The Importance of a Clean Room for Quality Manufacturing
Central to Romar Engineering’s vast manufacturing capability, which includes medical device manufacturing, elastomers, micromolding and advanced manufacturing, are industry-leading expertise, advanced technology and state-of-the-art facilities.
Here’s what clean room manufacturing involves, and why it’s crucial for first-class manufacturing in highly regulated industries.
About clean room manufacturing
A clean room is a highly controlled and sterilised environment that employs sophisticated High Efficiency Particulate Air (HEPA) or ULPA filtration processes to remove particles, pollutants and contaminants that are 0.3 microns and larger. Clean rooms are widely used in sectors including medical, pharmaceutical and defence that require stringent standards of cleanliness.
The number of particles permitted in a clean room – depending on required function – determines the class of clean room. The International Standards Organisation (ISO) rank clean rooms in ‘classes’ from Class 1 through to 9, and contamination levels are measured in ‘parts-per-cubic-metre’ at work surface height.
Clean rooms employ laminar or turbulent air flow principles to push any contaminants that enter the room directly to vents in the lower portions of the walls, where they are removed or pushed back into a second filtration process.
The Romar clean room
The Romar clean room maintains an environment that adheres to ISO 13485 regulations. It maintains a low level of environmental pollutants such as pyrogens, dust, microbes, aerosol particles and chemical vapours, and reduced bio-burden, with no skin matter or human touch. Our team members are fully qualified and experienced in clean room manufacturing and wear protective clothing to prevent substances from being released into the room.
Romar has consistently stayed at the forefront of manufacturing by being adaptive to new technology and trends. As such, we have upgraded our clean room twice – in 2013 and 2017 – to ensure we continue to provide manufacturing to exceptional standards.
Our clean room houses a total of 12 state-of-the-art-injection molding machines and features both manual and automated assembly processes.
Clean room benefits
At Romar, we utilise our ISO Class 8 clean room to manufacture regulated parts for molding, assembly and packaging.
To ensure the quality of finished products, it’s critical to use the correct packaging material for your sterilisation process and perform the final packaging in a controlled environment. We provide validated packaging and can custom design and manufacture blister packaging for diverse applications. We can also assemble your devices into the thermoform packs then heat seal and label them in preparation for terminal sterilisation.
Our manufacturing capability ensures we provide end-to-end, customising manufacturing solutions that meet all government regulatory and compliance requirements.
Capability for exceptional manufacturing
Romar has been providing first-class manufacturing for decades. Our team of expert engineers and materials specialists work collaboratively across speciality areas including additive manufacturing, medical device manufacturing and elastomers, to provide tailored clients solutions.
Our breadth of expertise, singular technology, including the Lasertec 65 3D printer, and facilities, including our ISO Class 8 clean room, help us provide our robust and scalable manufacturing solutions.
Please contact us if you have a project with strict sterilisation or regulatory requirements.