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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