Rocket Medical PLC are award winning designers and manufacturers of medical devices for a wide range of clinical applications. These medical devices are packed into prepurchased pouches and sealed in-house before being sent offsite for sterilisation. The heat seal on these pouches must conform to British Standard BS EN 868-5:1999 (Packaging materials and systems for medical devices which are to be sterilised). Wishing to perform this test themselves, Rocket Medical sought a test system, which could accurately confirm that the strength of each heat seal joint was not below 1.5N per 15mm width before and after undergoing the sterilisation process.
Mecmesin provided an Imperial 1000 N test system (now superseded by the MultiTest-i range), a 250N loadcell and lever-operated serrated cam grips.To perform the test, 15mm width strips are cut at right angles to the heat seal joint at the mid-point of the pouch. Each end of the strip is then clamped into opposing jaws on the test stand with the tail unsupported. The seal is tested at a rate of 200 mm/min ±10 mm/min and the maximum force recorded. The computer-controlled test system offered Rocket Medical full programming capability. The system displays the maximum force achieved during the test, as well as the average maximum force incurred over a number of tests. This saves the company a significant amount of time when performing tests and provides them with a means of guaranteeing compliance with the relevant standards.
"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."
David Dixon, Quality Assurance Technician
Rocket Medical PLC, UK
