On October 6, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy conducted Session 6 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on HVAC Systems and Qualification in pharmaceutical manufacturing. The event attracted over 200 attendees and continued the PULSE series’ role in providing a platform for industry learning.
The session began with a keynote address by Thiru M. N. Sridhar, Joint Director of Drugs Control cum Controlling Authority, Tamil Nadu (Allopathy, Homeopathy & Approved Drugs). Sridhar discussed the importance of HVAC systems in maintaining optimal conditions for manufacturing, testing, and storage. He emphasised the need for strict control of temperature, humidity, air quality, and pressure to ensure product quality and regulatory compliance. Sridhar also mentioned the support required by MSMEs to implement the Revised Schedule M, urging participants to adopt the standards.
Manish Bhatkar, a subject matter expert in Aseptic Processing and Founder and CEO of RedLotus Pharmtech Private Limited, led the session. Bhatkar highlighted the integration of HVAC systems within the Revised Schedule M compliance framework. He stressed that the new quality objectives place responsibility for product quality on manufacturers. Bhatkar underlined the role of HVAC systems in contamination prevention and the importance of proper architectural design, airlocks, and adherence to the Pharmaceutical Quality System throughout the HVAC lifecycle. He also referenced the WHO guidelines included in the Revised Schedule M.
Bhatkar covered the requirements for sterile dosage manufacturing and the coordination between actuation and architectural design. He discussed air changes per hour and their impact on particulate concentration levels, describing two HVAC system designs: the full fresh air system and the recirculation system. A matrix was introduced to evaluate HVAC components’ impact on environmental conditions such as temperature and air cleanliness. Bhatkar also compared various HVAC systems, assessing them by cost, performance, reliability, and safety.
After the presentation, quizzes were conducted to engage participants and evaluate their understanding of the topics discussed, which saw active participation.
A panel discussion moderated by Harish Jain, President of FOPE, featured industry experts including Bhatkar; T. K. Raghuraman, DGM Quality at Apex Laboratories Pvt. Ltd.; and Dr Sanjit Singh Lamba, Managing Partner at Trillyum Consulting. The panel explored HVAC system design, qualification strategies, and risk-based approaches.
During the Q&A session, panelists addressed questions about pressure dynamics, compliance in production areas, and temperature control. Topics included the management of HVAC systems during shutdowns, power failures, and secondary packaging unit requirements. Dr Lamba advised keeping air handling units running, while Bhatkar recommended operating HVAC systems at lower levels during non-operational hours. Raghuraman suggested calculating HVAC capacity based on area size and product type.
Other discussions included the importance of cleaning return air ducts and the possibility of merging quarantine areas into a single HVAC system. The panelists also covered filtration systems for high dust or volatile environments and filter cleaning frequency based on operational needs.
The session concluded with a vote of thanks by Mr Arjun Kapoor, Additional General Secretary, FOPE, who thanked speakers, panelists, and participants. The next PULSE session on Personal Hygiene, Sanitation, and Contamination Control is scheduled for October 20, 2024.
Supporting associations include Express Pharma as the media partner and Trillyum Consulting as the knowledge partner. Further details and registration are available on PharmaState Academy’s website.
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