Krishgen Group is proud to announce the inauguration of our new manufacturing facility in Bhiwandi – just outside of Mumbai.

Krishgen ELISA products will now be manufactured in our state-of-the-art IVD facility, set up over 10,000 square feet. Equipped with ISO Class 7 / 8 clean rooms and separate air handling units (AHUs) for different products (rapid kits, ELISA kits and PCR kits), we ensure there is no cross-contamination.

The clean room floors are epoxy coated and use HEPA filters and positive monitored air-pressure to reduce bioburden in the production areas. Fully automated coating and production lines from reputed companies like Moduline Systems, USA and Berthold Technologies, Germany ensure high precision, and low variation. Our labs also have other semi-automated or completely automated processes with stringent SOP to ensure that product quality is maintained to required ISO standards. Aside from spacious production facilities, R&D and QC laboratories, we also have large warehousing spaces that store both raw materials and finished goods at various temperatures.

Our facilities are fully certified and ready equipped for inspection to comply with the new Medical Device Rules (MDR) being implemented in the EU.

This new manufacturing facility also allows us to expand our production capabilities and reduce our delivery timelines.