EO cycle development
Optional Tests for EO cycle development
D-value determinations, Product D-value, Spearman Karber ANSI/AAMI/ISO 11138, USP 55
This test is performed on products inoculated with biological indicators and on process challenge devices. Note that the specified D-value by the manufacturer may not be achieved since the BI is included in the product and the testing conditions are not the same than the manufacturers. 100% EO gas is used for all the BI resistance determination tests. Samples need to be small enough to fit in the BIER vessels. Steam and EO sterilization can be performed.
Include the BI manufacturer's certificate of analysis when submitting samples. NLI recommends clients to submit at least 104 BIs for this test (includes population verification testing).
D-value determinations, Product D-value, Stumbo method ANSI/AAMI/ISO 11138, USP 55
This test is performed on products inoculated with biological indicators and on process challenge devices. Note that the specified D-value by the manufacturer may not be achieved since the BI is included in the product and the testing conditions are not the same than the manufacturers. 100% EO gas is used for all the BI resistance determination tests. Samples need to be small enough to fit in the BIER vessels. Steam and EO sterilization can be performed.
Include the BI manufacturer's certificate of analysis when submitting samples. NLI recommends clients to submit at least 104 BIs for this test (includes population verification testing).
D-value determinations, Steam BIER ANSI/AAMI/ISO 11138-3, 11138-1, 11138-2, USP 55
This test is performed on organisms. The procedure involves the isolation and identification of the organisms to ensure a pure culture. Organisms are then grown on agar plates. The organism is harvested and the concentration adjusted to obtain approximately 106 organisms in the suspension. Spore strips are then prepared using this suspension and filter papers. The filter paper is then placed into glassine envelopes and the "BIs" are exposed to incremental exposure times.
D-value determinations, Steam BIER, Spearman Karber ANSI/AAMI/ISO 11138-3, 11138-1, USP 55
This test is performed on biological indicators only. Note that the specified D-value by the manufacturer may not be achieved since the testing conditions (including the vessel) are not the same than the manufacturers.
Include the BI manufacturer's certificate of analysis when submitting samples. NLI recommends clients to submit at least 104 BIs for this test (includes population verification testing).
D-value determinations, Steam BIER, Stumbo method ANSI/AAMI/ISO 11138-3, 11138-1, USP 55
This test is performed on biological indicators only. Note that the specified D-value by the manufacturer may not be achieved since the testing conditions (including the vessel) are not the same than the manufacturers.
Include the BI manufacturer's certificate of analysis when submitting samples. NLI recommends clients to submit at least 104 BIs for this test (includes population verification testing).
D-value determinations, EO BIER, organism isolate ANSI/AAMI/ISO 11138-2, 11138-1, 11138-2, USP 55
This test is performed on organisms. The procedure involves the isolation and identification of the organisms to ensure a pure culture. Organisms are then grown on agar plates. The organism is harvested and the concentration adjusted to obtain approximately 106 organisms in the suspension. Spore strips are then prepared using this suspension and filter papers. The filter paper is then placed into glassine envelopes and the "BIs" are exposed to incremental exposure times.
D-value determinations, EO BIER Spearman Karber ANSI/AAMI/ISO 11138-2, 11138-2, USP 55
This test is performed on biological indicators only. Note that the specified D-value by the manufacturer may not be achieved since the testing conditions (including the vessel) are not the same than the manufacturers. 100% EO mix is used for this test.
Include the BI manufacturer's certificate of analysis when submitting samples. NLI recommends clients to submit at least 104 BIs for this test (includes population verification testing).
D-value determinations, EO BIER, Stumbo ANSI/AAMI/ISO 11138-2, 11133-2, USP 55
This test is performed on biological indicators only. Note that the specified D-value by the manufacturer may not be achieved since the testing conditions (including the vessel) are not the same than the manufacturers. 100% EO mix is used for this test.
Include the BI manufacturer's certificate of analysis when submitting samples. NLI recommends clients to submit at least 104 BIs for this test (includes population verification testing).
