Can anybody help me in this isuue (Autoclave Validation). We have Autocleve (heaters). I performed 3 runs heat distrbuion (empty load) & three runs (full load). and it passed . during the penetration studay, the internal temperature didn/t reached the 121 C so i increased the temperature set point to be 123 C with the time, to get 121 +/- 1 c insdie the bottelss and to acheive 6 log reduction. My quasion is: Should I repeat the studies distribtion forfull and empty loads, or i directly go to penetration study (3 runs)?
HEAD OF VALIDATION