Express Pharma

‘We wish to equip the pharma sector with technology that seamlessly functions with highest accuracy’

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Kalidas Bhangare, MD, Testo India, speaks on his company’s offerings for the pharma sector and their ability to drive both, quality and compliance, in an exclusive interview with Lakshmipriya Nair

How is the Indian pharma market evolving? What are the growth opportunities opening up in the pharma sector, globally and in India?
Pharma is probably the most important and critical industry sector among others. Upcoming biopharma companies, new medicines/drugs and latest technologies are creating an infrastructural renaissance. Government of India’s Pharma Vision 2020 aims to make India a global leader in end-to-end drug manufacturing. On a global level as well, there are so many advancements that are phenomenal. As per studies, nearly 200 new drugs are forecast to be launched in the next five years, with a high number of new molecular entities (NMEs) expected to be launched annually. Artificial intelligence is becoming very prominent to achieve greater efficiency with inclusion of analytical tools and cloud technology. Innovation will also be driven by an increase in collaboration across the pharma sector where companies with different facilities come together to create more value products. R&D, testing and experiments have increased for good. So much of development in the sector ensures greater growth opportunities.

What are the trends which would shape the industry in the recent future? How poised are you to leverage these opportunities?
System automation and digitalisation has almost taken over the industry where processes and work practices are becoming more self-driven with less human interventions. The existing trend included building management systems where the entire building used to be monitored and kept under control so that there are no deviations from the standards. But, now the entire sector is taking a leap with more inclusive technology which is environment management system (EMS) where the building climate along with the equipment and instruments are controlled through a common management system. Testo strives to answer the emerging needs of the pharma division with our products that help in climate monitoring, air quality measurement, maintaining necessary ambient temperature, humidity and differential pressure etc.

What is your vision for the India pharma industry? What kind of new paradigms do you want to usher into the industry today?
Testo India, as market leaders for measuring instruments and data monitoring systems, understands that no other sector is as strictly regulated and monitored as the healthcare and pharma sector. With our products for environmental monitoring and data logging, we wish to equip the pharma sector with technology that seamlessly functions with highest accuracy and fortifies the process. With such seamless solutions, you have the certainty of always being on the safe side be it in the manufacture, storage or transport of pharma products. Testo data loggers and Testo Saveris data monitoring system play a very crucial role in shaping up this segment. Our data loggers are EN 12830 and 21 CFR Part 11 compliant, which ensure complete documentation of parameters, be it humidity, temperature or absolute pressure. These data logging systems are totally audit proof as the reports cannot be altered or lost and is safe with the software. Another advantage that it brings is the surety of highest data compliance for audits and inspections because even 99 per cent certainly is not enough in pharma industry.

How is automation and digitalisation changing the way the sector operates? How will they shape the sector’s machines, methodologies, processes, and most importantly, its workforce?
A sector like pharma which is governed by strict norms and regulations must operate with full efficiency. Automated processes and increasing digitisation of the existing systems can surely provide the desired results. Testo Saveris system for instance, is an automated system suited for temperature and humidity monitoring in the pharma industry. This system is 21 CFR Part 11 compliant and constitutes of wireless or ethernet probes that are connected to one base station which documents and monitors all measurement data of its own uninterrupted making the process full proof. It even provides a number of alarm options for non-favourable situations to reduce human efforts and mistakes.

What is the competitive edge you offer to your customers through your solutions? How cost-effective are they?
As mentioned, our data loggers and monitoring systems for pharma are 21 CFR Part 11 compliant. Testo Saveris system is one-of-its-kind which is a mixed system that provides option of both wireless and wired probes connected to the base station. Another unique advantage of this system is that data from multiple locations or areas can be monitored centrally at one location via VPN network i.e. probes at multiple locations such as in QC labs, store room, process control lab, clean rooms etc communicate to the centrally located base station. This is a major step ahead in the T&M industry. Apart from what the product delivers, Testo also has a NABL-accredited service and calibration LAB that takes care of the after sales support locally from Testo India head office. This facility is highly cost effective as it delivers international standards very conveniently.

What are your growth plans and strategies for the next three years? How would you raise funds for expansion, especially in a scenario where businesses are finding it difficult to find investors?
India is termed as an emerging market and the numbers are only growing. In a very short span of time from its inception, Testo India has grown exponentially, thanks to our advanced products and German technology. Our manufacturing unit is in Germany where nearly 10 per cent of the total company turnover is utilised for R&D purpose in innovation, analysing new application areas and requirement of customers and accordingly coming up with the solutions. Ensuring our legacy, we have come up with our latest offering for the pharma sector, testo 190 data logger system for validation of sterilisation and freeze-drying processes with unbeatable efficiency. The system comprises five data loggers for temperature and pressure, 21 CFR Part 11-compliant software with audit-relevant reporting and two multifunction cases. All models are produced in stainless steel and robust polyether ether ketone (PEEK). Designed especially for the pharma industry, this testo 190 product family is ideally suited for tightness or overpressure testing in autoclaves and freeze-drying systems also efficient temperature monitoring of sterilisation and freeze-drying processes. Simultaneous configuration and readout of several data loggers via the multifunction case is possible to ease out the measurement process.

A data–led revolution is opening up new avenues for decision making across all functions of the pharma industry. Tell us how Testo India is providing added value and innovation in this landscape with its products?
Yes, it is true that the segment is data driven and the emphasis is on data which can include measurement values as well. Also, due to stringent norms in the pharma industry, it becomes obligatory to adhere to correct data and reports. Data security is one of the major concerns. Testo offers exactly that along with comprehensive analysis and evaluation of all the recorded measurement data. Our data loggers come with professional software where the data recorded cannot be tampered. Testo Saveris data monitoring system comes with three levels of access set up where we can restrict the authority to access the recorded data to three individuals. Also, there is a facility to provide only viewing access if need be. With this system, the data is stored in the probes, so even if software connectivity is lost the data is safe and can be downloaded once the software is logged in. Our system supports the user as they can monitor, record, analyse their data at any time and eventually carry out actions and decisions based on the reports.

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