Conventionally plastic blow fill seal ampoule strips have been leak tested by sample visual inspection or the Methylene Blue dye test. These methods may now be finally replaced by a clean, highly precise, non-destructive leak tester which may be easily and accurately validated to very small micro leaks.
The latest development at Bonfiglioli Pharma is the combined visual inspector and leak tester PKVS Combi. At infeed two cameras are installed to perform a visual check of the upper and lower side of the ampoule strip. This check is a cosmetic defect inspection of the strip which will then also be inspected by a third camera that inspects the lot number and expiry date at the base of the ampoules. An in-process check is also made automatically by special force sensors on each ampoule of the card.
After a stipulated time, one strip is picked automatically by a mechanical arm and inserted in a testing station where the ampoules will be compressed and measured for the force. This will provide data on the plastic distribution and fill volume in each ampoule. The strips will then proceed to the leak testing stations via a pick and place mechanism, where the strip is inserted in a testing chamber. Special sensors analyse the pressure pattern around the strip when applied under vacuum and will reject faulty leaking strips accordingly.
The PKVs machine is fully computerised utilising a SCADA platform. The software is easy to operate and includes utilities such as a products database, statistical reports etc. A printer is also installed for printing test results and parameters. The machine includes an auto self test system whereby the machine is self-challenged as frequently as desired to assure 100% reliability. Also installed is an auto cleaning testing pocket (ACP) mechanism whereby the testing chambers are cleaned automatically when any spilling occurs from a reject strip, thus eliminating subsequent false rejects.
High output rates may easily be reached depending on the number of testing heads, which makes it ideal for most FFS lines operating worldwide. Laboratory semi-automatic models are also available.