Sai Life Sciences opens new clean room block at its manufacturing campus

Sai Life Sciences, one of India’s fastest growing Contract Research, Development & Manufacturing Organizations (CRDMOs), today announced the opening of a new Clean Room block at its cGMP API & Intermediate Manufacturing campus in Bidar, India.

A notable aspect across all of the company’s infrastructure expansion over the past two years has been to make all new facilities uniformly capable of handling containment down to 1µg/m3. The new 8,500 sq. ft. Clean Room block is the newest addition to this list. Located in the Bidar Manufacturing Campus of the company, it has the following features:

• Four ISO-8 (Class 100,000) Clean Rooms operating at containment level of 1µg/m3 across the operation
• Four parallel crystallizer lines with complete segregation of AHU
• Five versatile dissolution reactors capable of handling various reactions, including if crystallization step is in situ with reaction
• Latest generation Wonderware automation which allows fine ramp control / distillation control to handle critical cooling crystallization and evaporative crystallization
• Versatile sizes of filtration, drying equipment (Filter dryers, Peeler centrifuge, Nauta dryer)
• Various material of construction (SS316, Hastelloy and Glass-lined).
• Separate line for size reduction.
• “Bubble design” with separate gowning / de-gowning areas and airlocks to enable multi-product handling.

Sai Life Sciences began a process of organizational transformation in 2019 reinventing itself as a new generation global CDMO. Through this initiative, named Sai Nxt, the company is investing over US$ 150M (> INR 1000 Cr) to expand and upgrade its R&D and manufacturing facilities, induct top-notch global scientific and leadership talent, strengthen automation and data systems, and above all raise the bar for safety, quality and customer focus.