Mecmesin test systems are ideal for testing the physical strength of all kinds of medical devices. Our test software ensures traceable results with full storage of raw data, a robust audit trail, full operator security and guaranteed repeatability.

Whether it is testing the torque integrity of Luer connectors, the glide force of syringes, the physical strength of drug delivery devices, prosthetic joints & bone screws; Mecmesin testers provide you with an easy-to-use and affordable solution.

Our service is backed up by IQ, OQ and PQ document templates to support you in your process validation activities. And we enable you to test to ASTM, BS EN, ISO, DIN, CEN, Ph. Eur. and USP standards.

VectorPro^TM software is designed to help facilitate meeting FDA 21 CFR Part 11 requirements, with its database architecture and strict operator permissions features. For MDR regulations, barcode reader input scans the UDI of a medical device and reports this alongside its test results.

Our products enable you to perform checks to ensure:

• Conformance to standards

• Optimised design

• Efficient production

• Minimum wastage

• Cost savings

• Quality

Find out more about our medical industry test applications in:

• Medical devices and aids
• Connectors and components
• Packaging systems

Quality and reliability is key in a highly regulated environment, where patient safety is critical.

Operational, assembly, removal, and disassembly efforts can all be measured to protect and enhance brand reputation:

• Strength testing of PPE
  
• Integrity of ventilator components
  
• Vaccine delivery device testing
  
• Syringe glide effort
• Syringe pump calibration force
• Biopsy sample gun trigger force
• Drug delivery dial precision torque
• Insulin pen functional performance
• Inhaler disassembly resistance
• Ophthalmic adaptive lens adjustment effort

Mecmesin’s MultiTest equipment securely clamps these medical devices for repeatable tension and compression testing whilst our loadcells accurately measure the wide range of loads involved.

Very small torque values are detected and precise alignment is guaranteed with our Helixa torque testing systems.

For all testers our barcode scanning feature automatically assigns the Unique Device Identifier to the test results for MDR compliant testing.

The physical strength of connectors and key components in medical assemblies can be tested for reliability in use.

Measurement of the efforts to assemble or disassemble a medical device, or test its resistance to breakage, requires suitable test equipment and correct gripping fixtures:

• Luer design taper connector torque
• Tubing pull-out resistance
• Needle strength, bend resistance
• Needle lancet retention
• Stent disassembly resistance

Our range of OmniTest^TM Universal Testing Machines enable the raw materials for packaging, products and components to be accurately characterised in tension and compression, from 2 N right up to 50 kN.

Mecmesin’s VectorPro^TM software is designed to help facilitate meeting the requirements of FDA 21 CFR Part 11, with its database architecture, operator permissions and audit-trail features. Extensometer connectivity and a comprehensive suite of materials testing calculations are included:

• Ultimate tensile strength (UTS)
• Stress and strain at break
• Young’s Modulus
• Yield and 0.2% offset yield
• 3 and 4-point flexural modulus 

If you manufacture or supply primary, secondary or tertiary (transit) packaging, you need accurate and reliable testing systems to follow the stringent standards in force within the industry:

• Openability - peel and tear - of sterile packaging
• Puncture resistance of sharps containers
• Penetration of elastomeric closures
• Actuation force of pump and spray dispensers

Torque testing involves a range of tests designed for threaded closures. This includes measuring the torque to remove or apply the closure and also the measurement of the effort required to overcome critical safety features:

• Child-Resistant Closures (CRC)
• Evaluate push and twist designs
• Breach tamper-evident features

Mecmesin’s versatile motorised testing equipment ensures constant rotational speed control. This is essential for delivering far superior repeatability and accuracy compared to manual torque testers.

A comprehensive range of fixtures hold flexible specimens in a uniform manner without affecting the test results.

Now, more than ever, meeting quality standards are key in the manufacture of personal protective equipment. However, the increased demand for PPE are pushing manufacturers to grow manufacturing capacity and expand some of their product lines at a very rapid rate.

We want to stand with you as you work to meet these demands and help to safeguard the lives of our nurses, carers, doctors, patients and the general public. Mecmesin’ s range of force and materials testing equipment will help you ensure your PPE meets quality-control standards - every single time.

Face Shields are a vital PPE tool being used by front-line workers in the healthcare sector to help prevent the spread of COVID-19.

Bloc Blinds, a leading UK manufacturer of roller blinds, is helping meet the surge in demand for PPE equipment by repurposing production facilities to produce self-assembly face shields. The Bloc FaceShield is a clear lightweight visor fitted with a foam forehead band.

The company wanted to make sure that the peel adhesive properties of the sticky tape were strong enough that the foam would not become detached as the wearer went about their duties, often subject to heat and perspiration.

Read this case study to see how Mecmesin helped them.

• Peel test on visor/face shield foam

• Mask elastic band strength

• Strength of mask connection to headband

• Tear properties of PPE materials

• Peel testing of sterile packaging

Checking the performance and functionality of a syringe is critical with physical testing being high on the list. How much ‘break-loose’ force does it take to initiate movement of the plunger? Once the plunger is moving, does it have a smooth gliding action to safely and consistently inject the drug without causing discomfort to the patient? These characteristics are appropriate to all syringe types; NIS or irrigation, glass or non-rigid, prefilled or refillable. All are subject to international test standards, e.g., ISO 8537, ISO 11040-3 and ISO 11608-3. The test standards clearly define the methods to follow for these tests and manufacturers are looking for simple, cost-effective test systems to help them cope with the extra testing throughput from increased production runs.

Mecmesin offers a stand-alone test system for checking the ‘break-loose’ and ‘glide force’ of an individual syringe. Operators manually load each syringe into the tester, start the test and then unload the syringe when finished. But when the demand is to test hundreds of syringes over various production batches, it really increases efficiency if multiple syringes can be loaded at a time.

A world-leading manufacturer of syringe assemblies approached Mecmesin seeking an affordable automated testing station with the capability to load their ‘irrigation’ syringes in a rotating carousel and then let the testing machine do the rest.

• Recognises where the syringe is positioned and then indexes it to the correct spot.

• Approaches the top of the syringe, ‘touches-on’ lightly and sets a reference point for the test.

• Compresses the plunger rod by a set distance and measures the forces it exerts.

• Records break-loose and glide force results with a Pass/Fail indicator based on the specifications laid down.

This convenient bench-top tester for checking the mechanical properties of a number of syringes, of varying sizes, has enabled the customer to meet the demand of increased production without compromising quality.

Download our latest Syringe & Vial whitepaper for free

In this whitepaper we provide you with an overview of the force and torque testing methods used to assess the quality and performance of syringes – from individual components through to the assembled device.

Also covered is the testing of the sterile medical packaging in which syringes are delivered and testing of the vial from which a syringe must extract and deliver the medication.

Download