From Spore to Standard: How ISO 22441 Validation Compares to ISO 11135 (EtO) and ISO 11137 (Radiation)

The most common objection to VHP adoption among experienced validation teams is unfamiliarity with ISO 22441. For teams fluent in ISO 11135 for EtO or ISO 11137 for radiation, the structural parallels are exact. The biological indicator organism is the same. The SAL target is the same. The IQ/OQ/PQ lifecycle is the same. What differs is the method-specific parameters — and those differences are precisely defined.