Sealing The Quality Of Medical Pouches
Medical device designer and manufacturer, Rocket Medical PLC, is using a Mecmesin computer-controlled test system to perform quality checks on the heat seals of medical pouches in accordance with British Standard BS EN 868-5:1999.
UK (PRWEB) November 5, 2008 -- Medical device designer and manufacturer, Rocket Medical PLC, is using a Mecmesin computer-controlled test system to perform quality checks on the heat seals of medical pouches in accordance with British Standard BS EN 868-5:1999.
Medical Pouch Tensile Test
Rocket Medical PLC produces 1900 product lines, including catheters, syringes, drainage kits and needles used for infertility, cardiothoracic and interventional applications. These medical devices are packaged in pre-purchased pouches, which are heat sealed before undergoing a sterilisation process off-site. As part of British Standard BS EN 868-5:1999 (Packaging materials and systems for medical devices, which are to be sterilised), each pouch heat seal joint must be measured before and after sterilisation to ensure the integrity of the seal.
Rocket Medical PLC wanted to perform this test in-house to save valuable time. They sought a system that could accurately confirm the strength of each heat seal joint was not below 1.5N per 15mm width.
Mecmesin provided an Imperial computer-controlled test system (now superseded by Mecmesin's MultiTest-i range), a 25N loadcell and lever-operated serrated cam grips, which securely holds the sample material throughout the test. Strips of material, 15mm in width, are cut at right angles to the heat seal joint at the mid-point of the pouch. Each end of the strip is clamped into the opposing grips with the tail unsupported. The seal is then tested at a rate of 200mm/min ±10mm/min and the maximum force recorded.
The computer-controlled test system offers Rocket Medical full programming capability, displaying results graphically on a PC screen for easy observational analysis. Both the maximum force achieved per sample and the average maximum force incurred over a number of tests are provided.
David Dixon, Quality Assurance Technician at Rocket Medical comments, "In order to meet the British Standard regarding heat seal strengths on medical pouches, Mecmesin provided an operator-friendly system, which displays data in graphical format to clearly show compliance to the standard."
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