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Pharmaceutical Manufacturing and Packing Sourcer

Information is Power

Increasing regulatory scrutiny, unprecedented pricing pressures, expiring patents and growing competition are resulting in the need for the industry to streamline its business and production processes, speed up time-to-market and reach ever-more stringent patient safety standards. With a technological revolution in full swing, only the agile will remain competitive.

Perhaps the most discussed theme in modern industry is the so-called Industrial Internet of Things (IIoT), also known in some manufacturing and production environments as ‘smart manufacturing’ or even ‘Industry 4.0’ – the latter being nod to the idea that we are rapidly approaching the fourth industrial revolution. Whatever you call it, as the industrial counterpart to the Internet of Things (IoT) that is driving a consumer technological revolution, IIoT promises to have a similar farreaching impact on society, the consumer, and the economic growth path in the 21st century.

There is already evidence of the huge benefits to be gained in terms of efficiency, profitability and product development speed for forward-looking pharmaceutical enterprises. Furthermore, it offers the most direct route to the necessary improvements in traceability and product serialisation, which are increasingly required to remain compliant and, consequently, sustainable. In short, the time for IIoT has come – and not a moment too soon.

IIoT and Pharma

It can be argued that the pharma industry has become characterised by increasing regulatory requirements, together with large numbers of plants with diverse automation and information systems, and stringent manufacturing conditions. Driven by legislation, globalisation and consolidation through mergers and acquisitions, and the need to reduce timeto-market, the complexity of the industry’s manufacturing environment mandates extraordinary control, recording and documentation capabilities. It requires a level of connected, integrated and contextualised information perhaps unlike any other sector in the world.

At the heart of IIoT advancements in pharma are the integration, flow and analysis of information. This can be referred to in terms of working towards being a ‘connected enterprise’. While many of the advantages of IIoT, like IoT in the consumer environment, are yet to be fully realised or understood, one thing is certain: that the free, secure flow of information through the enterprise is its language.

Importantly, having a connected enterprise does not need to wait, nor does it need huge capital investment. Rather, it involves a step-by-step process to connecting the operational technology (production and processes) to the enterprise technology (the business suite). This connectivity provides for real-time information flow that informs on the operational efficiency of a plant’s performance, such as equipment utilisation and capacity. This, in turn, enables the business to be proactive in optimising plant performance through its planning, scheduling, and predictive and preventive maintenance activities while reducing waste, managing stock levels and improving profitability.

Connected Enterprise

Over time, the challenge felt throughout the industry has been the legacy of equipment processes, obsolescence management and retaining the validated state. As a consequence of this, the plant became disconnected – or a term we refer to as ‘islands of automation’. Today, it is more about ‘islands of information’. In manufacturing terms, the obstacle to overcome is the disconnect of data that restricts the ability to be informed across the business. It is about bridging the gaps between the R&D process, the pilot and clinical trial stages, the upscale to manufacture, and the distribution to retailers and, ultimately, the patient.

Achieving this level of information connectivity includes the need to replace and optimise – or at least upgrade – existing mainframes and databases on the peripheral area network, in order to engage and comply with the standards for network interfacing. There is also a need for data integration between multiple sensors and external sources. Every item of data must be presented in the same syntax and structure in order that the system and its controllers fully understand the relevance and meaning of the combined information.

Two other key considerations are scalability and flexibility, which must be addressed at the early planning stage. The volume and velocity of big data requires that backend databases and functionality must be scaled up to evolve in the more complex environment, and as IIoT technology itself advances further.

Security and Legislation

Of course, the need for data privacy is a given. With examples rife of companies that have had their customer and employee data stolen, along with details of production processes and internal finances, it is not surprising that governments are racing to instigate more stringent controls and legislation.

Not only will business and economic needs drive the IIoT pharma industry, but so too will current and future legislation. The interface between the manufacturer and customer will come under progressively invasive regulation and be required to conform to certain standards and certifications. In Europe, IIoT clearly comes within the scope of the EU’s plans for regulation of the Digital Single Market; therefore, any IIoT development would be wise to integrate these considerations into its planning.

Meanwhile, the industry faces the global challenge of a rampant counterfeiting problem. With global legislation demanding anti-counterfeit measures that are now a pre-requisite to sell in an growing number of countries, the traceability and electronic pedigree provided by IIoT technologies will help in the fight against falsified medicines.

Indeed, there are already a number of ways in which counterfeiting can be tackled, which start with making it physically difficult for criminals to replicate products, including technologies such as barcodes, distinctive packaging, watermarks, tamper-proofing and so forth. More advanced strategies, however, are directly aided by IIoT technologies. Digital security – serialisation, for example – aids in product traceability throughout the supply chain, from production to patient. The technology and embedded systems and procedures also tighten up process security, which minimises vulnerability, reduces the potential for internal theft or fraud, and safeguards against external threats or counterfeit introduction into the supply chain. But in order for it to work, it relies wholly on the connected enterprise enabling the data flow and visibility of information.

Changing Healthcare

It is worth considering the advantages of adopting connected enterprise principles as part of the technological shift that can change the quality and efficacy of healthcare as a whole.

According to analysis by Mind Commerce Publishing, the healthcare sector is expected to be the fastest-growing segment in the commercial IoT market in the coming decade – rising by more than 15% each year. This increase touches each stage of healthcare, including prevention, diagnosis and treatment. The ‘smart wearables’ market, which encompasses devices used to aid healthy lifestyle choices and health issue diagnosis, is expected to expand at a compound average growth rate of 84.1% through to 2019 (1).

Meanwhile, we are able to observe how smart packaging of pharmaceuticals is helping to improve patients’ treatment, by reminding individuals to take medication when needed and in the quantity diagnosed – a problem that is estimated to cost the health industry around $300 billion annually in the US alone.

Within the clinical environment, the explosion of data continues, with body sensors being used to constantly monitor patient health and react seamlessly with medication provision. A notable example of this is for diabetes patients, who can be fitted with a device that not only takes real-time measurements of blood sugar levels, but also analyses that data and controls the levels of insulin released into the body via an automatic, on-board injection pump. This device is effectively a real-time, closed-loop automation system within the human body.

Shifting focus to the production environment, some of the changes instigated by IIoT can already be observed. Sensors and equipment are connected on the production floor, with data relayed in real-time for analysis to a central location – not unlike the diabetes pump. This connectivity enables the remote supervision of previously disconnected automation and information systems, producing the efficiency and effectiveness advantages already highlighted.

Each of these technological advancements have one important feature in common: they all rely on – and produce – much more data than we have ever had access to before.

Thinking Ahead

Take a moment to allow the data to join the dots, and it is possible to envision a future that links the production of pharmaceuticals directly to the patient – thus enabling a seamless supply chain. While a wearable device, for example, informs the individual about their health, it may also be used to collect anonymised data that could help manufacturers and healthcare professionals to know more about the direct needs of the patient group, in order to support targeted medication development.

The collation and analysis of this data, in combination with data from millions of other individual devices, examinations and treatments, could inform the manufacturer in real-time about the needs and trends of the market, as well as the therapy’s performance. It could also notify a patient’s doctor about their individual needs and habits, with the purpose of supporting a personalised medication programme. At the risk of heralding a dystopian future, it is not impossible to imagine such information being used (anonymously or otherwise) by insurance companies. While this level of connectivity is not yet a reality, it is entirely conceivable, and will change the way that pharma works across the entire length of the supply chain and product lifecycle.

Rise of the Machines

It is possible to envisage the future technology that will benefit from the more connected enterprises that underpin the IIoT, by looking at the latest intelligent track systems for packaging and materials handling.

With the growth in generics manufacturers challenging Big Pharma’s products as their patents expire, technologies and business processes must have the ability to drive down costs, while maintaining the quality and efficacy standards required by the regulators to ensure patient safety. An example of this would be a facility that manufactures a wide range of products and formulations requiring a flexible and agile production environment, so as to optimise their operations.

By combining linear and rotary motion into a single machine which uses individually controlled movers, manufacturers can benefit from vastly improved accuracy and efficiency, with infinite programming possibilities that reduce changeover times dramatically. This, in turn, makes shorter runs more profitable while increasing the inherent agility of a manufacturer.

The Future of IIoT

IIoT is already having dramatic and positive effects on the pharma manufacturing industry. It is transforming the maintenance and monitoring of production processes in those organisations that have implemented the new technology into their system and procedural structures. Of equal importance is the way in which it is improving the diagnosis and treatment of patients around the world, as well as the critical economic impact that experts estimate will run into trillions of dollars.

In order to benefit from IIoT, organisations must first understand the outcomes attainable, which include the creation of value, reduction of costs, and improvement in security and working practices. In the real-time environment, rates of production can be ratcheted upward – but only if the manufacturing environment is designed and set up to do so through the adoption of a connected enterprise approach. The greater efficiency and accuracy of modern motion technology empowers the connected enterprise to realise its full potential.

Reference
1. IDC Worldwide Quarterly Wearable Device Tracker, June 2015. Visit: www.idc.com/getdoc.jsp?containerId=prUS25696715

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Dean Chespy is the UK Life Sciences Industry Manager at Rockwell Automation, where his role involves coordinating a wide range of the company’s technologies and lifecycle services businesses that offer a value proposition, through solutions specific to the UK life sciences sector. His experience spans across the implementation and use of automated high-technology solutions, advanced production and information-based methodologies. Dean’s education lies in electrical and electronic engineering, and he has worked in the electronics and pharmaceutical manufacturing industries for more than 30 years.
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