AFITT

AFITT ensures the integrity of sterile filters

In the Life Sciences industry, the formulation of sterile fluids like parental medicines and vaccines sets high purity and sterility criteria which can only be achieved by the right technology and process know-how. 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.
 

HOW DOES AFITT WORK

For the Pharma and Life Sciences industry, AFITT contributes added value in the production environment. The sterile filters used in production undergo an integrity test performed by AFITT: first the filter cartridges are soaked in a hydro-alcoholic solution. Afterwards, the cartridges are mounted in their housings in the AFITT filter test table.

The integrated filter testing device (e.g. Palltronic Flowstar IV & MUX) controls the desired compressed air pressure which makes sequential filter testing possible. The used test principles are Forward flow, Bubble point or Pressure hold-testing.

After the integrity test, AFITT switches to the necessary pressure to blow-dry the filter with clean air. This way the sterility of the used filter is guaranteed, in line with FDA and EU GMP requirements for sterile production of medicines.

FUNCTIONALITIES

  • Integrity test
  • Blow-drying
  • Connection with external systems


BENEFITS OF AFITT

  • 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 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.
 

IMPORTANCE OF FILTER INTEGRITY TEST

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.

MODULAR BUILDABLE FILTER TEST TABLE

AFITT is entirely tailor-made: the designs are adjustable to the number and the types of filters used in the production environment. Agidens ensures a full integration of AFITT in the existing production process.


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