M + W High Tech Projects LLC

The Customer is implementing a project to build a pharmaceutical plant for the production of sterile medicines in a new site located in the Vorsino Industrial Park in the Kaluga Region.

It is a cutting edge processand has no analogues in Russia and neighboring countries.

The plant includes two production buildings, a separate office building, and a warehouse building.

Process buildings involve the three lines for the manufacture of both standard and cytotoxic medicines. Production lines are located in industrial clean rooms of B, C and D cleanliness class. Several areas with a cleanliness class of up to A are distinguished.

The territory of the enterprise designed for a number of laboratories, such as microbiological, chemical analytical, various test and analytic laboratories.

R-Technologies was a sub-designer under Agreement with General Designer, M+W High Tech Projects. The scope of work included the development of the Heating, Ventilation and Air conditioning chapters (including systems of technological exhaust ventilation, smoke exhaust ventilation, chilled water supply systems, steam distribution system, hot water supply system), building management system (BMS).

Before submitting documentation to Glavgosexpertiza, the project qualification for compliance with GMP (DQ) requirements performed by an external expert organization was successfully passed.

The development of project documentation from the moment of signing the Agreement to the receipt of a positive conclusion byf the FAA Glavgosexpertiza of Russia, taking into account all the necessary intermediate approvals, took only 6 months.