After media fill run, What are the requirement for cleaning validation ?
dear Tapan,
the conditions under which the media batch is produced will dictate the cleaning requirements. So a full cleaning run consisting if cleaning and steaming might not be needed if the production will not require this. This depends on the manner the media is processed, is it filtered or treated during transport to the product, etc? Cleaning is regularly done, verified by the regular checks as swaps, etc. Steaming should always be considered as it gives an additional security for the clean state of your media equipment.
Dear Tapan
As Diederik said,after mediafill you should wash with water to omit the media residues and then you should check your equipment to ensure of cleaning. the best choice is to test the last rinse water by TOC.
Dear All,
What acceptance criteria/ limit do you apply for the rinse water? In other words at what level do you consider the rinse water to be clean?
Regards,
Simon
dear simon
in some documents has written it’s the bet result for cleaning if you have the last rinse water’s TOC 10% more than the water you have used for cleaning.
If you have validated any worst-case product on the line which was used for Media fill, i dont think you need do anything. However, you should include the media in your cleaning validation matrix and determine if the worst-case product can cover Media as well or not. If you determine that Media is worst-case product then go for validated by swabbing or rinsing methods