Manufacturing
Our products are manufactured in our state of the art IVD facility set up over 10,000 square feet in Navi Mumbai, Maharashtra, India. Equipped with clean rooms and separate air handling units (AHUs) for different products (rapid kits, ELISA kits and PCR kits), we ensure there is no cross over contamination. The clean room floors are epoxy coated, use HEPA filters and positive monitored air-pressure to reduce bioburden in the production areas.
We use fully automated coating and production lines from reputed companies like Moduline Systems, USA and Berthold Technologies, Germany.
Our facilities are fully certified and ready equipped for inspection to comply with the new Medical Device Rules (MDR) being implemented in EU.
Our Manufacturing Expertise:
Krishgen Pudgala products are manufactured in our state-of-the-art IVD facility, set up over 10,000 square feet in Navi Mumbai, Maharashtra, India. 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.
Quality Commitment:
We are committed to providing our customers ACCURATE AND RELIABLE IVD TEST KITS THAT GUARANTEE LONGEVITY, SPECIFICITY, SENSITIVITY AND ACCURACY.
Being from the research space for many years, QUALITY is a way of life for us. With our expertise in developing some of the most unique assays worldwide, our IVD ELISA kits have the biggest advantage of being fully validated as per various international guidelines. Regardless of the analyte, each kit embodies our commitment to accurate and precise measurement, designed to maximize quality and ease of use while minimizing variability.
These tests are validated for a high degree of sensitivity, specificity, accuracy and precision against a seven step validation protocol against our SOPs. We ensure that our kits not only operate well during the shelf life but also ensure that stress tests are conducted on each of the individual components to ensure our kits offer stability and reproducibility.
We are as good as our components. THE HEART of each ELISA is the antibodies and antigens. We partner with leading US and European manufacturers to ensure that we get the best reagents. A majority of our ELISA are sandwich formats using double antibodies to offer a high degree of accuracy and monoclonal antibodies for higher specificity and reproducibility.
The use of the best available industry softwares and instruments to support our commitment to quality, with automation and semi-automation being the core of our manufacturing abilities.