Todd McDonald, director of sales & marketing at TEQ, explains why there has been an increased demand for cleanroom use during the COVID-19 pandemic.
TEQ
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 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 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.
