Cleaned Equipment Hold time study

Production
1

I want to perform Cleaned equipment hold time study for equipment i.e. reactor.

Please guide me for same matter.

How to perform cleaned equipment hold time study and what type of content to be mentioned in protocol?

2

Cleaning hold time study : In order to provide the desired clean equipment hold time used in the process should be cleaned after batch completion and hold for 48 hours after batch to batch cleaning.
rinse the equipment with purified water and analyze for chemical and microbiology immediately after cleaning and again after 48 hours of hold time. The quality of the purified water should be similar and meet the established acceptance criteria.

Study shall be executed in triplicate

Chemical analysis and microbial analysis to be carried out
TMC and Test for pathogens and others

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3

Thank you sir.

I want to add some more.

What is the purpose of cleaning hold time study?
Is it only for removal of Microbial?

4

Hi,
Elimination of chemical and microbial residues, is the goal of the cleaning validation itself, on the other hand the main purpose of the validation of the cleaning hold time, is to ensure that the equipment and the premises keep in their state clean as long as possible, in order to use them in the processes which saves us cleaning time.

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5

Thanks sir…

6

Sir, Can i conduct CEHT for same equipment which was studied in DEHT?

7

Yes u can…

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8

Sure, because the scope are different. The CEHT help you to control how much time you equipment is stable between productions or need of recleaning.