ISO 11135-1:2014 is the international standard for sterilization validation for Ethylene Oxide (EO) or (EtO) Sterilization validation. The standard describes multiple approaches of validation: 1. Overkill approach, 2. Single lot release, 3. Parametric release. Among these Overkill Approach is most commonly used and is covered in this template provided by Maven Profcon Services LLP.
This ETO validation includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). For initial validation a typical PQ includes:
- Process Challenge Device (PCD)
- Bioburden test
- EO residual test (as per ISO 10993-7)
- Fractional Cycle (at least one)
- 3 Half Cycles
- 3 Full Cycles (or 1 Full Cycle, if performed in parallel with the three half-cycles)
This template is written specifically for early-stage medical device companies and are audit ready and are written by highly experienced professionals. Click below to get a preview of this template.
Price: $650
