Kemei’s 100,000-class clean room is the right manufacturing environment designed to easily build quality medical devices as per follow GMP requirements. Applied in the manufacturing of medical products, our clean room’s status is determined by the maximum amount of particles present per cubic meter of air. What this entails is that our gloves are carefully laundered, dried, tested and packaged with minimal human intervention to meet a particle count compatible with the clean room and thus prevent contaimination.
Specialized equipment maintains the cleanliness of the dust-free facility, from the use of epoxy resin on floors to smart temperature control. We use a positive pressure filtered air system to control the entry and exit of particles in the area to maintain cleanliness. Further, we sterilize and fumigate the room regularly to ensure that production is carried out under low bio-burden levels.
To prevent contamination, we use the latest packing machines to handle the automatic walletting, pouching, and sealing of our gloves and without the need for human intervention. Pouching machines make use of aesthetic packing methods that use skip sealing to contain gloves while printing out manufacturing details on the pouches.
Every step of the process is done in a controlled environment and without contamination, thus leading to very little chance of contamination and a great degree of hygiene.
With Bio Monitors overseeing the process cycles, our high-end E.T.O sterilization plants check our products and packing material to ensure they are suited for E.O. sterilization. At the same time, we guarantee that sterilized products maintain their long shelf life and cleanliness while being stored. Validated to EN 550 Norms, our sterilization plants come with a double door system for efficient containment.
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