EO Sterilization Re-validation

If you perform an annual documentation / process review (review of past years' sterile load lot information), with no problems noted, documented, then the following is required every two years, assuming nothing in your process / product has had major changes:

The minimum re-validation requirements of ISO 11135-1:

• Re-validate PCDs (verify that the ½ cycle BIs are more resistant than product bioburden);
• Bioburden measurement (should be doing quarterly; no changes in average levels);
• EO residuals (no subtle changes in product / process / packaging that could increase residuals)
• 1 Half Cycle (verify overkill)
• 1 Full Cycle (also used for the EO residuals testing); if acceptable / sterile, can be released for sale.

Also every two years, a full EO validation is required, e.g., 1st year:  Initial full validation, 2nd year:  If OK review, then abbreviated V&V (per above); 3rd year:  full validation; 4th year:  If OK review, then abbreviated V&V (per above); and so on.

John E. Lincoln               jel@jelincoln.com