Pilot-scale production of Technology Implementation Center is organized in accordance with the GMP EU standard and consists of two main sectors:
- Sector of substances production.
Sector for production of substances is equipped for release and purification of BAS from biological objects (plants, bacteria etc.).
- Sector of ready-to-use pharmaceutical forms production.
Production sector of ready-to-use pharmaceutical forms consists of three blocks (C, B, A): production block of injectable, solid and mild pharmaceutical dosage forms.
To support pilot-scale production Technology Implementation Center has its own laboratories, which allow to conduct quality assessment both of produced samples and raw materials used in manufacturing.
Laboratory of physical chemical analysis methods (LPCAM)
The main task of the laboratory is to determine compliance of raw materials as well as intermediate and finished products with specifications and regulatory documents.
The main objective of the microbiological laboratory is constant control over microbiological cleanliness of production facilities, equipment, cleanroom clothes as well as cultures, raw materials and pre-products used in the manufacturing process.
The laboratory uses LAL-tests to determine apyrogenicity of injectable dosage forms.