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EQUIPMENT CLEANING PROCEDURE SOPS


1.0   PURPOSE

To avoid the product contamination as per cGMP.

2.0  SCOPE

This procedure applies to all manufacturing equipment used in Manufacturing (Mixing Stirrers, Blenders, Mixers, Scoops, Buckets, and Spatulas etc.).

3.0  RESPONSIBILITY

Ø  Production Supervisor
Ø  General Workers

4.0   PROCEDURE

Ø Wear protective garments, gloves & mask etc if required before cleaning operation.
Ø Clean the equipment from solid residue with water first with aid of brush.
Ø Clean next with ZIP detergent solution (20% solution) or any other suitable detergent & soak them if necessary in detergent solution for 10 minutes.
Ø Wash detergent off the equipment with hot water to remove all traces of detergent.
Ø Airs dry the equipment then rinse with germicidal Alcohol solution (IPA 70%)
Ø Dry in air & affix “Cleaned” Label before covering with plastic sheet or storage in the cabinet.

5.0   QUALITY FORMS AND RECORDS

Machinery/Equipment Cleaning Log Book

6.0   DISTRIBUTION

Ø  Head of Operation
Ø  Q.A Manager
Ø  Production Manager
Ø  Q.C Manager
Ø  Production Pharmacist


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