SOP FOR CLEANING AND STERILIZATION OF FILLING MACHINE ACCESSORIES

 SOP FOR CLEANING AND STERILIZATION OF FILLING MACHINE ACCESSORIES

1.0 OBJECTIVE             

The objective of this SOP is to define the procedure for Cleaning & Sterilization of filling machine accessories. 

2.0 SCOPE                        

This Procedure is applicable for Cleaning & Sterilization of filling machine accessories in unit preparation area of production at Pharmaceutical Manufacturing Unit.

3.0 RESPONSIBILITY 

Officer / Executive – Production  

4.0 ACCOUNTABILITY 

HOD – Production 

5.0 PROCEDURE

5.1 Dismantle filling machine accessories aseptically from vial filling machine and keep all dismantled   machine parts in pass box installed between sterile corridor and unit preparation area

5.2 Person from unit preparation area will take out dismantled machine parts and wash those parts manually with plain purified water followed by using 0.1% Teepol solution. 

5.3 Above step should get repeated for one more time.

5.4 Finally rinse all parts with WFI. 

5.5 Intimate QA Department to collect the sample of final rinse water for wash water analysis. 

5.6 After getting release slip from QC Department, sterilize the filling machine   accessories as per validated load pattern  in autoclave. 

5.7 Unload the sterilized load at aseptic side and & keep it under LAF. 

5.8 Record the cleaning and sterilization details in log book. 

5.9 Frequency:  During Product Change Over / After 5 Batch of Similar Products in continuation / before processing of a batch to be manufactured in case after 12 hours from the completion of last Processed Product’s batch processing.    

6.0 ANNEXURE

NA

7.0 ABBREVIATION

SOP : Standard Operating procedure

QA : Quality assurance

QC : Quality Control 

WFI : Water for Injection 

 LAF: Laminar air flow

HOD: Head of department

8.0 REFERENCES

In-house.

Also, Visit:

B. Pharma Notes | B. Pharma Notes | Study material Bachelor of Pharmacy pdf

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B. Pharma PDF Books

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