What is cleanroom production?
In many cases, an essential condition for manufacturing medical devices and components is for them to be made in a strictly controlled environment, usually known as a cleanroom. Cleanrooms are divided into different cleanliness classes according to ISO standard 14644-1, which concerns the classification of air cleanliness by particle concentration in room air and how this must be measured. Achieving a production environment that meets the standard’s particle concentration requirements places great demands on the quality of rooms, equipment and practices.
Basic conditions include the following:
- Rooms subject to positive pressure and a ventilation system that provides many air changes with highly filtered air.
- Ceilings, walls and floors must be easy to clean.
- Tools such as injection moulders and other equipment must be designed and adapted to shed a minimum of particles and other contaminants while also being easy to clean and maintain.
- Access for personnel and materials only takes place through airlocks.
Producing medical components in a cleanroom also means that such things as inbound materials handling, equipment maintenance, personnel training and quality control of components or products manufactured are subject to GMP procedures and ISO 13485:2016.
AMB’s cleanroom capabilities
In addition to the components intended for medical equipment that are often produced in our regular facilities, we also offer injection moulding, assembly and sterile packaging of single-use medical devices in cleanrooms. We perform assembly and packaging both manually and in highly automated processes, depending on the needs of the project concerned.
Our first cleanroom was completed in 2008 and is validated to class 8, which according to ISO standard 14644-1 means that the number of particles larger than 0.0005 mm must be fewer than 3.5 million per cubic metre of air. Class 8 is the most widely used cleanroom purity level for the production of components and products that must undergo a sterilisation process after assembly and packaging.
During 2018 we completed our second cleanroom, with a total of 1000 m² production floor space in a class 8 cleanroom environment.