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The manufacture of polymer medical devices by MIM, LLC is performed under strict control in Class 6 clean rooms as per ISO 14644
The main production stages are: raw material preparation, polymer injection molding, product assembly, product packaging, sterilization, microbiological testing. Quality control is performed at all stages of the production process. In 2013, the Company implemented a Quality Management System meeting the requirements of GOST R ISO 9001 and GOST ISO 13485
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Raw material
We use only high-quality raw materials from leading Russian manufacturers approved for use in the manufacture of medical devices. All raw materials are subject to thorough incoming control.
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Molding shop
The injection molding of polymer parts is performed on the state-of-the-art injection molding machines by Krauss Maffei (Germany), Haitian (China), JSW (Japan).
For the production of polymer parts, molds made at the factories in Russia, Switzerland, and China are used. The molten plastic, filling the mold under pressure, forms a part of the required design. The types of polymers and the required casting modes are determined by our technical specialists. All molded parts undergo strict quality control.
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The Italian extrusion machine produces all the necessary tubes for suppling with the medical devices manufactured by MIM, LLC. In the extrusion machine, polymer materials are melted and continuously pressed through the forming head, the geometric shape of the output channel of which determines the profile and the size of the resulting tube.
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The production of 3D parts is provided by an extrusion blow molding machine.
The extrusion-blowing machine continuously supplies the material through the forming head in the form of a "stocking". The "stocking" enters an inflation form and the air shapes it as per the contour of this form.
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Assembly and packaging shop
The molded polymer parts after the molding shop are delivered to the assembly and packaging shop. The range of the manufactured products is very diverse, therefore, both automatic and manual assembly of medical devices is performed, depending on the established manufacturing process for each type of product.
The medical devices with high reliability and safety requirements are subject to 100% inspection on special equipment after assembly.
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The packaging of the products is performed in a semi-automatic mode on Formapack and Multivak packaging machines.
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Gas sterilization shop
After packaging, medical devices are delivered to the gas sterilization shop of MIM, LLC. The sterilization is performed with 100% ethylene oxide in accordance with GOST ISO 11135, GOST ISO 11138-2. This method provides for sterilizing almost all types of thermolabile products, causes no metal corrosion, no adverse effects on optics, products made of polymers, plastics. The sterilization is conducted on two gas sterilizers with a total volume of 52 cu m. The shop facilities allow to not only sterilize the MIM, LLC products but also to provide sterilization services to third parties in the amount of up to 750 cu m per month. Upon sterilization, the products are delivered to the quarantine storage warehouse until the results of laboratory tests are received
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Biological testing laboratory
All batches of medical devices are tested for sterility in our own licensed biological testing laboratory. Only after the sterility and non-toxicity are confirmed by the biological test report, the products are transferred to the finished product warehouses of MIM, LLC, for further shipment to the Customers.
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Warehouses
MIM, LLC has iits own equipped warehouse facilities at two production sites – in Tyumen and in the Tyumen region. For the Customers' convenience, the Company also ships finished products from a leased warehouse in the Moscow region.
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