Automating Pharma: For accuracy and precision

September 13, 2019 3:04 pm

Ever since technology has opened ways for fundamental improvements in manufacturing, automation has been taking over the manual processes in the pharma industry. We have industry leaders discussing why automation will take India to places and why the pharma needs to be free of human contact for precision.

Redefining Pharma with automation
Automation in pharma is highly regulated and is governed with all complexities throughout the entire life-cycle of industry, including the new solutions, designs, research, or any new invention and findings, among the others. This can be termed as an automated health care/personal healthcare solution.

Sharadi Babu, CEO, AXISCADES says that there are certain rules which are applied to the entire industry, but in various forms and factors. During the initial R&D stages, the design also is automated as we need variations of the required/formula, as we have certain formulas which are designed with certain specific drugs only. The moment you realise of the result or the end composite of the mixed formula, you initiate the automation process, but with precision.

Babu further says “The entire production of the subsystems has to be in line with the automation process because during the production processes we are exposed to hazardous chemicals. So, automation would play a crucial role here as we won’t be having human intervention into the process, and would act on its own after a predetermined program is installed in it.” Some countries flout some of the rules, but in almost every developed country, including India; human intervention is not permitted, in the designated chemical processes. The accuracy and the mixing of these chemicals are far more essential for remittent drug quality.

Whereas, according to Anil Bhatia Vice President and Managing Director, Emerson Automation Solutions today, drug makers have state-of-the-art manufacturing facilities that are driven by robotics, AI and cutting-edge tech-enabled business processes, in alignment with Good Manufacturing Practices (cGMP) and U.S. FDA regulations. Recipe processes now go through multiple automated stages as the industry transitions from batch to continuous manufacturing. Emerson has the automation expertise and technology to solve some of the greatest cGMP manufacturing challenges and create effective solutions for improving data management, real-time product quality, reliability, operating costs and safety. From design to implementation and startup to on-going optimisation, pharmaceutical industry can rely on Emerson to stay competitive in a global economy.

Further, the accuracy and precision of every single chemical component is highly important in the resulting drug quality. Today, India is one of the global manufacturing hubs for all types of tablets, capsules and syrups. Importantly, the formula and the OEM may differ. For instance, most of the drugs are formulated and tested in US and other countries, but the manufacturing of end result drugs and the exports are being made from hubs like India. We can say that this industry is completely driven by automation and is controlled by global OEMs. Further, the OEMs don’t want to experience any shortcoming in the entire process. Certain regulatory board is responsible for the certifying all the drugs, which is further audited by global auditors.

Manufacturing medicines free from human contact, under Pharma 4.0
Science is fuelled by data, thus proving the validity and reproducibility of data is an integral part of Pharma R&D labs and manufacturing plants. In the digital era, Pharma 4.0 is all about Robotics and Artificial intelligence, that will fuel the growth of drug manufacturers to sustain the global competition, boost time to market, meet the FDA and global regulations, and produce life-saving quality products.

Terming the step as an essential aspect, Babu says, “Considering the hazard global OEM requirements, automation has been largely utilised in the pharma industry. Interestingly, pharma is the one particular sector, where you can find very innovative, miniature automation techniques. The automation process environmentally controlled, considering the health and safety concerns of the consumer and the production facility. Not just the environment, but the work ability, machinery maintenance, operations has to have quality equipment and automation processes.”

Automation improves validation of data, compliance and minimises deviations by connecting instruments to electronic systems, so users don’t have to manually intervene the process. According to Bhatia, “Pharma 4.0 is definitively transforming this sector, with regards to product development, commercial production and real-time monitoring. It can foster manufacturing excellence by leveraging sensors and identification systems to not just help companies achieve compliance, but also to do so at the lowest costs. Emerson’s flagship products, DeltaV™, Control System platform and Digital IIoT solution, Plantweb™, are helping phama industry – achieve operational excellence with reliable processes and safe and cost effective operations.”

Some countries have liberal rules, but most of the countries have very stringent regulations, by not allowing any human interventions in particular processes. However, for out-sourced projects and products, companies with human intervention into the processes wouldn’t be considered.

Curbing manufacturing malpractices in non-generic medicines
Pharma industry highly control, manage and regulate the malpractices by identifying them and preventing them from harming the process and the products. As the process becomes more viable, it is applied to the manufacturing industries for both generic and non-generic drugs as we ensure on the quality deliverance. However, Babu highlights that “Malpractices take place, when you are not sure of the drug’s combination, formula and the end product. Moreover, you are unsure on the quality of the chemicals and formulas and subsidiaries being used, whether it is certified or not, whether the testing process was according to the specified guidelines, were the processes and the test results approved.

Malpractice can happen at different stages and various approval junctions. There are structural balances provided by the government and federal agencies. Babu further adds “I think, the verification and approving process must be strengthened and must be more stringent. Strict implementation and compilation is highly required to curb such practices.”It’s important that a design of any pharma product is tested and approved. The required composition and the designed composition must match and must stand correct. This is why, prototype testing is mandatory in the pharmaceutical industry.

It can foster manufacturing excellence by leveraging sensors and identification systems to not just help companies achieve compliance, but also to do so at the lowest costs.
Anil Bhatia Vice President and Managing Director, Emerson Automation Solutions

The verification and approving process, along with strict implementation and compilation is highly required to curb malpractices in pharma.
Sharadhi Babu, Chief Executive Officer, AXISCADES