AFITT ensures the integrity of sterile filters
With AFITT, Agidens has an automated solution that combines filter testing and filter drying, with documented results afterwards – all in line with FDA and EU GMP requirements.
Importance of filter integrity testing
To check the sterilization operation of the sterile filter, an integrity test is needed to be executed with AFITT. Such integrity test is a non-destructive test to check if the sterility of the filter can be guaranteed for a sterile product. Only if the filter succeeds the integrity test, the produced medicine can be considered sterile and is allowed for patient usage. Furthermore, the integrity test is necessary to validate the sterile filtration process.
AFITT by Agidens
AFITT is entirely tailor-made: the designs are adjustable to the number and the types of filters used in the production environment. Agidens Life Sciences ensures a full integration of AFITT in the existing production process.
- Reliable and repetitive process: because of automation and standardization, Agidens guarantees that the integrity test is performed in a correct and repetitive way.
- Automated process: several filters are being tested and blowdried in series.
- Documented process: every test must meet the ASTM F 838-05 legislation. With AFITT it is not possible to manipulate the reports of the test results, an additional asset for tracking, compliance and validation.
- Gaining time: sequential testing of several filters is possible in a shorter time span compared to testing and to blow-dry of all the filters separately.
- Resources: the number of manual actions are reduced by the automated process, which decreases the operational cost.
- System integration: integrating the AFITT software in the central data management system assures.
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