Steriking™ Multi-seal Test Kit

The Steriking™ Multi Seal Test kit includes two tests for the operational qualification and testing of the sealing process; the Visual Check Test for seal quality and the Dye Penetration Test for seal integrity. The kit contains components for both tests that are sufficient for one sealing device for about one year depending on the testing frequency. It is recommended that the Visual Check Test is performed daily and that the Dye Penetration Test is used weekly. In sealing process the following quality properties of the seal shall be controlled and evaluated:

• No wrinkles or creases in the seals;
• No material delamination or splitting
• Act seal for a specified seal width
• Channels and open seals
• Punctures or tears

As per ISO 11607:2:2006 there should be a documented process validation program demonstrating the efficacy and reproducibility of all sterilization and packaging processes. Sterile barrier system manufacturing process including the sealing of preformed sterile barrier systems shall be validated. The validation shall include at a minimum, an installation qualification (IQ), an operational qualification (OQ) and a performance qualification (PQ) at this order. Operational qualification (OQ) in sealing process is to obtain and document evidence that the sealer operates within predetermined limits when used in according with its operational procedures. The critical sealing parameters are temperature, time and pressure. These parameters have to be adjusted as per the packaging material sealed.

The Steriking™ Multi Seal Test kit contains components for following tests:

• Seal Seam Integrity Test, ISO 11607-1:2019, Annex B, Detecting Seal Leaks by Dye Penetration ASTM F1929-12
• Steriking™ Seal Control, ISO 11607-2:2019