ABSTRACT
Filter suppliers also submit quality certificates with every filter, which list release criteria and the attainment of such. Membrane casting for a sterilizing grade filter is one step within the production of a sterilizing grade filter. Evidence has to be given and documented to show the filter is performing to the set requirements under the environmental circumstances. Depending on the equipment deliver qualification documentation can be elaborate due to the subcomponents of the device. For single-use equipment, for example, raw material controls and definitions may be included in the qualification documentation or extractable profiles. In instances of complex automated equipment, for example, fermentation equipment, factory acceptance tests are crucial release criteria before the system is shipped to the client. Maintenance and continued testing and verification are the responsibility of the end user, who may seek assistance from the equipment manufacturer or its own maintenance department.
