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
