What is Cleaning in Pharmaceutical Manufacturing Industry?

 

What is Cleaning in Pharmaceutical Manufacturing Industry ? What are the Classification of Cleaning?

Cleaning - Cleaning is the process of removing the residues from manufacturing equipment/facilities below a predetermined level.
In this context, the role of current Good Manufacturing Practice (cGMP) is the prevention of products cross-contamination by apply and validate cleaning programs, which consists in the documented evidence that cleaning processes and procedures applied to shared facilities will obtain residues on equipment surfaces under pre-established acceptable limits.

Term cleaning is this document that is primarily used for the cleaning of process manufacturing equipment in the pharmaceutical industries.

Cleaning is usually of three types which are given as follow,

· Type A Cleaning

· Type B Cleaning

· Type C Cleaning


Type A Cleaning

Type A cleaning is also known as minor cleaning or batch to batch cleaning and it is a short cleaning activity. In type A cleaning, washing of equipment or area is not required, just the area is cleared and equipment are cleaned from outside with lint-free cloth. Type A cleaning is performed during the following cases,


Between Batches of Same product
Same product but strength is changed in Ascending order mean from lower strength to higher strength.
Minor Preventive maintenance in which parts which are in direct contact with the product are not exposed.

Type B Cleaning

Type B cleaning is also known as major cleaning. It is a long activity and all the equipment and area is washed during Type B cleaning. All the equipment are washed with food-grade detergent and rinsed with purified water.Then all the equipment are dry with a lint free cloth and are disinfected with 70% IPA.


Type B cleaning is performed during following cases,
During product change over.
During Same product but strength is changed in descending order mean from higher potency to lower potency.
Same product but color is changed.
Same product but the flavor is changed.
Major preventive Maintenance.
When area is used after expiration of cleaning validation time of equipment.

Type C Cleaning

Type C cleaning is the general cleaning which is performed at the end of the shift and where the work is to be started again on the next day.In this type of cleaning all the materials from line are properly closed or stored in containers or polythene bags. Any component or material is not left exposed.

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