Critical Control For UNICHEM
Unichem Laboratories Ltd. is a global pharmaceutical company that manufactures and markets pharmaceutical formulations and active ingredients. Unichem delivers to customers a blend of modern-day research and nearly six decades of rich experience in the Indian pharmaceuticals industry. The company has manufacturing facilities in Goa, Ghaziabad and Baddi, India.
Challenge
While Unichem has enjoyed four years of successful operations with the Trane chillers at their Ghaziabadfacility, they wanted to optimize 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 11). This was not a simple task as the HVAC system included not only two new 200-ton Trane high-efficiency, water-cooled chillers but also two 40-ton chillers (non-Trane) plus additional air-handling and ventilation units, variable speed drives and Treated Fresh Air (TFA) units. The goal was to achieve maximum efficiency at peak load using the energy-efficient Trane chillers while keeping non-Trane chillers in stand-by mode.
Solution
After considering a number of options, Trane proposed installing a 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 Part11. In addition to HVAC systems, Trane CCS can monitor and control other building devices and subsystems, providing cost savings through a single building automation system.
Results
Trane installed the CCS and completed the project on schedule. 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. A record of temperature and humidity gradient is maintained and monitored by the sophisticated Trane CCS software. The software does not permit any tampering of records, thus ensuring only authentic reports.Mr. Sanjay Kumar, General Manager of Engineering for Unichem Baddi, said, “Trane’s HVAC systems expertise, coupled with the Tracer Summit Critical Control System,provided us solutions in the form of energy efficiency, CFR Part11 compliance and provided close control of required temperature and humidity ensuring the seamless success of this entire critical process.”
About UNICHEM Laboratories Ltd.
Trane’s business in India was established in 1993. Its headquarter of distribution is located in Mumbai, in addition to three sales offices located in Delhi, Bangalore and Chennai.Trane’s primary focus is providing technical support for clients in respect of Integrated Comfort Solutions (ICS) including equipment,controls, services, comprehensive maintenance and facility management solutions and parts.
