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The objective of Cleaning Validation Master plan of equipment, utensils, components and areas is

 

·                     To establish sufficient documented evidence to assure that, cleaning procedures can repeatedly and reproducibly remove residue of the subjected product-within established acceptance limit. The acceptance limit is maximum allowable quantity of product residue, which does not affect quality and safety of the subsequent product to be manufactured, by using same equipment and facility.

·                     To establish acceptable time limit for storage of cleaned equipment, utensils and components after cleaning (Cleaned Equipment Hold Time Study). Equipment are not expected to be free from all microorganisms, particularly when the final stage in cleaning does not involve final rinsing with sterile water for injection. The objective shall be to demonstrate that there is no microbial proliferation in equipments during storage.  

 

The main purpose of cleaning validation master plan is to set up guideline to establish cleaning, sampling, testing procedure and residue limits that are practical, achievable, and verifiable to assure safety.

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