Why the manufacture of medical equipment has to be carried out under strict cleanliness conditions

One area of injection moulding we specialise in at Skar is the manufacture of medical components and equipment.

This is a high precision and technically demanding area of work primarily because the manufacturing process has to be conducted to stringent specifications and under strict sterilisation conditions.

Wide range of medical components

We produce a wide range of medical components for use in medical analysis equipment and medical instruments, and regularly advise clients on the design, assembly and packaging of these components in order to reduce cost and cut manufacturing times whilst also ensuring optimum cleanliness.

Clean room facility

Central to our work in this area is our clean room facility, which we are able to create by closing off a designated work area to create an environment with a low level of pollutants.

In this controlled space we are able to restrict the level of potential contaminants such as dust, airborne microbes and aerosol particles. Staff who work in this facility are also fully trained in how to control both airborne particles, as well as microorganisms that must be restricted to prevent the risk of contamination and, ultimately, ensure patient safety.

There are strict guidelines to designating a cleanroom, which must demonstrate a controlled level of contamination, specified by the number of particles per cubic metre at a specified particle size. At Skar our clean room facility has a certified classification of ISO Class 8.

Quality assured

To ensure this level of control is maintained, we also employ stringent quality assurance and monitoring processes, which are built in to every aspect of our work.  Skar is also ISO 9001 and ISO 14001 certified, and our quality management system incorporates full material batch traceability.

With these processes in place, we are able to ensure that, despite the highly technical nature of manufacturing medical components, the client has a seamless experience that results in a quick and cost-effective turnaround without compromising safety guidelines.