Cleaning Validation for a Dedicated Facility

Quality Assurance
1

Hello experts,

I would like to ask if it really need a cleaning validation activity for a dedicated facility… if not what documents do i need to submit to regulators. Also if it is a dedicated facility, can i clean the equipment only once a week?..

thanks

2

Cleaning validation is equally important for a dedicated product manufacturing facility.This is to ensure that carry over or built up residues of the product and / or impurities of previous batch (es) are not mixed with / carried forward to the subsequent batches of the same product beyond acceptable limits.
This cleaning validation should be same as that of product change over.
However, such rigorous claeaning may not be required after every batch change over. The frequency of such cleaning should be established based on specific studies. The frequency of rigorous cleaning can be based on maximum number of batches of a product manufactured or the maximum span of time (number of days production equipment are engagaed to produce these batches).
In between 2 batches of the same product the cleaning should be simple followed by visual checks of the cleaned equipment.

3

You need:

Maximum campaign length validation

Clean holding time validation

4

Dear ,
As there is no question of carryover hence CV not applicable however following studies will be require which covers microbiological aspects as follows:.

Cleaned equipment hold time study
Dirty equipment hold time study
campaign hold time study

Thanks

5

All above aspects are a part of cleaning validation (CV). You should consider both chemical and Microbiological aspects in CV and when establishing the Acceptance criteria.