Packaging leak tester 15.300.043

for the pharmaceutical industry

SO11607‐2‐2006 (Validation requirements for forming, sealing and assembly processes), requires Operational Qualification (OQ) of packaging devices to be carried out and documented. The OQ is requiring providing proof of: Intact seal for a specific seal width No channels or open seals No punctures or tears in seals No material delaminating or separation The OQ needs to be carried out on a daily basis to release the packaging device before use. For this purpose Famos offers two different seal tests: the Famos push indicator dye test and the Famos seal test. The push indicator dye test can be used for both laminate and Tyvek packaging material. This test uses ink to test the quality of the seal. In contrary to many other ink tests that are available in the market, the Famos push indicator dye test does not use any pipettes or other objects, so it will not damage the seal. The Famos seal test can only be used for laminate packaging material. The seal test is a paper test. The parts which are sealed together are showing a darker area than the surrounding area in order to make sure that irregularities in the seal are easy to see and the complete seal can be interpreted more easily. The seal test offers various fields for documentation. When the sealer has been released for use, the seal test is being documented. For this purpose Famos offers a laminated folder.