Article of the month Jan 09 - Writing an Effective Cleaning Procedure

Writing an Effective Cleaning Procedure : A successful start to cleaning process of the equipment.


During early stages of the cleaning method validation or after introduction of the new process equipment or cleaning equipment the egg and hen dilemma ( Cleaning SOP first or cleaning validation first) is normally observed. To start the cleaning method validation, the approved cleaning method (Standard operating procedure for cleaning of the equipment) is required and to write the Standard operating procedure for cleaning ( SOP), the validation is required.

Imagine a new drug product manufacturing facility, or new equipment train or introduction of the new process equipment and still not in use. The seeding of the cleaning method shall be done at this stag itself to have the strong pillar for the cleaning method with the aid of the accessories installed on the process equipment for the cleaning (e.g. Spray ball for the tank cleaning) or by using the dedicted equipment required for the cleaning like Cleaning in Place( CIP) unit, or ultrasonic bath for the very small product contact surface accessories.

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Nice article Anil - Keep up the good work.

Thank you

Thanks Chris,


There are some interesting points in this nice article, that I will share with my work friends

Good article.

Thanks and Good work

May i know the rationale of using sodium chloride?


Dear Gokeeffe
Good Article with useful information.