The D-value Determination test ascertains the resistance of a biological indicator (BI), product, or environmental isolate to sterilization by determining its resistance to a sterilant such as ethylene oxide, dry heat, or saturated steam under pressure. This test can also be used to determine approximate cycle times. Newly purchased BIs, inoculated actual product, pharmaceutical products, and isolates of microorganisms recovered during testing should be tested.
USP <55>, <71>, <1035>, & <1211> , ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 14161 and ANSI/AAMI/ISO 11138 each give guidance for the various methods used to calculate D-values. Equipment performance requirements are outlined in ANSI/AAMI/ISO 18472 for accurate determinations of the D-value.
Nelson Labs have steam and EO BIER vessels designed to meet these requirements. Our highly qualified personnel are knowledgeable in the Stumbo-Murphy-Cochran, Spearman Karber, Limited-Spearman-Karber, Holcomb-Spearman-Karber, and Limited Holcomb-Spearman-Karber methods.
- ANSI/AAMI/ISO 11135
- ANSI/AAMI/ISO 14161
- ANSI/AAMI/ISO 11138
- ANSI/AAMI/ISO 18472