Dissolution Quality Control at Zydus Cadila Healthcare


​​​​​​​​​​​​Testimonial by, Sohil Dudhia, Associate Manager, Exhibit Stability Lab, Cadila Healthcare Limited, PTC, Moraiya-Ahmedabad, India

“We had several problems with our previous system from another manufacturer, including: vessel-to-vessel temperature variations, sampling volume problems, PVT (performance verification test) failures and vessel-to-vessel reproducibility issues. These were major quality control challenges affecting OOS (out-of-specification) results and CAPA (corrective and preventive actions). The Teledyne Hanson Elite 8 Dissolution Tester integrated with their Vision AutoPlus Autosampler resolved all problems, with excellent reproducible results, and greatly reduced number of CAPA investigations.

“We have found Teledyne Hanson instruments to be high quality, rugged, and reliable, as well as meeting and exceeding USP and ASTM requirements. After the Teledyne Hanson dissolution purchases, the breakdown frequency including several dozen testers has come down to virtually zero. We have had no breakdowns in the last four years, which has maximized our utilization of the instruments. We would highly recommend Teledyne Hanson’s Elite 8 tester with AutoPlus autosamplers as they are easy to operate, there are no sampling or temperature issues and they are 21CFR Part 11 Compliant.”

Cadila Healthcare Limited aka Zydus Cadila is a multinational pharmaceutical company headquartered in Ahmedabad, Gujarat, primarily engaged in the manufacturing of generic drugs.