|
Cognisant of the fact that the pharmaceutical sector lags the rest of the industrial world in the embrace of automation, the International Society of Pharmaceutical Engineering (ISPE) launched an ambitious initiative ‘Pharma 4.0’, which envisaged the transformation of the practices of the industry through adoption of some of the evolutionary innovations that characterise ‘Industry 4.0’. The overarching framework of ‘Pharma 4.0’ was centred on increased use of digitisation and automation as a step towards the creation of a ‘smart’ plant floor, replete with automated systems communicating with each other in real-time, and enabling fault detection, and correction without manual intervention. Although the stringent regulatory framework within which they operate is oft cited as the primary deterrent to extensive use of digitisation and automation in the pharmaceutical industry, it is ironic that automation solutions can ensure consistent compliance, while markedly increasing the efficiency of quality control systems.
The microscopic scales at which preparation of drugs are undertaken, coupled with the emphasis on a sterile working environment where there is no scope for contamination of any of the ingredients used in the manufacturing process warrant adoption of fool-proof methods. Automation allows for integration of standalone turnkey solutions with an existing manufacturing set-up, which, in turn, will allow the pharmaceutical firms to devote their attention exclusively to the core processes. Automated mixing, extraction, and pounding turnkey systems, which can be seamlessly incorporated within an existing set-up. Above all else, the impact that digitising and automating manufacturing plants will have on the profitability of firms – studies conducted by McKinsey have pointed to marked reduction in capital expenditure, ranging from 20 to 40 per cent.
Ensuring a hygienic working environment
The preparation of drugs involves the use of a number of toxic and reactive chemicals, which, while posing a direct threat to the safety of workers on the one hand, could have potentially fatal consequences, if not treated thoroughly before being used in chemical reactions, on the other. It is its ability to turn the entire process safer, and more hygienic that is automation’s biggest draw. Whether it is mixing, transfer of bio-chemically active substances, or filtration, automated turnkey solutions entirely eliminate the risk of contamination, while securing the safety of the workers. For instance, the transfer of hygroscopic material – substances that absorb latent moisture from the environment – is a highly sensitive process, which, if carried out manually, could result in spillage and contamination. However, automated ‘lift’ and ‘conveyor’ systems can ensure that this process is carried out with zero wastage. Furthermore, since it is a lot simpler to integrate such systems with Internet of Things (IoT) devices that can offer real-time data on the moisture content, temperature, and other ambient conditions. Such systems can ensure that procedures are halted at the slightest risk of contamination or the smallest deviation from the prescribed criteria.
Preparation of starch-based disintegration agents is another process the productivity of which can be greatly increased, not to mention prevent microbial contamination, once automated. Raw materials used in the extraction of starch – corn or potato – are susceptible to bacterial and fungal contamination. Turkey systems, fed extensive data about the manufacturing conditions and the criteria to be met, working in tandem with Internet of Things devices, can successfully integrate the many disparate procedures involved, including cooling and stabilising, to eliminate the risk of contamination.
Recycling and filtration systems
Preparation of drugs entails the use of copious volumes of water, which has to be processed successively before they are used, and as scrupulously treated before being discharged. Amid mounting concerns over dwindling supply of freshwater, pharmaceutical firms are increasingly turning towards recycling as a probable solution to the problem. However, treatment, and subsequent recycling of water used in pharmaceutical is a highly complex process, wherein all the parameters of the liquid – density, viscosity, et al – can be constantly monitored as it flows through the system. The automated system can ensure that data on the health of the water is constantly relayed back to the manual workers, who can use the information to determine if it is safe for the water to be discharged, or if it is safe to be recycled into the manufacturing plant for reuse.
Automated sensors can also be integrated into membrane-base ultrafiltration systems, to improve their efficiency. Membrane-based ultrafiltration systems are generally used in the pre-filtration stages that precede reverse-osmosis (RO) processes. It is imperative that reverse-osmosis units be protected from degradation that result from silt deposits on the vessels. This can be achieved by using IoT-powered sensors that can quantify the silt density index (SDI) on the surface of industrial vessels with unerring accuracy. Thus when sensors detect even marginally higher deposits of silt in the vessels, they trigger an alarm that enables the filtration process to be aborted without manual intervention.
Securing safety in hazardous processes
As a disintegration or binding agent, a diluent that ensures uniformity in texture of tablets, powdered sugar is used extensively in the pharmaceutical industry. Powdered sugar crystals used in the industry need to meet very precise norms, in terms of size and density. Pounding sugar, when done manually, often results in inconsistent texture and size. Furthermore, the process of reducing sugar to fine powder is carried out at temperatures ranging close to 150 degrees Celsius. Consequently, since sugar dust is inflammable, the process carries a potential risk for explosion, necessitating adoption of safety measures. More recently, both the food and pharmaceutical industries have been employing automated tools for pounding sugar, the benefits of which have been manifold. While preventing exposure of workers to such high temperatures, automating the process could ensure that the powdered sugar crystals conformed to the prescribed dimensions, in terms of size, besides the guarantee of required exactitude in terms of its constitution.
From motors and ball bearings to revolving grinding surfaces, there are several points where sugar dust can accumulate, triggering explosions that can prove calamitous to the infrastructure of a factory, and fatal to the workers. It is imperative that firms ensure strictest compliance to the European directive for Atmosphere Explosive (ATEX) processes. Automated systems, affixed with sensors capable of triggering an alarm in the event of accumulation of sugar dust on machinery, besides ensuring that all operations are carried out in a controlled environment.
Scope for a ‘smart’ drug factory
A US$ 1.4 trillion industry, the pharmaceutical sector will, in the coming years, only continue its expansion to keep the global population, estimated to cross 9.7 billion by 2050, healthy. Notwithstanding the capital expenditure that installation of automation equipment entails, the benefits of increased adoption of such ‘smart’ systems – increased efficiency, precision in operations, improved quality control mechanisms, ease of scalability – are likely to outweigh the initial costs. As industries across the board leverage the capabilities of Industrial Internet of Things (IIoT) – enhanced use of AI-powered machine vision systems, automated alarm systems, among others – the pharmaceutical sector is unlikely to be lag others in exploiting the potential of automation to drive both profitability and productivity.
(Author is Co-Founder and CEO, Cybernetik)
|