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Clean Room Manufacturing

PLITEK® offers die cutting services in state-of-the-art ISO Class 8 (100,000) clean rooms available for every step of the manufacturing process. Materials and parts can be produced, inspected and packaged in the clean rooms to ensure parts are free of foreign particles, DNA and RNA contamination that could impact product integrity.

Clean Room Production Environment

A clean room is designed and constructed to control the concentration quantity of airborne particles. The room is operated in a manner to control the introduction, generation, and retention of particles inside the room.

If adhesives and flexible materials are exposed to pollutants, they can be contaminated which impacts the product. ISO qualified clean rooms have a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. ISO Class 8 clean rooms, also known as Class 100,000 clean rooms, have a maximum particle count of 3,520,000 0.5um particles per cubic meter (124,307,627 0.5um particles per cubic foot) of interior air.  The air outside in a typical urban environment contains 35,000,000 particles per cubic meter with a size of 0.5 micron and larger in diameter.

The air in a clean room is filtered by several outdoor air filters (HEPA and/or ULPA) using progressively finer filters to exclude dust and particles.

Clean rooms are used in practically every industry where small particles can adversely affect the manufacturing process. A few of the high-demand markets such as medical devices, pharmaceuticals, electronics, and others benefit from the tight control of air quality provided by our clean rooms. PLITEK® manufactures products under the requirements of Quality Management System (QMS) following the strict protocols.

ISO Class 8 environmentally controlled clean rooms are available for every step of the manufacturing process:

Clean Room Manufacturing
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PLITEK® is an ISO 9001:2015 and ISO 13485:2016 certified global converting leader.