To lay down a procedure for the maintenance in case of steam sterilization .
1. Section Supervisor/Shift In-charge
2. Maintenance Engineer
3. Prod. Chemist
Autoclaving is a moist heat sterilization technique. Required sterilization temp is 121 C & 15 PSI pressure which is maintained for 30 minutes. Equipments /vessels to be sterilized must be cleaned . All the mountable parts like Syringes & needles , latex rubber etc. are kept in stainless steel container with lid on the top. Validate the Membrane filter by bubble point test .Both terminals of membrane filter. pressure vessel and nitrogen filter must be covered with butter paper.
2. PURIFIED WATER IP.
3. ELECTRIC CONNECTIONS.
1. Check water level of autoclave make up with purified water IP.
2. Place the load in the autoclave.
3. A signaled indicator marked with date and batch no. is kept along with objects to be sterilized.
4. Close lid of the autoclave.
& PLUGS BY AUTOCLAVE
5. Switch on the autoclave and document Date /Time / Name of operator in the BMR.
6. Release air at 5 PSI pressure by opening steam control valve for 5 minutes.
7. Note down time in BMR when the autoclave attains 121 C temp & I5 PSI pressure maintain it for 30 minutes.
8. Switch off the autoclave, note down the time, open steam control valve to release steam.
9. Open autoclave when it has cooled down . Check colour of signaler indicator. It should have turned dark gray to black in colour. Paste it in BMR.
10. Put a tag on the sterilized goods mentioning date /time of sterilization & time before which they must be consumed.
11. Transfer sterile goods to sterile area.
|Author: (Production Manager)||Checked by: (QA Manager)||Authorized by: (Director Administration)|
|Date:||Date :||Date :|
(Review date on or before 12 months from date of authorization)