Class 8 Clean Room – A reduced bio-burden
Romar’s facilities include an ISO Class 8 clean room, built to manufacture regulated parts for moulding, assembly and packaging.
This state of the art clean room facility maintains an environment that adheres to the ISO 13485 regulations with regard to maintaining a low level of environmental pollutants such as pyrogens, dust, microbes, aerosol particles and chemical vapours.
The bio-burden is reduced – no skin matter and no human touch. Products are packed and sent off for sterilisation.
Due to our continuous dedication to excellence, demand for our clean rooms increased, resulting in our ISO Class 8 clean room being upgraded in late 2013 and again in 2017.
It now houses a total of 12 state of the art injection moulding machines, alongside manual and automated assembly processes to match.
Packaging for Sterilisation
It’s critical to use the right packaging material for your sterilisation process and perform the final packaging in a controlled environment. This ensures the cleanliness and sterility of your finished product.
We have access to validated packaging – and we can custom design and manufacture blister packaging to suit your unique packaging needs.
We find many clients are impressed with how we tailor a thermoformed package to fit their design and sterilisation process, regardless of the complexity.
And – we can also assemble your devices into the thermoform packs, heat seal and label them in preparation for terminal sterilisation.
For more information about manufacturing with Romar or our manufacturing facilities in Australia and South East Asia, contact Romar today.