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Pre-Validation Studies
Worst-Case Study
Load Product into Noxilizer totes
Run Cycle 2x Based on Lethality & Cycle Parameters Established in Feasibility Study
Ingress & External Residuals Assay Results Reported on Day 0
Ingress & External Residuals Assay Results Reported on Day 30
Final Report
- Since most Feasibility Studies are done in a development sterilizer, rather than in an RTS NO2 Production Sterilizer, this study will provide confidence that the ingress and external residuals results seen in Feasibility are directionally correct if the cycle parameters increase when the product moves to a larger production chamber.
Comparative Resistance Study
Select Various Noxilizer EPCD Designs Based on IPCD
Prepare a Fully-Loaded Chamber with IPCDs & EPCDs
Run Various Lethality Cycles
Report IPCD/EPCD Lethality Results
Final Report
- This study provides IPCD and EPCD comparative resistance guidance before validation begins.