Advancing Pharma Manufacturing: PULSE Series Focuses on HVAC Systems & Compliance
PharmaState.Academy?
PharmaState.academy? offers easy access to training & up-skilling programs created by experts from Pharma Industry.
We are pleased to report the continued success of the 6th session of PharmaState Academy's PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, held in collaboration with the Federation of Pharma Entrepreneurs (FOPE) . This year-long series, designed to enhance industry expertise on the Revised Schedule M, continues to build momentum as a critical platform for professional development within the pharmaceutical sector.
The latest session, which focused on HVAC Systems & Qualification in pharmaceutical manufacturing, attracted over 200 participants, reaffirming PULSE's reputation as an essential learning resource for industry professionals.
Session Highlights
Chief Guest Address: The event opened with a keynote speech by Thiru M. N. Sridhar, Joint Director of Drugs Control cum Controlling Authority for the State Licensing & Controlling Authority – Tamil Nadu. Thiru M. N. Sridhar highlighted the pivotal role HVAC systems play in ensuring optimal manufacturing, testing, and storage conditions. He emphasized the importance of maintaining precise control over temperature, humidity, air quality, and pressure to uphold product quality and regulatory compliance. He also addressed the support MSMEs will require to adopt the Revised Schedule M, urging participants to embrace these new standards.
Expert Educator Presentation: The session was led by Mr. Manish Bhatkar a veteran in aseptic processing with over three decades of experience and the Founder & CEO of RedLotus Pharmtech Private Limited. Mr. Bhatkar provided deep insights into integrating HVAC systems within the Revised Schedule M compliance framework, stressing manufacturers' accountability for product quality. He discussed the critical role HVAC systems play in preventing contamination, underscoring the importance of proper architectural design, effective airlocks, and consistent adherence to the Pharmaceutical Quality System.
Mr. Bhatkar also explained the relationship between air changes per hour and particulate concentration levels, presenting two key HVAC designs: the full fresh air system and the recirculation system. He introduced evaluation matrices that compared HVAC system performance based on cost, reliability, and safety, providing attendees with actionable knowledge for optimizing their systems.
Interactive quizzes followed the presentation, helping to gauge participant understanding and ensuring full engagement.
Panel Discussion
The panel discussion, moderated by Mr. Harish Jain Manawat , President of FOPE, featured industry leaders:
The panelists shared valuable insights on HVAC system design, qualification strategies, and risk-based approaches, addressing the unique challenges that pharmaceutical manufacturers face.
领英推荐
Engaging Q&A Session
An interactive Q&A session allowed attendees to seek expert guidance on HVAC-related challenges. The panelists discussed various topics, including pressure dynamics in production areas, compliance requirements for secondary packaging units, and aseptic area air sampling. They provided recommendations on maintaining HVAC system readiness during shutdowns and power failures, with Dr. Sanjit advising against shutting off air handling units, and Mr. Bhatkar suggesting reduced operation levels during non-operational periods.
Further discussions covered topics such as the importance of regular cleaning of return air ducts, strategies for integrating quarantine areas into a single HVAC system, and maintaining air quality in polluted environments. The experts also touched on filtration needs for areas with high dust or volatile compounds, and how cleaning frequencies should be adjusted based on operational demands.
Closing Remarks
The session concluded with closing remarks from Mr. Arjun Kapoor , Additional General Secretary of FOPE, who thanked the speakers, panelists, and attendees for their contributions to another successful session.
Looking Ahead
The next session in the PULSE series, focusing on Personal Hygiene, Sanitation & Contamination Control, will be held on October 20, 2024. With a growing demand for practical compliance knowledge, the PULSE initiative continues to be a valuable resource for industry professionals striving for excellence in pharmaceutical manufacturing.
Stay connected for updates on upcoming sessions and ensure your participation in this pivotal learning experience.