PURPOSE: 

To lay down the procedure for re-sterilization of Container which are not used within specified time.

RESPONSIBILITY:        

1. Manufacturing Chemist
2. Q. A. Manager
3. 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

    area.

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.

01. Exhaust temperature                             130º c

                   2. Pre- Sterilization temperature               230º c

                   3. Sterilization temperature                       240º c

                   4. Sterilization time                                   120 min.

02. Stabilization time                                   10 min.

 03. Cooling Temp. (Start)                            200º c

 04. 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

     container

7. Use the container for specified product.

                        (Review date on or before 12 months from date of authorization)