Laboratory research

Since 1999, the production of medical devices has required compliance with the standards specified in the legislation of the Russian Federation.

The Law on the Procedure for Registration of Medical Devices requires that any pharmaceutical product has a laboratory test report. It can only be provided by testing laboratories accredited to class 42 of the MKTU, and Sigma Lab cooperates only with such laboratories.

Health and often life of a person depends on the quality and safety of medical equipment, therefore, our company takes care of its customers and strives to create products of the highest quality. All products are tested in independent laboratories with advanced medical technologies.


Laboratory research in the framework of production control

Laboratory research as part of production control is carried out throughout its entire cycle - both before the start of the release of each batch of products, and during its creation.

Sigma Lab also conducts internal tests to ensure the sterility and safety of the manufactured product. All test methods are in accordance with ISO standards for laboratories.  

External quality control of laboratory research

External quality control of laboratory research takes place in cooperation with 6 reference laboratories. The results undergo a three-stage statistical processing in accordance with the norms of the Federal System for External Quality Assessment.

Laboratory research

Quality control takes place at all stages of production. Incoming raw materials are checked for the following indicators:

  • the level of bacterial endotoxins;
  • level of bioburden;
  • undergoes intermediate control of the pH level of the solution and its viscosity;
  • the final product is tested for sterility and undergoes tightness control.

© «Sigma Lab», 2021