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Medplast

Medplast

“Medplast” LLC has been producing medical devices since 2001.
At the present time it produces up to 500 000 pcs. of blood
transfusion systems (BTS) and solution infusion systems (SIS).
– It has its own administrative and production two-storey building with a total area of 1082.2 square meters, and other buildings.
– Land area of 0.5492 ha.
Manufacture consists of:
– Plastic molding shop floor (premises of cleanliness “D” class).
– Product assembly shop floor (premises of cleanliness “C” class). Product assembly shop floor has 70 sets for workers.
– Site of secondary raw materials recycling.
– Mechanical site with small machine-tool park, laundry.
– Whorehouses of raw materials, constituent parts and materials – 270
square meters.
– Whorehouse of ready-made products – 50 square meters.
– Indoor parking space.
There is a following equipment at the plastic molding shop floor:
– Injection-molding machine – 4 pcs.
– Extrusion line – 2 pcs.
– Vertical hydro-extrusion machine – 2 pcs.
There is a following equipment at the site of secondary plastic recycling:
– Chipping machine – 2 pcs.
Quality Control.
At each site of manufacture a multi-stage quality control is
implemented.
– Control of raw materials.
– Control of manufacturing process of semi-finished products in molding
shop floor.
– Control of product assembly manufacturing.
– Quality control of ready-made product and its check-out for
toxicity, pyrogenicity and sterility.

Products of “Medplast” LLC corresponds to Technical Conditions of
Ukr Sepro, has registered at the Ministry of Health of Ukraine.
As of today an enterprise prepares technical documentation, completes
the reconstruction of the premises for receiving the Compliance
Certificate and transition to quality system ISO 13485:2005.
The plans for 2017 are to obtain the CE quality certificate.

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