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



Table II.Control specification of Fedegari and Steris resistometers.
Fraction negative. In each resistometer, D 121-values were determined (in triplicate) on the spore-strip BIs. In the Fedegari resistometer, D 124 and D 129-values were determined (in triplicate) on the spore-strip BIs.

In each resistometer, D-values were determined (in triplicate) at three temperatures using self-contained and ampul BIs. All fraction-negative data were collected according to ISO 11138 (2). The fraction-negative method involves subjecting the BIs to a series of incremental exposure times followed by assay testing for growth or no growth. Using these data, Z-values were calculated. Testing was as follows:

  • BI lot S1—D 121-value determined in triplicate in each of the three resistometers
  • BI lot S1—D 124 and D 129-values determined in triplicate in Fedegari resistometer
  • BI lot SC1—D 121, D 124, and D 127-values determined in triplicate in each of the three resistometers
  • BI lot SC2—D 121, D 124, and D 127-value determined in triplicate in each of the three resistometers
  • BI lot SC3—D 121-value determined in Fedegari resistometer
  • BI lot SC4—D 121-value determined in Fedegari resistometer
  • BI lot A1—D 121, D 124, and D 129-values determined in triplicate in each of the three resistometers.


Figure 6
Exposures above 129 C were not performed. Although the resistometers are capable of operation above this temperature, ISO 11138 states that for Z-value calculation, temperatures "in the range of 110 C to 130 C" shall be used.

Results


Figure 7
Parametric analysis of resistometers. The control accuracy of each resistometer is listed in Table II, along with the ISO specifications. Although there were a few minor deviations from the standard (e.g., temperature and pressure range), all three resistometers were within specifications.


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