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Quality, safety & efficacy need attention in pharma

Gaurav Bawa
Wednesday, June 14, 2023, 08:00 Hrs  [IST]

The very nature of the pharmaceutical industry, which is aligned with medicines and life-saving medical devices, makes it different and susceptible to stringent quality control as compared to the other industries. Hence, the requirement of precision test and measurement technologies for the pharmaceutical sector has always been a matter of special attention, controlled and prescribed by government agencies such as the Food and Drug Administration (FDA), EHEDG (European Hygienic Engineering & Design Group), 3-A Sanitary Standards, ASME BPE for Bioprocessing Equipment ATEX (directive 94/9/EC) and many others.

Technology in pharmaceutical industry is ever-changing given that research and development (R&D) is pertinent in this sector, as virus mutates and challenges changes its shape, size and geography. Along with the technology innovations, the processes and with it the measurement requirements also change - thus making it more important for the conformity verifications to be rigorously defined and followed. As a result, sterile process engineering plays a significant part in the cost-effectiveness and safety of the production processes, in both upstream and downstream areas.

Expected growth of T&M market from pharma industry
In view of the high demands on the quality and product safety from pharmaceutical production, the demand for precision measurement in the industry is not only limited to manufacturing floor, but also applicable to further course of the process chain, up to cleaning and sterilisation, contamination-free processing, mobility and storage of drugs at certain temperature are all crucial quality factors. From measuring instruments, this demands a combination of the most up-to-date hygienic design and, at the same time, a high measurement accuracy.

The factors leading to an upsurge in the pharma industry are the following:
    1) Development of medical infrastructure, and proliferation of health centres at grass-root levels in developing countries are boosting demand.
    2) Increasing medical tourism is demanding growth of the test and measurement devices at an unparalleled speed for pharma industry.
    3) Coupled with these is the digitisation factor. Increasing demand of IoT-based medical devices such as diagnostic kits, cardiac monitors and implantable devices.
    4) Smart electronic medical kits for aging population as a result of increased life expectancy is also an important driving force of pharmaceutical products.
    5) The impact of Covid-19 has manifested in increased investment in research and development which also needs precision test and measurement equipment.

Mordor Intelligence Report pegs the growth of India Pharmaceutical Market at a CAGR of 10.7 per cent over the forecast period of 2019-2027. In the post-pandemic scenario, the sector is expected to witness healthy growth owing to the increased demand, digitalization, and surge in domestic production. For instance, as per the IES 2021 report, in the next decade, the domestic market is expected to grow three times, thereby boosting the pharmaceutical market over the next few years.

According to Invest India, the pharmaceutical industry is expected to reach $65 billion by 2024 and to $130 billion by 2030. The pharmaceutical industry in India is currently valued at $50 billion. Incidentally, India is a major exporter of pharmaceuticals servicing over 200 plus countries and thus it is pertinent that the manufacturing follows stringent and strict parameters for each country, thus using supplementary test and measurement scales.

Diversity of T&M requirements in pharma sector
The need for test and measurement instrumentation in pharma sector implies a wide range of products - right from the industry-standard and manufacturer - specific process connections in hygienic design such as clamp and aseptic connections, BioControl instrumentation for toxic bioactive and sensitive substances, viscosity testing instruments, refractive index and concentration measurement, meter dose inhalers, gel caps and many such items.

The infrastructure or shop floor where these are manufactured, to the refrigeration unit where the medicines are kept at retail shops, all need specified instruments to keep the chain running till it reaches the customers. Thus, even a little demand-side influx from the pharma industry means a lot of demand for the test and measurement (T&M) market, on which the entire back-end and front-end supply chain of pharmaceutical products depend.

Whether the requirement is to test the crush strength of pills, needle insertion, and extraction, actuation forces of metered dose inhalers, or push-through for blister packs, the testing material for pharma products is always precision-driven and customized to fit the exact needs of each producer - thus making the supply of these instrumentations more rigorous.
Just like medicines and pills themselves, the medical devices are also to be tested with the highest precision as their readings help doctors to take decisions about the patients. Typical parameters being measured in medical device testing include flexure, tension, compression, peel strength, adhesive/bond strength, puncture, insertion/extraction and sliding of pistons and many others.

Smart technology impact and demand of precision T&M
Latest technologies like AI, AR/VR, Big Data and Quantum Computing have been increasingly adopted by pharmaceutical companies to offer personalized products, accelerate R&D efforts and transform the experience for the user. As technology innovations gather strength in the industry, there is an equally increasing need to use precision equipment that can aid the functionality of each of these technologies. Thus, the dependence and use of test and measurement instrumentation will be on a rise along with adaption of smart technology.

Currently, artificial intelligence (AI) helps the industry in optimizing and automating the manufacturing process. AI combined with machine learning (ML) helps the companies to analyse the profiles of individuals taking each drug, their impact and efficacy - thus leading to precision research and development, so as to increase the effectiveness of the medicines and differentiate their potency for targeted groups.

Similarly, Big Data and Analytics, help researchers in the pharmaceutical industry to reduce time frame for each innovation. It helps reduce exploration cycles, making the discovery and development of new drugs quicker, including feedback on the side effects of a drug beforehand. This helps to reduce the time required for clinical trials and shorten the entire research process.

In the same manner, 3D printing and bioprinting has helped pharma companies test the safety and efficacy of drugs without using live subjects - human or animals. The 3D bioprinting helps create imitation of human organs and tissues that reacts like live subjects thus giving real time reaction as human organs to new drugs and medicines. Blockchain of course ensure traceability of drugs and manufacturing process right from shop floor to the application to the patients in an accurate manner and generates reliable data that binds the manufacturing and supply chain process, erasing any scope of duplicity. This ensures visibility from top to bottom of the supply chain with data, bringing in process efficiency.

Each of these applications - AI, blockchain, Big Data, 3D printing need complex machines that can deliver accurate results, as in case of pharma industry, life depends on the deductions. In turn each of these machines are dependant of micro instrumentation that help them perform better and precisely. Test and measurement instrumentation are pertinent to any smart machines that are being used in any industry, including pharmaceuticals.

Way forward
With the demand for smart techniques of production and smart electronic devices on the rise, pharma sector is also looking at 5th generation ultra sensors, environmentally friendly processes and disposal, efficient monitoring and predictive maintenance.

The test and measurement industry needs to be fully equipped to address this intense challenge that is expected to come from the pharma sector on an ongoing basis. Innovation, perseverance and close attention to dynamic customer needs will characterize the successful T&M instrument manufacturer for pharma sector.

(Author is senior vice president of WIKA India)


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