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In order to build competencies of drug inspectors on auditing pharmaceutical utilities like heating, ventilating and air conditioning (HVAC) operations and maintenance, the Gujarat Food and Drug Control Administration (FDCA) recently conducted a workshop themed 'Regulatory approach towards pharmaceutical utilities'.
The workshop is very much relevant as efficient procedures of operation and maintenance are necessary to ensure the efficient working of HVAC equipment and the provision of a healthy environment in pharmaceutical manufacturing units.
Said Gujarat FDCA Commissioner Dr H G Koshia, “Cause of improper operation and unsatisfactory maintenance are generally inadequate training of the technical staff. That is why we are offering training to bridge the gap.”
While Rajendra Patil, senior general manager, engineering, Intas Pharmaceuticals Ltd gave a low down on HVAC Operations, Montu Desai, senior manager, engineering, Intas Pharmaceuticals Ltd spoke on maintenance of HVAC system.
Other speakers, Prakash Prajapati, assistant general manager-QA, Intas Pharmaceuticals Ltd spoke on qualification & validation of HVAC system, Ishit Dave, manager-engineering, Sun Pharma spoke on water systems in pharmaceutical units.
It was deliberated that proper operation and maintenance will ensure reduced utility cost and assist in prolonging the life span of the equipment. Therefore, formulation of strategies regarding operation and maintenance to achieve these objectives is essential.
With the increasing demand within the pharmaceutical industry to reduce both operating costs and environmental impacts, there is a growing recognition of the need to improve the design and operation of the HVAC systems to maximise their operational efficiency.
In line with the current International Society for Pharmaceutical Engineering Good Practice Guide for HVAC, the starting point for optimising the HVAC for any pharmaceutical facility is a thorough assessment of the required environmental conditions. This risk-based assessment should concentrate on the fundamental requirements like air cleanliness, temperature, humidity and recovery rate.
Setting arbitrary limits such as minimum air-change rates should be avoided, as this will tend to constraint the system design. The fundamental requirements should be identified and the air-change rates set to offset the gains in heat, moisture and viable particulate.
Operational Strategies are prepared considering the size and number of buildings, the equipment installed and the amount of funds that can be dedicated for the maintenance of HVAC equipment. A contract may be awarded to companies for these tasks, or, alternatively, the same may be undertaken by technicians hired for these purposes.
The maintenance and operation of HVAC Systems has traditionally been carried out with a focus on complying with statutory requirements for health and safety. Due to short term commercial pressure, the lowest tender price submission from maintenance contractors is often accepted, with little consideration given to long term value for money.
Therefore, opportunities for achieving energy and water efficiency gains are neglected and life cycle costs are not given due consideration.
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