How IS Mecmesin testing to perfection in the Medical Device industry?
Mecmesin designs and manufactures force and torque test systems that are accurate, reliable and excellent value for money. Physical testing of medical device products and materials ensures regulatory compliance and protection of brand reputation. Leading names in the medical sector are testing to perfection with Mecmesin.
Achieving compliance with local requirements can be a tough deal and an unexpected challenge sometimes
Who is Mecmesin?
Mecmesin is UK-headquartered, with subsidiary companies in Europe, USA and Asia, plus a worldwide distributor network. We operate under ISO 9001 quality standards, and for over 40 years our test equipment has been used to guarantee the quality of finished products and materials across many diverse industries. Equipment is ideally suited for use in R&D, the QC laboratory and on the factory floor.
What is unique about Mecmesin?
We offer simple hand-held instruments to fully-comprehensive computer-controlled systems to suit many test applications, budgets and changing needs. 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?
We provide complete testing solutions. Whether it be based on a standard, versatile tester or on a dedicated system targeted to a specific quality control requirement, Mecmesin works with you to deliver a setup that meets your individual needs.
Our equipment is designed for customers in the Medical and Pharmaceutical sectors and when required we can assist you with Installation, Operational and Performance Qualification protocols (IQ/OQ/PQ).
Our VectorProTM software was developed in collaboration with our customers within the medical industry. It incorporates operator permissions security, audit trail features and database architecture to support FDA 21 CFR Part 11 compliance environments. Our latest feature allows the use of barcode readers to quickly scan the UDI of a medical device and report this alongside its test results.
In a highly regulated industry, safety-driven compliance impacts all areas of the supply chain. Standards bodies such as the European Pharmacopoeia (Ph. Eur.), US Pharmacopoeia (USP), ASTM, ISO, EN and FDA have individual test standards cover everything from packaging, drug delivery devices to medical product design and formulation. Our customers appreciate the versatility of Mecmesin equipment to test in accordance with these standards.
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.
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