Using the latest technology, the Bonfiglioli Pharma Research & Development team is constantly working at offering the pharmaceutical industry with testing solutions, enabling manufacturers to produce a product that complies with today's stringent quality control regulations.
The LF-SY is a semi-automatic leak tester. Each syringe is placed in a test base as shown in the photograph. The testing cycle is performed in three steps. The test base rotates 90 degrees to position itself under the left linear displacement transducer whereby a first reading of the rubber stopper position is recorded. The test base is then rotated to be placed under a chamber where the syringe sealed into two test chambers. The first chamber is sealed on the top side of the flange and the other chamber is sealed at the bottom side of the flange, therefore creating an upper test chamber and a lower test chamber.
The upper test chamber is subjected to a vacuum. The rubber stopper will be supported from above as not to rise due to the vacuum during the test. The lower test chamber is subjected to a pre defined pressure. If any micro leaks are present below the flange the syringe will get pressurised. After the chamber opens the rubber stopper will get displaced due to the inside pressure. If no leak is present the rubber stopper will remain as in the pre test position. The test base is then rotated to the right linear displacement transducer whereby a final reading of the rubber stopper position is recorded. If any displacement is recorded then the syringe will be rejected. Whether the test result is good or bad, the operator interface shows the result clearly on the screen accordingly.
This machine is fully computerised using a SCADA platform. This is an easy to operate software including utilities such as test results, product database, statistical reports etc. A printer may also be installed for printing test results and parameters. All necessary validation documents are available.