Packaging Tightness Tester, detection type: vials ampoules, pre filled syringes, cartridge bottles, infusion bagsBFS packaging, pharmaceutical industry sealing integrity leak detection solutions. compliance fDA 13287 standard: meet one of USP 1207 test methods: non-destructive testing method.

・ Comply with USP <1207>, ASTM F2338 standards and FDA standards.
・ Semi-automatic detection, suitable for small batch and multi-variety testing.
・ Non-destructive non-destructive testing, high accuracy, repeatability, sensitivity.
・ The instrument is used for vacuum pressure ,pressure decay difference detection.
・ The leak rate can be automatically converted into defect aperture μm.
・ Database storage of test results for easy quality management.
・ Database storage of test results for easy quality management.
・ Touch-type man-machine interface, simple and quick operation: after setting/selecting the test program, only need to manually put in/take out the test sample.

ADVANTAGE FUNCTION

・ Automatically test the flow rate and change the aperture size during the whole process.
・ Automatic leak flow calibration function.
・ Equipped with standard leaks (standard positive bottles, with third-party certification).
・ Four-level user authority management meets FDA 21CFR PART 11 requirements.
・ With audit trail function.
・ Split design, the test chamber is located above the host, and various test chambers can be provided according to different product types.
・ We also provide users with supporting services related to tightness testing, including positive bottle(mould) production, standard leak rate/annual leak verification, new sample mold customization, sample methodological parameter development and verification, etc.
・ The test cavity is customized according to customer needs to ensure that the test cavity is fully matched with the customer's product, and rapid and sensitive testing.