CAT Moscow qualifies clean rooms for Russian COVID-19 vaccine production

COVID-19 Vaccine Production at Binnopharm (Copyright Sistema)

COVID-19 Vaccine Production at Binnopharm (Copyright Sistema)

The Moscow region, where the Stuttgart cleanroom specialists CAT Clean Air Technology GmbH has been represented for ten years with an independent company, is becoming the center of Russian COVID-19 vaccine production. Currently, mass production of the vaccine "Sputnik V" is being prepared – among other things, at the production site of the Russian pharmaceutical company JSC Binnopharm in Zelenograd, north of Moscow. CAT Moscow is responsible for the complete installation and functional qualification of the required cleanrooms and HVAC systems.

The CAT team, which conducts cleanroom testing at Binnopharm, consists of ten experts. They will ensure that the installed cleanroom systems in Zelenograd meet international normative and user-specific quality requirements and are commissioned. The scope of the project includes both installation qualification (IQ) immediately after the setup of the system and operational qualification (OQ) during ongoing operation. The project start is now in November 2020.

The Russian COVID-19 vaccine "Sputnik V" was developed by the Gamaleja National Center of Epidemiology and Microbiology. The research institution has successfully brought vaccines against Ebola, MERS, and influenza viruses to approval in recent years. Mass production of "Sputnik V" is now to take place, among other locations, at Binnopharm in Moscow on a several hundred square meter cleanroom area.

CAT Clean Air Technology GmbH, headquartered in Stuttgart-Weilimdorf, has been active on the Russian market for ten years with an independent company. The portfolio includes, in addition to cleanroom qualifications like the current project at Binnopharm, validations according to GMP and ISO standards, commissioning, and the sale of cleanroom products.