As COVID-19 has rapidly spread around the world, there is a concerted global effort to find a vaccine. Millions in international funding is being pledged to vaccine development and to support clinical trials of the most promising prototype drugs.
Vaccines are administered in a number of ways: orally; by subcutaneous (SC), intramuscular (IM) and intradermal (ID) injections and via the intranasal (IN) route. Each of these routes requires the vaccine to be carefully controlled and administered via a medical device. All medical devices have to be tested to ensure they are safe and meet stringent test standards and regulations.
- Software-controlled tensile and compression tester
- Software-controlled precision torque testing system
Appropriate grips for the test being implemented
For SC, IM and ID routes parenteral vaccine delivery is via a sterile needle-based injector with the needle size adapted to the route, age and size of the patient. Vaccine injections are regularly cited as a significant source of procedural pain, especially in children, leading to distress for patients and parents alike. Using force measurement equipment to test syringes by making sure that the plunger moves consistently, without stiction, reduces the chances of any jerky motion associated with inserting the needle painfully into the skin.
Quality-control checking of needle sharpness, by performing puncture-resistance testing, ensures that the needles themselves are all of a consistent standard. Performing axial load and torque tests on Luer connectors to ISO 80369 ensures needles will fit securely into the connectors and not detach.
The fear of needle stick injuries, the risk of disease transmission from needles and the need to dispose of medical waste, has led to the design of alternative delivery devices.
One needle-free approach is the intranasal multi-dose spray pump. It consists of a glass or plastic bottle which is sealed by attaching a nasal spray pump fitted with a dip tube.
The pump is actuated by pressing down the piston, creating pressure which forces liquid through the actuator to generate a spray. A valve mechanism in the metering chamber prevents backflow into the dip tube. Proper mechanical function of spray pumps is obviously critical –that’s why force and torque tests are performed on caps, nozzles, dip tubes and spring assemblies to make sure that they meet stringent quality-control specifications.
In addition to the vaccine delivery device, packaging used to protect the vaccine also has to be tested rigorously for quality control to ensure the packaging provides physical protection for the vaccines and most critically that sterile conditions are maintained up to the point of use.
It is important to understand the design of the packaging components e.g. for vials blowback features, inner neck diameters and stopper designs are important factors to consider to ensure the packaging is fit-for-purpose.
Capping equipment for vial systems play a significant role in ensuring that container closure integrity has been created from the moment the system is sealed off from the rest of the environment. Understanding the compatibility with different aluminum seals and vial systems in relation to the capping equipment can help reduce the risk of a breach in container closure integrity at the very beginning of the sealing process.
Primary vaccine packaging such as sterile containers, bottles, vials and ampoules, especially of live viral vaccines are sometimes stored at very low temperatures or are stored on dry ice during transport, to maintain stability. These storage conditions can impact container closure integrity (CCI) e.g. rubber stoppers lose their elasticity. This loss of elasticity, coupled with inappropriate capping & crimping, can result in increased risk that the packaging seal integrity could be compromised, risking microbial contamination.
Force and torque testing systems are used to carry out a variety of tests on vaccine packaging designs, raw materials and packaging products to ensure the packaging is fit-for-purpose e.g. tensile tests on elastomeric closures; seal integrity, peel and tear properties of flexible, semi flexible and rigid vaccine packaging to test standards such as ISO-11607-1, EN 868-5 and ASTM F88 to ensure it is secure and retains its integrity and sterility but is still easy to open, plus accurate torque measurement to ensure container closure integrity (CCI).
Mecmesin has over 40 years’ experience working with medical device and medical packaging manufacturers to provide the best and most cost-effective test systems to meet their force, materials & torque testing challenges. We understand your industry-specific requirements whether it be IQ/OQ/PQ or FDA 21 CFR Part 11.
- Force, tensile, compression testers
- Torque testers
- Wide range of standard accessories
- Mecmesin can 3D-print custom-fit fixtures for exact matching to component geometry
- Illustration of tests on vaccine delivery devices
- Intuitive software to apply bespoke procedures or international standards
- Interchangeable grips and fixtures enabling multiple tests on one machine
- Pre-programmed test routines for QC checks at point-of-manufacture
- Extensive reporting to log results for audit purposes
Release torque testing of Champagne and sparkling wine corks
The Mecmesin CombiCork is a Quality tool that allows Korbel to test cork materials, ensuring they match with Korbel’s stringent quality standards. Testing removes subjectivity from the uncorking of champagne corks, troubleshooting our process or material variation, so our customers are able to have a consistent experience every time they open a bottle of the finest Korbel California Champagne
Adhesive test on capsulated cork stoppers
A capsulated stopper (T-top, Bar-Top or Altop) is a natural or synthetic cork stopper where the end is glued into a cap of wood, PVC, porcelain, metal, glass or other material. Testing the quality of the adhesive bond between cork and cap is a fundamental check performed by manufacturers of capsulated stoppers and their customers
Vial stopper needle penetrability residual seal force and torque testing
COVID-19 vaccines, as parenteral medications, enter the body by injection through the tissue and circulatory system. Testing the physical properties of these vital drug container systems is a key factor in quality-control testing
Sales of antibacterial gels have soared enormously following National Health Service advice telling the public to thoroughly wash hands in order to stay protected from Coronavirus. In fact, even before the 2020 pandemic crisis, the presence of hand sanitisers had already become commonplace, not only in hospitals but also in schools, restaurants and offices.
In the wake of the Covid-19 lockdown, there have been clear guidelines issued to businesses on keeping staff and customers safe. These include wall signs encouraging people to follow hygiene guidelines through to purpose-made floor tape to help enforce social distancing rules. For successful long-lasting application to surfaces, they all rely on the stickiness provided by the humble self-adhesive.
Break-loose and sustaining force tests of pre-filled drug cartridges to ISO 11608-3
Mechanical pen injectors for delivering drugs, such as insulin, have found increasing acceptance over the traditional vial-and-syringe method. To validate new pen injector designs and maintain quality when they are mass-produced requires extensive testing.
PET preforms - repurposing production for COVID-19 test kits
PET preforms are typically blow-moulded to create the ubiquitous plastic bottles containing carbonated and still beverages. The production process to fill and seal these bottles with a screw-cap is a demanding one, so a number of tests are performed to ensure quality control specifications are met for this core packaging.
Probiotic drink packaging testing
As demand for dietary supplements continues to surge, immune-boosting products, such as prebiotics and probiotics, are amongst the most popular. Getting these liquid probiotic products noticed by the consumer relies on eye-catching innovative packaging which must be easy-to-open and reseal whilst remaining economic to use for the beverage producer.
Testing Ventilator and Breathing Assistance Apparatus Components
A ventilator (respirator) provides ‘mechanical ventilation’ by moving breathable air into and out of the lungs of patients unable to breathe sufficiently well unaided. Such fundamental hospital equipment is essential for all patient care where assisted breathing is necessary.
Face mask strength testing
Manufacturing masks is not as easy as you might imagine. International test standards exist to make sure the face masks can be verified to protect clinicians and patients from pathogens spread by blood, body fluids and secretions and now to limit the spread of COVID-19 coronavirus.
Pharmaceutical tablet crush and break strength
Many products come in tablet form, with a durability designed for both packaging and for use. Too brittle or too hard, and they may not be fit for use, or at best perform below expectation. The only way to determine consistency is mechanical testing of samples.
Lipstick tube force and torque testing
Testing the mechanical performance of the lipstick tube is a crucial part of the quality-control process for cosmetics manufacturers. Leading players in the cosmetics industry have come to rely on Mecmesin’s range of affordable force and torque testers to carry out checks on batches of lipsticks produced.
Mecmesin's materials testers
Testing the physical strength properties of materials, in accordance with international or in-house standards, is a key part of determining their characteristics to better understand the effects of process improvements. With this in mind, Mecmesin has designed a range of static-load Materials Testers powered by intuitive VectorPro MT software.
Top-load crush of plastic bottle with semi-automated test process
To guarantee their containers would perform as expected along customer production lines and remain intact during transportation and storage, US company, Silgan Plastics wanted to undertake top-load tests according to internal, customer and Supplier Packaging Information (SPI) standards.
Dispensing pump assembly testing
Mecmesin's customer manufactures a range of dispensing pumps for the cosmetic and beauty-care industry. A requirement was identified to measure the actuation force of the pump assembly and the pull-off force of the pump handle. The VersaTest motorised test stand was chosen as it gave the necessary repeatability and consistency independent of operator, which a manual stand could not.
Powdered drink container - Mecmesin's compressive strength & lid peel tests
An international supplier of a powdered hot-chocolate drink wanted to test several aspects of their packaging. The client was then able to use their Mecmesin universal tester for all four tests, with quick and easy exchange of fixtures, allowing rapid throughput of samples for testing.
The food packaging industry has long had concerns about pinholes, flex cracks and leaks in the flexible materials and seals of retort flexible lidded packaging. A famous global food and drink maker needed to test the laminated retort (and other thin film) packaging solutions that protect products such as their popular microwaveable stir-in pots.
Battery terminal weld integrity tensile test
BMZ is one the largest European suppliers involved in the design and manufacture of specialist custom made battery systems for mobile power applications. As part of their production process, BMZ Poland in Gliwice needed to test the integrity of the welding on electrical connections fixed to each end of one of their rechargeable cells
Wine cork extraction test to ISO 9727-5
The customer, AMORIM & IRMÃOS, S.A – Unidade Industrial da Valada, required an economic and easy-to-use system to test the extraction force of corks from glass wine bottles. The test specifies a speed of 300 mm/min according to ISO 9727 and the corkscrew should be applied to a depth of minimum 3 mm below the base of the cork.
Nail varnish bottle closure removal torque and capping check
Barry M Cosmetics Ltd is a leading British colour cosmetics brand, offering a comprehensive range of products for face, eyes, lips and nails. The company required a quick, reliable and repeatable test method to check the capping equipment of their nail paint range. Mecmesin supplied a Tornado digital torque tester of 3 N.m capacity, which is a complete, portable, benchtop instrument.
Cosmetic packaging pull-off test
A bench-top testing system was required to repeatably test the pull-off force on a variety of cosmetic containers. The system needed to allow a relatively high volume of containers to be tested with the minimum level of training required for users. Mecmesin's solution avoided the risk of damaging the loadcell by excessive torque on tightening the collet grip, and the lipstick barrel was first inserted in the grip and then connected to the gauge by a flexible chain-link.
Coefficient of friction test
A print factory needed to test the packaging material they were using in order to improve their processes and establish optimum machinery settings. The company sought a solution, which provided consistent results and reliable performance. Mecmesin advised the company to use a coefficient of friction test to determine the 'slip' properties of the packaging.
Closure torque tester validation check
The customer had a number of Tornado closure torque testers, and wished to carry out regular validation checks without the need to return the units to either Mecmesin or an approved laboratory. The closure tester was securely mounted in the vertical plane and a load beam was placed centrally in the universal-clamping fixture.
A system was required to measure the push-on force and removal force of an injection-moulded cap from a new design of oil can. Mecmsin's test was set-up by sliding a can into the lower fixture, while locating a cap, resting on the can's neck, into the self-centering swivel fixture attached to the gauge.
- Jo Webb
- Product Info
- Created 06 Jul 2020
- Modified 04 Aug 2020
- Hits 373