Indian CDMO completes ISO Class 8 cleanroom with "bubble design"

8-Apr-2021

SAI Life Sciences has finished the cleanrooms with separate gowning / de-gowning areas and airlocks to enable multi-product handling

Sai Life Sciences, one of India's fastest growing Contract Research, Development & Manufacturing Organizations (CRDMOs), has opened a new cleanroom block at its cGMP API & intermediate manufacturing campus in Bidar, India.

Making the announcement, Krishna Kanumuri, CEO & Managing Director of Sai Life Sciences said: "Over the last two years we have been seeing an increase in projects involving commercial products, not just for regulatory starting materials and intermediates, but also final drug substances. This addition of latest generation clean rooms to our facilities expands our capacity while adding versatility to help serve the diverse needs of our customers."

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 1 µg/m³. The new 8,500 sqft cleanroom 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) cleanrooms operating at containment level of 1 µg/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.

Companies

• SAI Life Sciences