ISO Class 7 Cleanroom
Our new, fully certified Class 7 Cleanroom facilitates the injection moulding of a wide variety of complex devices for the medical, pharmaceutical and electronics industries.
Key Plastics utilizes the cleanroom to produce medical grade mouldings compliant to a variety of healthcare standards and approvals including USP Class V1, FDA and more.
The purpose of the Cleanroom is to create a controlled environment that has a low level of pollutants such as dust, airborne microbes, chemical vapours and aerosol particles, thus controlling the level of potential contamination. Key Plastics worked with expert Cleanroom designers to plan and optimise the use of the square footage available – taking into account the processes carried out in the room, the number of team members working in the space and the equipment to be installed within the room.
ISO 7 Clean Room
We chose this class of Cleanroom as it facilitates the needs of our clients manufacturing requirements and it maintains extremely low levels of particulate matter such as dust and airborne organisms – quantified by 10,000 particles per cubic meter. The Class 7 environment is tested to ISO 14644-1 and the HEPA (High Efficiency Penetration Air) filtration rate is over 99% efficient.
Key Plastics is Certified to ISO 13485- Medical Devices
If you are Interested in Clean Room Manufacturing
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