Validation Center

Overview of Sterile Filtration Validation

Sterile filtration validation includes two parts: performance validation and process validation of the sterilizing filter. These two parts can't replace each other and should be completed independently.

The performance confirmation of the sterilizing filter itself is generally completed by the filter manufacturer ; the verification of the sterilizing filtration process can be completed by the user of the filter or an entrusted testing agency (for example: the manufacturer of the filter or a third-party laboratory), but The filter user should finally ensure that the operating parameters and allowable extreme values in the actual production process have been covered during verification, and there are corresponding supporting documents.

Main Point

1. The verification documents of different filter manufacturers are generally not interchangeable, and the sterile filtration verification documents of the same material of the same manufacturer are often not directly interchangeable, unless there are reasonable statements or document support.

2. If two or more different manufacturers provide filters of the same material or different materials, or filters of the same material (different film-forming processes) from the same manufacturer during the production process, the verification should be carried out separately. This is because it is possible that the film-forming process is different, the additives are different, and the structure of the film may not be exactly the same.

Validation Center

Overview of Sterile Filtration Validation

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