Innovation in Biological Indicator Evaluator Resistometer Vessel Technology - Pharmaceutical Technology

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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.

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