Contract manufacturing of medical devices

Contract manufacturing of large medical products batches has significant advantages over single orders.

The manufacturer's production is carried out on an ongoing basis, which makes it possible to use the available capacity optimally and increase production efficiency by 50% As a result, optimization has a positive effect on the final cost of medical devices and their quality.

In contract manufacturing, the manufacturer reliably ensures all stages of the technological cycle and controls the release in accordance with the established state ISO standards. The concluded contract enables quarterly planning and organization of medical devices production. This cuts the development and product launch time in half.

In general, contract manufacturing allows you to spend more time promoting your product on the market, rather than controlling its manufacture.

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Steps to get your product:

  • coordination of technical specifications, or development of an individual formula for the customer;
  • development of basic documentation for the introduction of the product into production;
  • production of a pilot series;
  • testing of a pilot series in accredited laboratories in Russia;
  • state registration;
  • release of an industrial series.

Our production facilities:

  • area for preparation of solutions, sterile filling and capping. Installed laminar shelters provide 5 class of ISO cleanliness;
  • area for filling and sealing non-sterile solutions into syringes; 
  • sterilization area;
  • area for labeling and packaging of sterile medical devices.

All production facilities are certified and comply with the declared ISO 7 cleanliness class.

Services provided by SigmaLab

The packaging of medical products for sterilization is a necessary step in the production. Sigma Lab implements it in accordance with the norms established by the Law on the Procedure for Registration of Medical Devices.

Filling biopolymer compositions into pre-filled syringes

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The liquid is filled by machine into the following types of syringes:

  • Glass - 1 ml long, 1 ml, 2.25 ml and 3 ml.
  • Cycloolefin - 0.5 ml long, 1 ml long, 0.5 ml and 1 ml.

Automation is designed for filling solutions of different viscosity. The device fills syringes, controls the dosage, and seals. 

Filling in bottles(10R, 6R, 2R)

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The machine automatically sorts and feeds the vials (10R, 6R, 2R), pours the solution into the vials, sorts the stoppers, closes them, removes defective products and displays the finished product.

Freeze drying of thermolabile substances

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After freeze drying, the materials retain their original structure. This is important for both natural and synthetic products.

With this processing method, most proteins do not undergo denaturation and can be stored with moderate refrigeration (about 0 ° C). Tissues and preparations, when moistened or hydrated, almost completely restore their original properties.

Packaging and labeling

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The production process includes packaging and labeling of medical devices. Sigma Lab has its own packaging line, which allows the production of finished products in a rigid blister or outer packaging.

With contract manufacturing in Russia, we guarantee assistance in product development, full compliance with customer requirements and strict adherence to delivery times.

© «Sigma Lab», 2020