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Pharma 4.0 and the pharmaceutical engineering industry of the future

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Allied with scientific advances and the next wave of inter-connectedness brought about by cloud computing, blockchain technology, IoT and advancements in artificial intelligence, we are in the midst of a revolution called Industry 4.0.

The first industrial revolution, Industry 1.0, began more than 300 years ago when we started mechanisation of processes. Originating in Europe and the US, Industry 1.0 was driven by water and steam power based equipment.

There were innovations in chemical manufacturing and iron production processes as well as the development of machine tools which led to the mechanical factory system of the day. 

Industry 2.0 came about nearly a hundred years later, catalysed by scientific breakthroughs in harnessing electrical energy. While shorter-lived, Industry 2.0 saw several advancements in manufacturing and production technology, allowing expansions beyond just factories. Industry 2.0 was the bedrock of global communication systems via the introduction of telegraph networks. Rail networks became more viable, thanks in no small part to improved steel production processes. Sewage lines and water supply systems also began to make further inroads into less urban areas in this time. Electric power and telephone systems were invented and made mainstream, allowing for a global communications network. A significant measure of the globalised economy we live in today is because of the innovations facilitated by Industry 2.0.

Industry 3.0 was the beginning of the shift from mechanical, analogue systems to digital, electronic systems. Spanning the best part of two decades from the 1950s to the 1970s, Industry 3.0 coincided with the beginning of computing and the explosion of electronics. Integrated circuit chips, transistors, digital logic boards, the ubiquitousness of telephones and then computers and then personal computers, all hastened the transition to increased automation in production and speedier communication of change at all levels. With technology progressing in leaps and bounds, this period saw innovations bursting forth at breakneck speed, shaping and reshaping the world around us constantly. This flux also heralded the arrival of enhanced automation and advanced computing and robotics into the manufacturing process.

Industry 4.0 is the inevitable extension of Industry 3.0. Dependent on cyber-physical systems and spanning the Internet of Things, Cloud Computing, Cognitive Computing, Industry 4.0 leverages innovations like blockchain to simultaneously accelerate production while minimising mistakes and errors, offering radical improvements in distribution and supply chain management. There is no specific distinction between hardware and software anymore. They work together as a homogenous computing entity to execute the function for which they are designed. 

Cyber-physical systems (CPS) are physical and engineered systems, whose operations are monitored, coordinated, controlled and integrated by a computing and communication core. Just as the Internet transformed how humans interact with one another; cyber-physical systems will transform how we interact with the physical world around us.

The ‘cloud’ is a paradigm shift in Information and Communications Technology (ICT), through which businesses and users can have on-demand network access to a shared pool of configurable computing resources. This will offer new opportunities for CPS in the management and processing of aggregated sensor data and decision-making methods based on a cloud model.

At its core, IoT is simple: it’s about connecting devices over the Internet, letting them talk to us, applications, and each other. The popular, if silly, example is the smart fridge. What if your fridge could tell you it was out of milk, texting you if its internal cameras saw there was none left, or that the carton was past its use-by date? But IoT is so much more than smart homes and connected appliances. It scales up to include smart cities – connected traffic signals that monitor utility use, or smart bins that signal when they’re full. Think of industry, with connected sensors for everything from tracking parts to monitoring crops.

Blockchain is a way to structure data, and the foundation of cryptocurrencies like Bitcoin. This coding breakthrough, consisting of blocks of transactions, allows users to share a digital ledger across a network of computers without the need for a central authority. No single party has the power to tamper with the records. There are many different Blockchains – public and private – and they allow anyone to send value anywhere in the world where the blockchain file can be accessed. 

Cognitive computing is the simulation of human thought processes in a computerised model. It involves self-learning systems that use data mining, pattern recognition and natural language processing to mimic the way the human brain works. The goal of cognitive computing is to create automated IT systems that are capable of solving problems without requiring human assistance.

Companies and even civic governments globally are applying Industry 4.0 to improve production capabilities and streamline distribution efforts. And pharma is not an exception. Industry 4.0 has immediate and intensive applications for Pharma 4.0.

Like BlockVerify, a system built on blockchain which makes it impossible to duplicate products, thus putting an end to counterfeiting.

Pharma warehouses can apply Industry 4.0 at every stage in the warehouse from stocking input materials automatically to intimating QC and then supplying materials to QC using robots. Once cleared by QC, materials can automatically be delivered to production and the finished stock can be restacked in the same way. QC of finished product and subsequent packaging and pelleting too can be fully automated without needing human intervention.

One of the issues with manufacturing facilities around the world, and especially in Asia, is that automation is only an island in the manufacturing facility. Expanding state-of-the-art automation platforms to other processes within the manufacturing facility will not only hasten production timelines, it will also significantly reduce costs in ensuring regulatory compliance.

Lab automation is another excellent use case for Industry 4.0 in pharma. Since electronic data is easier to find, more legible, and records can be linked between sources, it helps with expedited quality assurance approval. There is not even need for secondary review, as calculations are automated and data are collected directly from devices like balances and pH meters. Lab automation can ensure a common inventory of chemicals, reagents and stock solutions with flagging of expired certificates of analysis. Data from the ELN (e.g. sample details, sample weights, standard concentrations) are transferred electronically to LIMS for quantitation and reporting.

Most pharma manufacturing facilities still have a lot of labour-intensive processes. Not only are these prone to human error because of indiscipline, ill-health or simple fatigue, it also doesn’t lend itself well to consistently excellent workmanship. Applying automated systems to these processes ensure less variability in the manufacturing process and greater control and consistency of product quality. Increased process control also makes more efficient use of materials, resulting in less scrap.

One of the most critical elements in the pharma distribution ecosystem is the cold chain. Relying on human or manual processes to manage the cold chain and mitigate potential issues is not ideal. Industry 4.0 has a major role to play in transforming this using computational models to analyse potential impact of storage and shipping environments and make required modifications to the cold chain as needed instantaneously. Excursion no longer needs to be a worry that requires constant manual checks. 

Supply chain management (SCM) in pharma is extremely complex, especially when you factor in global supply. Product Standards, packaging and labelling requirements vary from country to country. Environmental and temperature protection requirements are diverse. Recalls need to be tracked and traced. Instead of using multiple diverse systems, powered by human intervention, the supply chain can be fully managed by Industry 4.0 applications. Cloud computing, Blockchain, RFID tags, electronic records (especially useful to track recalls), cognitive computing for ERP and production planning and the use of cyber-physical systems in production can together make pharma SCM 100% fool-proof.

Electronic Batch Record Systems (EBRS) are a perfect solution for the pharmaceutical industry. Through a user-friendly Graphic User Interface (GUI), EBRS could provide an efficient way for automatic capturing of data, exchange of batch information, batch production management, report generation and for accuracy of operators. EBRS can also provide central storage of data to maintain data security and integrity. By providing functionality for application security, audit log generation, and e-Signature capture, EBRS would ensure that the system becomes completely compliant with the 21 CFR Part 11 regulations.

Even from a regulatory perspective, ensuring that all data from production, inventory management, supply and distribution is automated and stored centrally goes a long way in answering most of the questions, regulatory authorities might have.

It is not a question of when Industry 4.0 will arrive. It has been here for some time and continues to evolve rapidly, radically changing established ideas of production the world over across industries. The pharma engineering sector needs to be at the forefront of this disruption to ensure our customers can obtain the most benefit from these innovations. It is time for Pharma Engineering 4.0.

The author is General Manager – International Projects at Fabtech Technologies International Limited.

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