Quality Inspection for Medical Packaging - VALIDATION TESTS FOR SEALING PROCESSES – Mediwish

DESCRIPTION
Push Indicator Dye Test is especially developed to check the integrity of your seals produced by your heat sealer,
the aluminium package will protect the test ink from light (for Paper and Tyvek packaging). With this ink test you
can easily, safe and quickly, perform an ink test according to the ISO 11607-1 as written in appendix 8. Another
great advantage of Push Indicator Dye Test, is that you can prepare and seal your test pouch in advance, without
the risk of leakage or migration of blue dye onto any objects in your work area.
Push Dye Test MC

What is the Purpose of a Dye Penetration or Dye Leak Test?
Dye penetration testing is used to visually assess potential defects within a sterile barrier system’s seal, most often for medical devices. This test standard is a straightforward methodology that can provide valuable insights into defects in the material or packaging process, particularly validating the seal integrity for medical devices. Most commonly evaluated packaging materials examined with dye leak testing include porous materials such as Tyvek(R) or paper along with non-porous materials such as poly or foil. The test procedure injects a package with sufficient dye solution to generate a depth of 5 mm (0.25 in) along the longest edge of the inner seal. The trained test operator looks for defects and leaks along the seals of the package that may impact the general safety and efficacy of the sterile barrier system (SBS).

• Dye penetrant solution including a surfactant and indicator dye

p T Tester; The first, double check, indicator for the two most critical parameters on your sealing device, namely
temperature and pressure. p T-Tester is a unique dual parameter check for routine and daily monitoring of your
rotary sealer performance, to ensure complete integrity of your sterile barrier system (S as) p T-Tester complies to
the •SO EN 11607-2 requirements.

tester MC 2017
Alternatively;
With the seal seam integrity test from Stericlinn is a simple ink test tool to check these requirem ents. Daily
checking of the seal seams produced by your heat sealer is simply by means of a specially designated testing
solution.

Instructions for Seal Seam Integrity Test MC

What test equipment is needed to perform a dye penetration test?

Testing equipment can vary depending on the test sample and the standard followed. Typical test equipment required for a dye penetrant test include:

• Dye penetrant solution including a surfactant and indicator dye
• Knife or other small apparatus to penetrate part of the packaging system
• A dropper or other dispenser to apply dye
• Ample lightning for inspections

The Stericlinn Seal Test is for the routine testing of your heat sealer. The medical grade paper is imprinted with a
contrast stripe that clearly detects irregularities of the seal seam Available for Tyvek as well.
With both tests from stericlinD it is possible to cover a large part of the testing required for the validation of your
sealing- and packing process according to ISO 11607.
ORDER INFORMATION;
Code Description
Qty

ORDER INFORMATION;
Code
44100
44110
44200
Description
Push Dye Indicator Test for Paper Laminates
Push Dye Indicator Test for Tyvek Laminates
p T tester for pressure and temperature checking heat
804650 Seal Seam Integrity Test Kit – Soln, droppers and beaker.
801990 Seal Test for Paper Laminates
800350 Seal Test for Tyvek Laminates
Qty
30
30
10
250 pcs