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The seal strength test, which checks the strength and integrity of the seal of sterilization packaging, is an essential part of quality assurance in medical facilities. This test must be carried out in accordance with ASTM F88/F88M and DIN EN 868-5. This international standard specifies the requirements for materials, sterile barrier systems and packaging systems used to sterilize medical devices. It describes the methods for determining the seal strength and ensures that the packaging provides a sufficient barrier to ensure the sterility of the contained products until the time of use. Compliance with this standard is critical to ensure the safety and effectiveness of sterilization procedures and to minimize the risk of contamination.
This test procedure ensures that the seals are strong enough to maintain the sterility of the packaged instruments until they are used. In order to continuously meet the highest standards of hygiene and safety, the seal strength test should be carried out at least once a year. The annual inspection ensures that the seal seams meet the current requirements and that there is no compromise in the sterility of the medical products. Regular testing is therefore essential for effective quality management and contributes significantly to patient safety.
Yes, MELAG offers independent and certified seal strength tests for products from all manufacturers. This includes sealing devices and films from brands such as Euronda, Dürr and Henry Schein. MELAG ensures that the seal seams meet the highest quality and safety standards, regardless of the brand of equipment used. This allows facilities to ensure that their sterilization packaging is reliable and compliant with applicable standards, contributing to overall patient safety and hygiene.
