FEATURE PLASTICS & INJECTION MOULDING


How cleanroom thermoforming can create ideal packaging for medical devices


the most stringent regulations from various organisations. One of them is The ISO (International


Organisation for Standardization) which consists of a group of non-governmental bodies operating in 164 countries. It is entrusted with the power to enforce exacting standards for a range of commercial markets. In 2016 it published the latest edition


of its ISO 13485 which sets out to ensure patient safety by the regulation of hygiene and contamination control in medical product development. It is generally recognised that the


By Todd McDonald, director of sales & marketing at TEQ


T


he world continues to marvel at amazing developments in


technological brilliance but what must not be overlooked is that the importance of protecting that technology becomes increasingly crucial. Improvements to packaging design are


now a necessity. At the same time, there is a demand to deliver products in a packaging solution that adheres to strict specifications while using less production energy and material as well as faster production times. Cleanroom thermoforming is widely


used for the production and packaging of pharmaceuticals and medical equipment. This method of thermoforming is carried out in an ISO certified cleanroom meaning any particulates circulating in the air are kept to a minimum. Thermoform packaging is extensively


used to safeguard sterile instruments and implants. This packaging method permits the use of lightweight, clear plastic enclosures that stop microbial and dust particles from contaminating the sterile item. They also make possible the product’s secure storage for lengthy periods whilst maintaining the sterile environment. This advanced technology has


established itself as a preferred option for many industries and applications, including medical devices, with the main benefit of this packaging solution the


16 DECEMBER/JANUARY 2021 | IRISH MANUFACTURING


clear cost efficiency it offers. The stiffness of this type of packaging material also allows for the creation of smaller units and space-saving benefits. The stiff packaging also offers a barrier to odours and resistance to oil and grease. Packaging from cleanroom


thermoforming also has the capacity to offer advanced protection of medical devices and the importance of this cannot be underestimated as the packaging of medical devices is as important as the product itself. Once the packaging’s integrity is compromised, sterility is lost and the device is ruined. This is why thermoforming is an ideal solution.


CLEANROOMS THRIVE DURING COVID-19 PANDEMIC There are clear signs that the COVID-19 Pandemic is having a significant impact on the design and manufacture of medical devices, equipment and implants. In these uncertain times medical


manufacturers have had to ramp up production to meet heightened customer demand. Cleanrooms have firmly established themselves as an integral part of the production process as cleanliness can be guaranteed in their controlled and sterile environment, preventing potential contamination caused by bacteria or air pollutants. Companies that make medical devices and the packaging for them have to meet


Above: Todd McDonald, director of sales & marketing at TEQ


main hurdle to overcome when designing cleanrooms is their ability to deal with any air pollutants. Filtration units are used by manufacturers to control airflow and stop airborne particles larger than a pre-defined size from entering. A range of devices can make this happen such as ionisers, carbon filters and non-filter purifiers. Another approach to preventing cleanroom contamination is by providing a high standard of training for staff and ensuring they wear correct PPE such as gowns, hairnets and overshoes. Manufacturers are also advised to keep


correct supplies and equipment in clean spaces and, where appropriate, dispose of or sterilise them. Regular risk assessments ensure ongoing improvements can be made to foil any new contamination threats triggered by ever evolving technologies. One thing is for certain, continued


innovation and the advance in technology in the medical sector brings with it unlimited potential. Manufacturers will face the same


pressures to cut costs and be even more efficient by introducing more automation on the assembly line, utilising the likes of robots and smart testing. AI and machine learning can also expect to play a role by boosting quality standards and early detection of any issues. New developments and a move towards


more complicated products such as nanotechnologies and the miniaturisation of devices are another new challenge that has to be faced by manufacturers in an increasingly competitive sector.


TEQ www.teqnow.eu


/ IRISHMANUFACTURING


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