The Seal Test is designed as a daily Evidence Base Quality Assurance check to confirm that the roller pressure and temperature are operating within the correct operation parameters. The result is a quick visual indication of sealer performance and it incorporates simple documentation.
O11607‐2‐2006 (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