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
28%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
9%
All of the above.
45%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology,
Click here