Sponsored by Mecmesin
Mecmesin designs and manufactures force and torque test systems that are accurate, reliable and excellent value for money.
We understand that the physical testing of medical device products and materials ensures regulatory compliance and protects your brand reputation. Leading names in the medical sector rely on Mecmesin’s innovative testing solutions.
Who is Mecmesin?
Mecmesin is a global brand, with over 45 years experience in the design of reliable force, materials and torque testing solutions for quality control, ensuring customers around the world can achieve consistent and accurate test results, every time.
As part of the PPT Group, Mecmesin operates under strict ISO 9001 quality standards and Mecmesin products are used to guarantee the quality of components, materials and finished products for an extensive range of test applications within the medical device industry. Equipment is ideally suited for use in R&D, the QC laboratory and on the factory floor.
Though headquartered in the UK, 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.
What is unique about Mecmesin?
We work with our customers to find the best testing solution for their application, budget and changing needs. Whether that takes the form of a handheld gauge or comprehensive computer-controlled system. Mecmesin supplies gripping fixtures and a range of dedicated testers, all designed to test to recognised international and industry standards. Our engineers can also design and manufacture bespoke solutions to meet your own unique criteria.
What are the customer benefits of performing these types of tests?
Gaining an in-house capability for quality assurance, rather than outsourcing, is a major cost and time reduction benefit we see for many customers. Medical devices are often assemblies comprised of a number of individual components. Should a seal be out of alignment, the device may not function correctly and maintain its performance. Our instruments can display an instant, pass/fail indication against defined criteria, immediately flagging a potential problem with a source of supply.
Our touch screen and computer-controlled systems display the test graphically, which gives valuable insight into the performance of the individual sample and the ability to quickly compare against samples from other batches.
How are your solutions suited to the medical sector?
Our VectorPro software was developed in collaboration with our customers within the medical industry to assist them in meeting the requirements of FDA 21 CFR Part 11.
Key features of the software include:
Intuitive icon-driven interface and workspace
Advanced 'drag and drop' test routine builder
Personalised user accounts and favourites
Touch screen enabled
Stress/strain machine control
Active load control (load holding & load ramping)
System deflection compensation
Manage user permissions and audit trail
Built-in materials testing calculations
Customisable test report templates
Print and e-mail reports in Adobe PDF format
Export data to Excel and other analysis packages
Can you give an example of the kinds of tests Mecmesin equipment can perform on a widely-used device?
Established international standards for medical devices make sure that they are functional under correct usage conditions and resistant to failure and inadvertent disassembly.
Several of our customers have implemented a range of tests applicable to syringe usage. The glide force of the plunger/cylinder assembly is a fundamental factor in the basic operation of the device.
Correct alignment of the compression axis is necessary for accurate measurement and our special engineering department has often made bespoke fixtures to hold syringes of varying bore diameter. Assembly of needles and connectors into the syringe requires versatile torque testing equipment to precisely measure low torque values whilst ensuring exact axial alignment of the rotating parts.
Our Helixa system is designed to meet this requirement and is able to perform checks on the industry-standard Luer connector. Another of our customers calibrates their syringe pump equipment by using a Mecmesin instrument to set the ‘occlusion pressure’ (a trigger force to detect a blockage),
What checks can ensure even the most innovative medical devices are reliable?
Instruments for drug delivery have mechanisms which must be secure yet easy to activate. This may be the effort required to rotate a dial to set a dosage or pull a trigger to inject. Our systems can measure the important parameters which define the desired functionality and enable even the most complex ground-breaking designs to be efficiently developed for intended purpose and thoroughly tested for continuous use.
What are the challenges in testing medical packaging?
For medical packaging, maintaining sterility and security is essential but the seal must not be so strong that it is difficult to open. Manufacturers and their clients must test the seal strength, tear and puncture resistance of packaging.
To accurately evaluate openability, peel testing equipment must be able to hold the flexible or semi-rigid container without deformation. It also needs to secure the surface layer, which provides a breathable microbial barrier.
Mecmesin also has a wealth of expertise in testing the application and removal torque of tamper-evident, Child-Resistant Closures (CRC). The requirement to apply an axial force and torque simultaneously is met by our Vortex motorised test system. This allows testing at a constant speed as stipulated in the latest closure testing standards. To maximise repeatability gripping the closure uniformly is assured by a custom mandrel to your specific closure design.
Could you summarise Mecmesin’s unique offering for a medical technology brand?
With our range of force and torque testing equipment and, if needed, our custom design service, Mecmesin can supply you with a versatile system to test your medical product, its packaging and even assist in its calibration.