The D-value Determination test determines or verifies the resistance of a biological indicator (BI), product or environmental isolate to a given sterilization process under pressure, such as ethylene oxide, dry heat or saturated steam. This test can also be used to determine approximate cycle times. Newly purchased BIs, inoculated real product, pharmaceutical products and microorganism isolates recovered during testing can be tested.
USP <55>, <71>, <1035>, & <1211>, ANSI / AAMI / ISO 11135, ANSI / AAMI / ISO 14161 and ANSI / AAMI / ISO 11138 each for various methods used to calculate D- The values that provide guidance. Equipment performance requirements for accurate determination of the D-value are summarized in ANSI / AAMI / ISO 18472.
EUROLABhas both steam and EO BIER containers designed to meet these requirements. Our qualified staff is knowledgeable in the Stumbo-Murphy-Cochran, Holcomb-Spearman-Karber and Limited Holcomb-Spearman-Karber methods.
D-value Determination testing mainly includes the labeled D-value of BIs, confirming their suitability for use, and testing of inoculated products, process testers (PCDs) and bioburden, environmental monitoring or product sterility.
The D-value or decimal reduction time is the time it takes to reduce a microbial population by 1 logarithm or 90% of the initial value under certain conditions (eg, Sterilant concentration, exposure temperature, relative humidity, package configuration).
In this test, samples are placed in the BI Assessment Resistance Meter (BIER) container, allowing equal exposure on all sides. Multiple variables are performed under the same parameters and the only variable is time. After each exposure, samples are tested for sterility or tested for the number of spores surviving. Number of cycles, intervals between cycles, choice of sterility test or population count, and calculations depend on the choice of the D-value method.
When testing is performed to verify the manufacturer's labeled D value, it is important to apply the same method used by the BI manufacturer due to inherent differences in BIER vessels, change in resistance due to growth environment, storage and transport, and testing. methods. USP and ISO 11138 require third-party verifications to be within 20% of the manufacturer's tagged claim.
Please include the BI manufacturer's certificate of analysis when submitting the samples.
EUROLAB, with its highly expert team and internationally accredited laboratories, D-Value Determination Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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