To lay down the procedure for re-sterilization of Container which are not used within specified time.
Manufacturing Chemist, Q. A. Manage, Washing In charge
PROCEDURE : –
1. Reload the containers (Amp/vial) which are not used within specified time (24 hrs.) in D.H.S. From
Post sterilization buffer zone.
2. Remove these Containers from the D.H.S.from pre sterilization buffer zone and take them in washing
3. Rinse these Containers in Distilled water
4. Then again load these Containers in D.H.S. from pre sterilization buffer zone.
5. Switch on the D.H.S. & set the data In PLC as follows.
1. Exhaust temperature 130º c
2. Pre- Sterilization temperature 230º c
3. Sterilization temperature 240º c
4. Sterilization time 120 min.
5. Stabilization time 10 min.
6. Cooling Temp. (Start) 200º c
7. Cooling Temp. (End) 60ºc
6. When temp. is 60ºc, switch off the D.H.S. & open from Post sterilization buffer zone allow to cool the
7. Use the container for specified product.
|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)