Testing the Tensile Strength of Heat Sealed Medical Pouches

Specification

Award winning medical device designers and manufacturers, Rocket Medical PLC, produce a large variety products for clinical applications, which are packaged in pre-produced pouches, sealed in their manufacturing plant and then sent for sterilization.

Systems and packing materials for medical devices that will be sterilized, must be produced with heat seals that conform to BS EN 868-5:1999. The heat seals on Rocket Medical PLC’s pouches also had to conform to this standard.

Rocket Medical, wanted to bring this test in-house, so looked for a test system which could be used to accurately check that the strength of every heat seal joint before and after sterilization didn’t fall below 1.5 M per 15 mm.

Solution

Medical pouch peel test

An Imperial 1000N test system was supplied by Mecmesin (which the OmniTest range has now replaced), along with lever-operated serrated cam grips and a 250N loadcell.

The test procedure consists of cutting 15 mm width strips at right angles to the heat seal joint, which is at the mid-point of the pouch. The test stand’s opposing jaws are then clamped to each end of the strip, with an unsupported tail; a T-peel test.

Rocket Medical PLC, had full programming capacity due to the computer-controlled test system. The maximum force of the seal is recorded with the testing rate set at 200 mm/min ±10 mm/min.

The system shows the average maximum force achieved over a number of tests as well as the maximum force of the current test. Compliance with relevant standards is guaranteed, while also being a significant time-saving measure.

System

  • Lever-operated cam grips (serrated)
  • Loadcell 250N
  • Imperial 1000N (now superseded by the MultiTest 1-i)” to “Imperial 1000N (Superseded by the OmniTest 1 universal testing machine)

Testimonial

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

About Mecmesin

Established in 1977, Mecmesin is a global brand renowned worldwide for delivering reliable, affordable and innovative force, materials, and torque testing equipment for quality control. 

Mecmesin is part of the Physical Properties Testers Group (PPT Group), a multi-national group of brands expert in the design and production of solutions for testing a range of physical properties including compression, light fastness, moisture, dry rate, water repellency, abrasion, flammability, texture, tensile and torque properties.

The PPT Group has regional offices in the UK, France, Germany, the USA, Thailand and China.  The Mecmesin brand is also supported by a global network of distributors in more than 50 countries able to provide technical expertise and after-sales support to customers locally.

The focus of the brand has always been to provide high-quality test solutions, which are an affordable alternative to the many higher-priced systems available, enabling small and large businesses alike to undertake quality control checks on their products without compromising on precision and accuracy.

The rugged design of these systems means they can withstand tough factory conditions and perform tests at the point of production rather than having to use expensive laboratories to ensure consistent manufacture.


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Last updated: Dec 13, 2023 at 12:46 AM

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