Pharma Industrial India Magazine - May-June 2024

which is less energy-efficient and requires extensive pro - cess monitoring. Our Orion™ cold WFI solution addresses these challenges effectively. Additionally, we offer solutions for treating complex effluents, such as our EVALED™ sys - tem, which includes mechanical vapor recompression-based evaporation technologies, offering lowest OPEX, minimizing environmental impact while maximizing water recycling and byproduct recovery. Q Could you elaborate on Veolia’s manufacturing opera- tions, particularly in India? Gopalakrishna Madabhushi: Most of our products are manu- factured outside India, but we do have a factory in Bangalore where we produce NF & RO membranes. While the majority of manufacturing occurs abroad, we strategically manufacture certain components in India to cater to local demand. Q What are the benefits of bioburden testing and rapid mi - crobiology methods in quality control? Gopalakrishna Madabhushi: Traditionally the bioburden testing takes 5 days and this adversely impacts the produc- tivity and well as decision-making at the quality control lev- els. Our Rapid Microbiological Monitoring platform (Sievers™ Soleil) gives results in just 45 minutes (or less) and it is the only rapid platform where the results are co-relatable to the traditional measurement method (plate count) Q How does Veolia ensure compliance with varying quality standards across different countries? Gopalakrishna Madabhushi: We adhere to world-class standards in all our products and services, recognizing that global standards are evolving. While we maintain high-quality standards universally, we engage with customers in regions with relaxed standards to ensure our solutions meet their spe- cific requirements. Our analytical instruments, for instance, comply with stringent international standards, regardless of local variations. Q What is the significance of real-time release testing (RTRT) in pharmaceutical water monitoring and the role of data integrity in process analytical technologies (PAT) and real-time release testing? Gopalakrishna Madabhushi: Unnecessary delays during pharmaceutical water monitoring have negative impacts on productivity and the ability to efficiently supply patients with the drug products they need. Real-time release testing (RTRT) of pharmaceutical water exponentially enhances pro- cess efficiencies by migrating from laboratory-based checks like that of total organic carbon (TOC) and conductivity mon- itoring in accordance with USP <643> and USP <645> re- spectively to online-based monitoring and release of Water for Injection (WFI)/Ultrapure Water (UPW) into production. In doing so, eliminates the need to isolate and evaluate WFI/ UPW grab samples in the lab frequently, streamlining the pro- cess by which water is released into production. Data Integrity is the heart of decision-making in PAT and Real Time Release Testing and as all decisions are taken based on the data points generated during monitoring and measure- ment, it is eminent that the data is not only accurate but is also reliable and has not been tampered with. This is where data integrity becomes so very important and that brings in various checks like 21 CFR Part 11, which is a check to make sure anything and everything that has happened has been accounted for and there is someone who is tagged for that change. Q What strategies is Veolia employing to expand its pres- ence in Asia, particularly in the pharmaceutical sector? Gopalakrishna Madabhushi: In Asia, our focus is on provid- ing fully integrated solutions tailored to meet customer needs. We aim to position our solutions effectively in the market to address industry challenges comprehensively, fostering growth and efficiency. Our approach involves offering cus - tomized solutions where necessary to meet specific client re - quirements, ensuring optimal effectiveness and productivity. Q Kindly mention about the significance and strategy of Veolia’s Pharma segment in India? Gopalakrishna Madabhushi: The pharma industry is pivotal for us, especially in India, which serves as a pharmaceutical hub with high growth potential. We are committed to bringing international technological solutions to support the industry’s growth while ensuring compliance and environmental sus- tainability. Our aim is to be a strategic partner for the pharma sector, providing ecologically friendly solutions to enable effi - cient and responsible growth. PHARMA INDUSTRIALINDIA · MAY-JUN 24 13 INTERVIEW