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*Particle shedding qualification* page 8

Thirdly, the validation shoul be accure that the filter does not affect the original drug product's attributes.
This implies adsorption studies, particle shedding qualification and a study of extractable substances.
Fourthly, processes h as proress sterilisation procedures (Autoclaving or.
Steaming In Place), use of critical instrument (i.e. automatic filter integrity testers), and bioburden (environmental and product) monitoring have to be qualified.



When certification documents can be supplied, certification protocol will only be provided if it's required by Customer standards Many tests (like compatibility and particle shedding studies) are reported in Millipore's validation guide for the specific devices.