Trane Helps Unichem Achieve FDA Compliance

Unichem Laboratories is a well-known name in the pharmaceutical industry, with a dominant presence in several countries. The company manufactures and markets pharmaceutical formulations and active ingredients. It has nearly six decades of experience in the Indian pharmaceutical industry. The company has three manufacturing facilities at Goa, Ghaziabad and Baddi in India.

Unichem recently deployed cooling solutions from Trane at its Baddi manufacturing facility in Himachal Pradesh.

Interlinking growing business units

With the growing business at Unichem Laboratories, the company is handling more than one product at one unit. It is also mandatory for the company to follow United States FDA compliance as it is operating in several countries outside India. Unichem wanted to optimise the heating, ventilation and air conditioning system (HVAC) to deliver maximum energy efficiency and reliability, and achieve full United States FDA compliance (21 CFR, Part II).

“Earlier one particular unit was handling one product at a time. Now we have 63 units and each unit is handling more than one product at a time. Interlinking of these units was a tough job poised before Unichem. Interlinking of units will reduce the processing time. Our goal is to achieve maximum efficiency at peak load using the energy-efficient chilling solutions while keeping other chillers in stand-by mode,” observes Sanjay Kumar, GM, Unichem Laboratories, Baddi.

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Cooling the units through Trane

Due to Unichem’s previous experience in using Trane at their manufacturing facility in Ghaziabad, the company decided to go with it even for their Baddi facility. After considering a number of options, Trane proposed installing a Tracer Summit Critical Control System environmental control. The Trane CCS software maintains and monitors a record of temperature and humidity gradient. The software does not permit any tampering of records, thus ensuring only authentic reports.

The Baddi facility has deployed two Trane Water Cooled Screw chillers of 200 tons each and Trane Tracer Summit Critical Control System (CCS) to provide complete environmental management for all FDA-regulated areas, including research and distribution. This FDA compliant control system features extensive documentation and reporting capabilities to meet FDA 21 CFR Part II.

Seamless success

Along with HVAC systems, Trane software is monitoring and controlling other building devices and subsystems by providing cost savings through a single building automation system. In the manufacturing area, all processing rooms have their own dedicated air handling system to prevent cross contamination. Each processing area has total environmental control.

“Trane chiller solutions are connected with other warehouse solutions and are also compatible with other systems running at our plant. The implementation has helped us in the management of overall environment and now we can handle the crisis,” reflects Kumar.

With the interlinking of the processes, the time taken for the whole process has also decreased. The plant has also been able to seamlessly overcome the problems attached to the critical processes. Trane has been able to provide the plant with the highest level of performance with lowest emissions of refrigerants. Now the Trane chillers along with others are able to take the load during the peak periods.