Mumbai, December 2022
The 15th edition of CPHI & PMEC India 2022 was kicked off at the India Expo Centre in Greater Noida, Delhi-NCR on November 29. SOPAT, a cutting-edge technology provider in the field of inline process instrumentation, is proud to be a part of this 3-day trade fair along with its Indian partner and distributor, Spinco Biotech Pvt. Ltd. Both CPHI India and its co-located event, PMEC India, are considered major trade fairs for the pharmaceutical industry in a post-covid era. They are conceived as a marketplace where senior pharmaceutical executives, procurement managers, OEMs (original equipment manufacturers), contract development & manufacturing organizations and technology providers confer and arrive at innovation-driven solutions to make manufacturing practices more sustainable, lean, automation-driven while maintaining the product’s safety, efficacy and quality. Over the course of three days, the event certainly seemed to deliver on this promise.
Currently valued at 50 billion dollars, the Indian pharmaceutical sector is expected to make momentous leaps and become a 130 billion dollars industry by 2030. Given the important role of India in the global pharmaceutical marketplace, SOPAT considers it very important to participate in this innovation-driven rally by the industry towards making manufacturing practices more efficient, safe and economical.
Particle size as a critical quality attribute
Building quality into pharmaceutical processes is the leading purpose of the process analytical technology (PAT) initiative by the FDA and thereby a core building value for Sopat. Particle size is a critical quality attribute in a number of pharmaceutical unit operations such as emulsification, coacervation, crystallization, suspensions, granulation, spray drying and pelletization. An adequate particle size distribution (PSD) is essential to ensure the end product’s safety, efficacy, and quality.
Therefore, monitoring and controlling particle size via inline measurements is essential to the pharmaceutical industry.
With this in mind, SOPAT offers photo-optical inline particle analysis solutions which are ATEX compliant and qualified for use in aseptic environments which is a must when we speak on cleanroom technologies. Moreover, Sopat is also able to offer a multi-characteristic analysis in terms of CQAs (critical quality attributes) like particle shape, color, size, relative concentration and even turbidity. The raw data from the probes is images. Image data provides the user additional information that is critical to product quality. With Industry 4.0 in mind, Sopat has adopted neural networks and machine learning approach in its image analysis algorithm further reducing the gap between process and analysis. With the recent acquisition of Parsum GmbH, who are masters of their trade when it comes to inline particle analysis for granules, pellets, powders and other dry solid systems, the company is able to provide solutions for the entire spectrum of pharmaceutical applications.
At this year’s PMEC, Sopat and Parsum were placed as live and interactive exhibits at the Spinco booth, where potential customers could see a live demonstration of two systems. Dr. Mirco Wegener, Head of Sales and Marketing at Sopat, was present at the 3-day trade fair having engaging discussions with potential customers about the benefits of inline particle analysis. He had the following to say: “PMEC is one of the most important pharmaceutical trade fairs. Through our partner Spinco, we were given the opportunity to participate and present our technology at the booth. Thanks to Spinco’s commitment and the excellent knowledge of my colleague Rahul Rane, we were able to talk to a large number of existing and potential new customers during the three days we had available. Parsum’s IPP-80 inline probe was presented to an Indian audience for the first time and generated a lot of interest in this technology.”
Spinco Biotech has always been a close ally for Sopat for the Indian market. Mr. Sundaram Mohan, Country Manager, Process Analytical Technology at Spinco Biotech had the following to say: “After the pandemic outbreak, much awaited 2022 PMEC held at Noida witnessed a phenomenal participation both from pharmaceutical companies and technology providers. As always, Spinco showcased the new innovations and the technologies for future from our global partners. Without a doubt, the manufacturing technology, fill finish automation and process analytical technology segment such as robotic aseptic filling, freeze drying, homogenization, sterilization, inline particle measurement, container closure integrity, process NIR etc., took major attraction. With the kind of visitors’ feedback and interest towards inline particle measurement technology, we see tremendous growth opportunity in this field in the near future.”
In a post-pandemic world, where the need for sustainable and economic drug manufacturing is an important mandate, where research for improving the quality and effectiveness of drugs is an ever-evolving field, the presented solution-driven technologies help further this march. With inline analysis, the user can reduce operational costs through significant increases in throughput and productivity by reducing off-specification batches, improving batch-to-batch consistency and continuous monitoring of CQAs (critical quality attributes).
With the customer outreach and footfall that was experienced during PMEC 2022, Sopat certainly looks forward to the event next year.