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Seal Seam Stability Test
Save €26 on your first seal strength test by the end of the year: The following order form contains all the information you need to carry out the seal strength test for just €85 instead of €111 (net) for new customers!
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FAQ: Sealing seam stability test
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.
Commission us now:
In the following form you will find all the information you need to carry out the seal strength test in your practice for just €80 (net) by the end of the year.
Please fill out the order form and send it together with the sample strips to MELAG. The following instructions will provide you with all the information you need to create the test strips. After successful testing, you will receive a certificate from MELAG confirming the conformity of your sealing seams with the standard DIN EN 868-5, Appendix D.
Sealing seam stability test as a routine test for sealing devices
The seal strength is a decisive factor in the packaging of medical and sterile products. A reliable seal seam stability test ensures that the packaging does not fail under sterilization conditions and during transport, but at the same time is easy to open when it is needed in use.
Why is seal strength important?
The seal seam of medical packaging has two main tasks: It must form a barrier against germs and must not open during storage of sterilized instruments. At the same time, it must be easy to open if necessary so that medical professionals can access the sterile instruments quickly. A defective seal seam could lead to contamination of the sterilized products, which could have serious health consequences.
Standards and test methods
There are various standards for testing the strength of sealed seams, including ASTM F88/F88M and DIN EN 868-5. These standards define the procedures and requirements for testing. For example, ASTM F88 describes the method for determining the force required to open a sealed seam. Samples of the sealed seam are pulled to a certain speed in a pulling machine in order to measure the opening force.
Carrying out the seal seam stability test
The test process involves several steps: Sample preparation: strips are taken from the sealed seam, typically 15 mm wide.
Tensile test: These strips are clamped in the jaws of a tensile machine and pulled apart at a defined speed. The force required is recorded.
Analysis: The results are compared with the specified standards to ensure that the seal seam meets the required standards.
Advantages of regular seal seam testing
Regular seal testing offers numerous benefits that go beyond simple compliance and play an essential role in quality assurance and risk management.
Safety: It ensures that the packaging provides the required protection and that the sterility of the products is maintained during storage.
Compliance: It meets legal requirements and standards, which is particularly important for audits and regulatory authorities.
Quality assurance: It contributes to the continuous improvement of quality management and hygiene processes.
Conclusion
The seal strength is an indispensable part of quality control for medical packaging. The safety and effectiveness of sterile packaging can be ensured by complying with the relevant standards and carrying out regular seal strength tests. Practices and clinics should use reliable service providers to continuously check and improve their packaging processes.
