AAMI TIR76 Calculation Tool (CT) for Method VDmaxSD-S Values v2.0

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TIR76 extends the Method VDmax approach to sterilization dose substantiation by determining verification doses for SAL values of 10-6, 10-5, 10-4 and 10-3 and also allowing the use of 10, 30, or 90 product items in the verification dose experiment.

This tool, for a set of input values (average bioburden, SAL, SIP, sterilization dose to be substantiated, and number of product items to be irradiated in the verification dose experiment), calculates the appropriate VDmaxSD-S verification dose and dose augmentation values.

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Calculation Inputs - Part 1
A: Calculation Identifier (Optional):
B: Multiple or Single Production Batch Sterilization Dose Substantiation?

C1: SIP = 1.0 Average Bioburden (Batch 1)
C2: SIP = 1.0 Average Bioburden (Batch 2)
C3: SIP = 1.0 Average Bioburden (Batch 3)
D: Sterility Assurance Level (SAL)
10