Standard Operating Procedure For Re- Sterilization Of Containers Which Are Not Used Within Specified Time

by Pharmadocx Consultants


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


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)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

14 June 2023

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