Manufacturers in the life sciences sector have been going through a period of continual change as organisations automate processes, integrate equipment, and make better use of data along Industry 4.0 principles. Part of this process of change is the growing trend to switch to Full Stack OT Platforms.

Full Stack OT (operational technology) Platforms are single-platform solutions that offer the functionality and features of both SCADA and MES systems. By implementing a Full Stack OT Platform, you will simplify your software stack while improving oversight, control, and productivity. Levels of integration will improve vertically through the organisation, from factory floor to ERP systems, and horizontally across your supply chain.

Modernising the Traditional ISA-95 Software Stack

The ISA-95 manufacturing software stack can trace its origins back to the 1990s. It has evolved over time, with the current versions typically having five levels:

• Level 0 – Component Level
• Level 1 – Field Level
• Level 2 – Operation and Control Level (or the Supervisory Control Level)
• Level 3 – Plant Level
• Level 4 – Enterprise Level

Advances in technologies mean there is now considerable functionality crossover between the best SCADA and MES systems. Modern platforms also offer additional benefits, including enhanced integration and better use of data.

Paul Clarke, CTO at SL Controls, said:

“Modern platforms also make it possible to unleash the true power of data in your organisation through data historian technologies, advanced analytics, and reporting capabilities, and by enabling automated decision-making.”

The Full Stack OT Platforms that Paul is referring to make it possible to flatten the traditional ISA-95 stack and move away from its hierarchical structure. In its place comes more of an eco-system solution that is better able to bridge the gap between IT and OT.

Choosing the Right Full Stack OT Platform

SL Controls has real-world experience of implementing Full Stack OT Platforms in life sciences sector manufacturing organisations. We have used that experience to develop and refine a selection process that ensures you get a solution that fully meets your requirements and delivers tangible results.

We have produced a whitepaper, authored by our CTO Paul Clarke, that makes the case for flattening the ISA-95 stack and switching from separated systems to Full Stack OT Platforms. Paul outlines the benefits of this approach for manufacturers in the pharmaceutical and medical device industries, before explaining the steps required to ensure the right platform is selected.

With our experience and expertise, we can assist with your technology and change management project, from planning and consulting to implementation and operation.

Download our whitepaper “Full Stack OT Platforms – Why They Are Needed and Selection Criteria Best Practices”.

Bridging the gap between IT and OT is a key objective for a growing number of organisations in the life sciences sector. The benefits of doing so are substantial, including having increased OT oversight and being able to use OT data to transform business operations. When bridging the IT/OT gap, it is essential to understand the cybersecurity risks that are involved and how to mitigate them.

Cyberattacks on any organisation can have significant financial and reputational ramifications. In the life sciences sector, there are additional risk factors that are arguably even more important, including the risk to patient safety.

Therefore, prioritising and investing in cybersecurity is essential for life sciences sector organisations.

Competing Priorities

By taking steps to bridge the IT/OT gap, cybersecurity risks increase. In simple terms, IT security is mature and well-established. It isn’t perfect, but IT security is substantially more advanced than OT security.

Potential cybersecurity outcomes include production line shutdowns or compromised product batches. Bridging the IT/OT gap can also expose IT systems to OT cybersecurity vulnerabilities.

OT Cybersecurity Vulnerabilities

There are many reasons why bridging the IT/OT gap can increase cybersecurity risks, but most come under the heading of existing OT vulnerabilities, starting with the vulnerabilities created by legacy systems.

Legacy Systems

Legacy systems are common in many life sciences manufacturing facilities, and they are often central to operations. They also often run on outdated and potentially vulnerable software. Historically this has been tolerated, as uptime was considered more important than fixing something (by updating the software) that isn’t, from an operational perspective, broken.

Connecting these legacy systems changes the equation.

Cybersecurity becomes an essential consideration when connecting equipment to the internet that has never been connected before and, in some cases, was never intended to be connected when it was first developed and manufactured. These legacy OT systems typically don’t have built-in security features and where they do exist, they are often minimal and outdated.

Organisational Culture

The biggest cybersecurity challenges that organisations face are typically not related to equipment or machines. The biggest challenges relate to people, as people are often the softest entry point for a cyber-attack.

This applies when bridging the gap between IT and OT. You have the same people-related security issues that apply to any connected system, but you also have the added complication of disconnected teams. This common lack of coordination and collaboration between IT and OT teams increases cybersecurity risks.

Multiple Systems

OT typically comprises a mix of old and new technologies, equipment, and platforms all with different security features and vulnerabilities. The simple fact of having multiple systems increases cybersecurity risks.

There are then additional risk factors, such as OEMs being connected to their equipment for performance monitoring and maintenance reasons. While these types of connections bring benefits, they also create additional entry points for cyber-attacks.

All Production Lines Are Prototypes

No two production lines are the same, even if they are manufacturing the same product. As a result, all production lines in the life sciences sector are essentially prototypes with bespoke integrations and connections. This reality adds to the cybersecurity challenge.

Growth of the IIOT in Health Care

The industrial Internet of Things (IIOT) is transforming many aspects of healthcare with devices that monitor patients and control the administration of treatments automatically and in real-time.

All that new patient data increases the potential value of life sciences sector companies in the eyes of hackers and cybercriminals.

Existing Cybersecurity Solutions

It’s also important to consider existing cybersecurity solutions, as most are aimed at IT rather than OT environments. They are feature-packed, highly robust, and powerful, but they have an IT rather than OT focus.

This can present challenges in OT environments that exacerbate the cybersecurity problem.

Take multi-factor authentication (MFA) as an example. MFA is used in many organisations to beef up cybersecurity and ensure accounts, platforms, and systems are less vulnerable to weak, shared, or hacked passwords.

In a typical office environment, MFA is a small hurdle for users to overcome. They simply use their phone to get the access code from a text message or app to authenticate their login. How can you replicate this in the hygiene-controlled environments of pharmaceutical manufacturing facilities, medical device cleanrooms, or pharma laboratories?

An Introduction to Mitigating Cybersecurity Risks When Bridging the IT/OT Gap

We will explore in more detail in a future blog the mitigation steps that can be taken to reduce cybersecurity risks when bridging the IT/OT gap. The main points include:

• Flatten the stack – reduce the number of systems, particularly in the OT stack, to reduce the potential attack surface for cyber criminals.
• Technical steps – examples of technical steps that can be taken to enhance cybersecurity when bridging the IT/OT gap include creating secure access protocols at every endpoint, encrypting network traffic, and protecting both IT and OT with firewalls.
• Organisational management and people – ensure IT and OT teams work together, particularly on cybersecurity issues, while taking a holistic approach to security that includes both IT and OT teams. Continuously training staff on cybersecurity issues is also important.
• Vendor management – OEMs and software vendors are critical cybersecurity components, so they should be thoroughly vetted and managed.

The most important factor to mitigate risks when bridging the IT/OT gap is to put cybersecurity at the centre of your planning, with cybersecurity considerations factored into every decision and strategy implementation step.

CDMOs (contract development and manufacturing organisations) and CMOs (contract manufacturing organisations) have been a feature of the life sciences sector for many decades. However, this part of the sector is changing and growing, making externalisation an even more critical element of worldwide pharmaceutical and medical device development and production.

A lot of the change taking place within CDMOs and CMOs concerns the business models and strategies they are increasingly deploying. Traditionally, CDMOs and CMOs focused on capacity, often acquiring manufacturing facilities as the primary method of business growth. Today, however, the focus of CDMOs and CMOs is on offering value-adding services.

Capacity is still important, but the ability to offer hard-to-find expertise, industry-leading knowledge, and advanced technologies are some of the things that are making partnerships with CDMOs and CMOs such an attractive option for pharmaceutical and medical device companies.

An example is the ability to manufacture complex and challenging cell and gene therapies. CDMOs and CMOs with this capability offer so much more than straightforward manufacturing capacity.

How CDMOs and CMOs Work

The partnership arrangements between life sciences sector companies and CDMOs/CMOs vary depending on requirements and objectives. For example, large pharmaceutical and medical device companies often choose to outsource elements of a product development project to a CDMO. They could do this because of internal capacity or capability challenges, i.e., where internal resources are either not available or don’t have the right expertise or skillsets.

Startup companies, on the other hand, commonly choose to outsource entire projects, from product design and development to regulatory support to manufacturing and commercialisation. Choosing this approach means the startup doesn’t have to invest in premises, equipment, people, and technologies.

Common services that CDMOs and CMOs offer include drug development, medical device design, regulatory support, and manufacturing.

The Advantages of Partnering with a CDMO or CMO

Reduced Risk

In general, outsourcing to a CDMO or CMO can distribute the risks associated with manufacturing, especially in startups where a company doesn’t have prior manufacturing experience.

However, there is an even more important factor specifically related to the life sciences sector – mitigating business and process risks without compromising patient safety, compliance, or manufacturing productivity. One example is the risk of supply chain security, as partnering with a CDMO or CMO can improve the robustness of a product’s supply chain.

Speed to Market

Using a CDMO or CMO can accelerate the process of getting a product to market, especially if the partner has available capacity. Given the high levels of competition in the life sciences sector, faster speed to market timescales can have a considerable impact on everything from competitiveness to viability to profitability.

Access to One-Stop-Shop Providers

CDMOs often promote their offering as a one-stop-shop solution, covering all the stages of getting a product from the concept stage to scale-up manufacturing – and even beyond to ongoing product development and end-of-life processes.

These end-to-end capabilities are attractive to many companies in the life sciences sector as it reduces management complexity and can also reduce costs and risks.

Capacity

Getting access to available capacity is another major benefit of CDMOs and CMOs, whether that is compliance expertise to navigate the regulatory submission process, design and development expertise to develop a viable product, or manufacturing capacity to meet market demand.

Specific Expertise

As pharmaceutical and medical device products become more advanced with new and innovative technologies, it is becoming increasingly necessary to have access to specialist expertise. That expertise isn’t always available in-house, so partnering with a CDMO or CMO is an attractive solution.

Cost-Efficiency

Setting up in-house facilities and capabilities is costly, whether you are employing talent or investing in manufacturing equipment. These costs can be significantly reduced or eliminated by partnering with a CDMO or CMO.

This applies not only at the outset of a contract or project, but also ongoing as it will be the CDMO’s or CMO’s responsibility to ensure manufacturing equipment is upgraded and maintained, as well as to invest in new technologies.

Focus on Core Competencies

Partnering with a CDMO or CMO means your team can focus on your core business functions and competencies, such as R&D, marketing, and sales.

Scalability and Flexibility

Scaling up or down is easier when you partner with a CDMO or CMO. This flexibility ensures you can meet customer requirements when demand is high while minimising costs when demand is low.

Access to Advanced Technologies

Innovative and forward-thinking CDMOs and CMOs invest in the latest equipment and cutting-edge technologies to remain competitive. Partnering with a CDMO or CMO will mean you can also benefit from these investments.

Robust Systems and Infrastructure

CDMOs and CMOs will have robust and long-established procedures that can be immediately deployed on your project. This means you won’t have to spend time and resources developing these systems in-house.

Ultimate Responsibility for Patient Safety and Compliance

There is one final point to highlight before closing. More and more companies in the life sciences sector are partnering with CDMOs and CMOs as they calculate the benefits. However, it is always important to remember that, in the eyes of regulators (and patients), you remain ultimately responsible for product quality, patient safety, and regulatory compliance.

This needs to be considered when deciding to go down the CDMO/CMO route. If you decide this is the best option for your business, make sure you set clear expectations and requirements and ensure there is frequent, timely, and transparent communication. It is also important to continuously measure and monitor the performance of the CDMO/CMO, keeping a record of all monitoring activities in your quality management system.

By taking these steps, partnering with a CDMO or CMO can help companies in the life sciences sector achieve their objectives. As a result, we can expect the trend of growing CDMO/CMO use to continue.

Pharmaceutical and medical device companies are high-value targets for cybercriminals, making cybersecurity a high-priority consideration. A key component of good cybersecurity is adopting password security best practices.

Good password security is important to protect IP and patient data, as well as ensuring operations can continue without the often significant interruptions that can occur as a result of a cyberattack. There are also compliance considerations in the life sciences sector, including the data integrity requirements of 21 CFR Part 11.

Even minor issues in relation to password security can result in a major breach, but before getting into the best practices for password security, it is important to highlight the wider cybersecurity context.

The Starting Point for Good Password Security

To properly protect your organisation’s infrastructure, data, IP, and operational integrity, it is critical to ensure there is a solid understanding at all levels of the importance of password security.

This understanding shouldn’t be limited to technical or procedural considerations, i.e., how many characters a password should have or how often passwords should be changed. Technical and procedural considerations are important, but it is also essential to understand the evolving threat landscape in relation to passwords.

This includes understanding the nature of social engineering and phishing threats, both of which can put even the strongest passwords at risk.

It is still essential to follow password security best practices, but passwords need to be considered in terms of your wider cybersecurity strategy, policies, and defences.

Password Best Practices

Use MFA

Multi-factor authentication (MFA) ensures a password alone won’t allow access to a system. MFA should be implemented as much as possible in pharmaceutical and medical device manufacturing organisations.

Put in Place Effective Password Security Tools, Procedures, and Policies

There are steps that can be taken at an IT and operational level to improve password security in pharmaceutical and medical device companies. This includes implementing MFA, as mentioned in the previous point.

Other steps that can be taken include:

• Implementing password monitoring technologies and/or password managers, the latter of which help users set and remember complex passwords. In fact, with a password manager, users don’t need to remember their passwords at all, as the system does it for them. The result is a good user experience with strong password security, but it is a solution that also comes with a crucial risk that should also be considered – the risk of the password manager itself becoming compromised.
• Ensuring systems, software, PLCs, devices, etc. are configured so users can’t use a password that has been used previously.
• Automatically disabling inactive accounts and locking down accounts after a preset number of failed login attempts.

There are also some password security tools and procedures that are best avoided. This includes knowledge-based authentication systems where users are asked to answer questions like their mother’s maiden name. These types of systems can weaken, rather than strengthen, password security.

Another commonly used practice that deserves careful consideration before being implemented is requiring employees to change their passwords after a predetermined period of time. There is growing consensus among cybersecurity experts that regularly changing passwords has little effect on improving security and can even weaken your defences.

For example, a user is more likely to write down their passwords if they have to remember new ones every two or three months. Alternatively, a user might alter just one character in their new password every time they are asked to change it. Hackers are aware of this practice of making minor modifications to existing passwords. If hackers are aware of it, they can beat it.

Encourage Good Password Structure

Best practices for password structure include:

• Password length is arguably more important than random complexity, so insisting on long passwords will help to improve password security.
• While password length is important, it is also beneficial to make passwords a random collection of numbers, uppercase letters, lowercase letters, and symbols.
• Educate users on the importance of not using the same passwords at work as they do on their personal accounts.
• Educate users to avoid using common words. In fact, using words should be avoided altogether. Phrases are better (because they are longer) but completely random collections of characters are best.
• Encourage staff to avoid common practices that meet password length and character requirements, but which do little to improve password security. While a password like Ph@rm@c3ut1caL might look hard to guess, using character substitutes like this is so common that hackers are very good at guessing these types of passwords.

Encourage Good Password Protection

Creating a unique and long password made up of a random collection of characters is only part of ensuring password security. It is also important that users protect the passwords they create. Best practices for protecting passwords include:

• Encourage staff to avoid writing down passwords, even if they think the location of the written password is secure.
• Prohibit the sharing of passwords.
• Prohibit the practice of a user logging into a system for someone else to use.
• Encourage employees to use a unique password for every account and system.

Move to a Single Sign-On Solution

Single sign-on solutions allow users to access multiple applications and systems by authenticating once. This provides a good user experience, but it can also improve password security. The benefits of single sign-on solutions include:

• Reduces password fatigue as users only have to remember one strong password, reducing the practice of choosing easier-to-remember passwords.
• Decreases phishing opportunities as users only have one set of credentials to remember. This makes them more aware of unusual requests that could be phishing attempts.
• Centralises system, device, and platform authentication to make it easier to monitor and manage user access.
• Reduces the attack surface as there are fewer passwords to steal and fewer routes of attack.

Continuous Vigilance

Finally, continuous vigilance is essential to maintain good password security in the life sciences sector. This includes continuously reviewing policies as well as new technologies that can improve security. It also includes providing staff with regular training on password security and other cybersecurity topics.

Nothing is completely foolproof when it comes to cybersecurity, but following these steps and best practices will help to significantly reduce risks.

Automated Guided Vehicles (AGVs) and Autonomous Mobile Robots (AMRs) are technologies that are transforming the pharmaceutical and medical device industries. When implemented properly, they can help manufacturers in the life sciences sector overcome some of the most difficult of today’s challenges, as well as improving productivity, efficiency, and quality.

Both technologies are similar as they are both material handling solutions that don’t require human intervention or involvement. In this blog, we’ll look at the differences between AGVs and AMRs, as well as suitable applications for these technologies in the life sciences sector and the benefits for pharmaceutical and medical device manufacturers.

What are AGVs?

AGVs are the older of the two types of material-handling robots as they date back about 70 years. Recent advances in technologies have now made AGVs a viable solution for many pharmaceutical and medical device production applications.

In brief, AGVs combine software and hardware systems to navigate and perform in predefined areas via fixed routes.

What are AMRs?

AMRs are also material-handling robots but, unlike AGVs, they don’t have to follow predefined routes. Instead, AMRs navigate autonomously using onboard sensors, cameras, and software. In other words, they can dynamically plan their route and avoid obstacles in real time.

Applications for AGVs and AMRs in the Pharmaceutical and Medical Device Industries

AMRs are a more recent technology, but there are applications for both AMRs and AGVs in the pharmaceutical and medical device industries. Those applications include:

• Transferring raw materials from storage and facility intake areas to the manufacturing line.
• Transferring product batches between manufacturing process stages.
• Transferring manufactured products for storage or shipping, or to assembly or packing stations.
• Transferring packaging materials to packing stations on the production line.
• Transferring waste material to disposal, recycling, and reprocessing areas.
• Storing and retrieving products in warehouses.
• Conducting various operations in clean room environments to reduce the need for human involvement and, as a result, lower the risk of contamination.
• Hazardous material handling.

The Benefits of AGVs and AMRs

Operators currently perform the tasks that AGVs and AMRs can automate in pharmaceutical and medical device manufacturing facilities. Automating these tasks brings a range of benefits:

• Efficiency improvements through enhanced productivity and greater workflow consistency. For example, AGVs can eliminate delays in getting raw materials to the production line.
• Various labour benefits, including being able to assign operators to more value-added tasks and reducing the labour that is required.
• Consistent performance as AGVs and AMRs don’t get tired, distracted, or sick. Instead, they perform tasks repetitively and consistently. Even low batteries don’t have to impact performance as systems can be set up in fleets, where an AGV or AMR with a low battery can return to a charging station while another, fully charged unit, takes its place.
• Speeds up production in a variety of ways, depending on how the AGVs or AMRs are deployed. For example, AGVs/AMRs can ensure raw materials are transferred to the production line efficiently and without delay.
• Optimises material flow throughout the manufacturing facility.
• Reduces human error in areas like inventory management and material transportation.
• Enhances traceability and overall process improvement, particularly if AGVs or AMRs are integrated with MES, ERP, and other business process, production, warehouse, and supply chain management systems.
• Enhances compliance with sensors logging data about the materials being transported.
• Enhances production oversight by using the data logged by the sensors on AGVs and AMRs.
• Improves worker ergonomics and safety as AGVs and AMRs reduce the need for manual handling in pharmaceutical and medical device production facilities.
• Improves hygiene and contamination control, especially in cleanroom environments where AGVs can reduce the need for human operators.

Humans and Machines Working Together

The future of pharmaceutical and medical device manufacturing facilities is one where humans and machines work together, with machines handling repetitive and monotonous tasks to leave engineers, technicians, and operators free for more demanding, challenging, and value-adding tasks. AGVs and AMRs are essential components of the factory of the future. Their importance will only increase as technologies develop and they become more integrated into the production environment.

Manufacturing in the life sciences sector is dominated by large-volume, high-speed production facilities where business models are based on economies of scale. This approach has served the sector and society very well over the past decades, especially in the developed world. Now, however, there is increasing interest, research, and innovation in a different form of production – mobile manufacturing.

Mobile manufacturing is a type of decentralised production, where manufacturing takes place closer to the point of need. It offers many potential advantages to life sciences companies as well as to patients, but there are also risks and challenges. We’ll look at all of these points in this blog.

However, it’s helpful at the outset to highlight one of the main factors driving innovation in this area – personalised medicines, treatments, and devices.

There is still a need in the healthcare sector for mass-produced pharmaceutical and medical device products, so high-speed, high-volume production facilities are here to stay. However, there is also a growing need for alternative manufacturing approaches, such as batch size of one manufacturing, to make personalised and other low-volume novel products both commercially and practically viable.

What is Mobile Manufacturing in the Life Sciences Sector?

Mobile manufacturing solutions can take different forms, but they are often described as a factory-in-a-box. They often utilise continuous manufacturing processes that improve process control, enhance quality, maximise automation, improve flexibility, and increase efficiency. Mobile manufacturing solutions also often feature 3D printing and other additive manufacturing techniques.

Some of the most common characteristics of mobile manufacturing solutions include:

• Flexibility – flexibility of location as well as, often, flexibility in capacity and product, where the mobile manufacturing facility can produce different products in large or small quantities.
• Location – can be fully autonomous or installed in an existing facility, such as a hospital.
• Replicated – the unit can be replicated for multiple installations in different locations.
• Redeployment – the unit can be redeployed in a different location.

The Advantages of Mobile Manufacturing for the Life Sciences Sector

Societal and Healthcare Benefits

One of the main societal and healthcare benefits of mobile manufacturing is its potential to reduce the unequal access to medicines and treatments between developed and developing countries.

As mentioned previously, mobile manufacturing solutions also create viable production solutions for personalised medicines, including products that are difficult to manufacture using the high-volume, high-speed manufacturing model. Cell and gene therapies are a good example. The rapid manufacturing turnaround required by many cell and gene therapy products makes it highly beneficial to move production as close to the patient as possible.

Another societal and healthcare benefit of mobile manufacturing is that it enables a rapid response to patient demand, where products can be made available to patients faster than traditional manufacturing approaches.

Commercial Advantages of Mobile Manufacturing

The commercial advantages of mobile manufacturing include:

• More effective and efficient method of producing low-volume therapies and treatments.
• Potential cost-savings compared to the traditional approach of large-scale manufacturing facilities often located at a considerable distance from the point of care. This includes an enhanced ability to right-size the manufacturing process according to the product.
• Reduced capital investment risks as mobile manufacturing facilities can be built according to market demand, deferring large-scale capital expenditure until there is greater certainty of market success.
• Reduced risk of supply chain disruption where problems at one facility can have a wide impact on overall production.

Sustainability of Mobile Manufacturing

The sustainability benefits of mobile manufacturing include reductions in transportation costs to move medicines and other treatments from manufacturing facilities to the point of care. Smaller buildings/facilities also require fewer resources to build, run, and maintain, while right-sizing manufacturing based on the product can reduce the environmental impact of production.

The Commercial Factors Driving Innovation in Mobile Manufacturing

• Market size – smaller markets are more suited to mobile manufacturing and other decentralised manufacturing strategies.
• Scale of processes – small footprint processes are more suited to mobile manufacturing.
• Product maturity – where mobile manufacturing can be a more viable option for new product introductions.
• Speed to market – facility build times are faster and capital expenditure is lower with mobile manufacturing.

Practical Example of Mobile Manufacturing

This example comes from BioNTech, the German biotechnology company. In 2022, it introduced in Africa its new turnkey container-based mRNA manufacturing facilities for the production of vaccines. This mobile manufacturing solution enables the production of mRNA vaccines in bulk with fill-and-finish completed by local partners. The solution is capable of producing 50 million doses of the Pfizer-BioNTech Covid-19 vaccine a year.

Mobile Manufacturing Risks and Challenges

There are a number of risks with mobile manufacturing that must be understood and mitigated, as well as several challenges.

Cybersecurity

Mobile manufacturing facilities significantly increase the size and complexity of an organisation’s attack footprint. Therefore, the development of strong cybersecurity measures and protocols must be given the same level of priority as developing the technologies that make mobile manufacturing practically and economically viable.

Physical Security

There are also physical security risks that need to be understood and mitigated, as the physical attack surface will also increase as companies develop and deploy mobile manufacturing solutions. The risks from a physical attack on a mobile manufacturing facility include everything from intellectual property theft to data privacy breaches to manipulating the manufacturing process in a way that causes harm to patients.

Regulatory and GMP Compliance Challenges

Regulations governing the life sciences sector are weighted towards traditional centralised manufacturing facilities, where volume and scale are typically the priorities. Regulations, standards, and guidance will have to continue to evolve to accommodate and make viable mobile manufacturing solutions. This includes guidance on quality, inspection, and oversight.

An example of the regulatory challenges that exist includes how to ensure the ongoing compliance status of a mobile manufacturing facility when it is relocated or replicated. Another example is how an organisation’s Quality Management System can be applied to mobile manufacturing facilities.

It’s important to note that this is not a completely new area for regulators. For example, in the US, the system for people to donate blood is decentralised, with mobile blood banks inspected by the FDA every two years to ensure compliance with 21 CFR Part 606. Similar provisions exist in the EU that enable mobile blood donation facilities.

The Covid-19 pandemic also gave regulators and life science sector companies experience in completing virtual compliance inspections. Our team at SL Controls developed a virtual inspection solution that solved an immediate need during the pandemic but also has potential applications in ensuring the ongoing compliance of mobile manufacturing facilities.

Rapid Deployment and Redeployment

A key feature of successful mobile manufacturing facilities is likely to be rapid deployment and redeployment capabilities. Engineering, validation, transportation, installation, and commissioning solutions will need to be developed and refined to meet this requirement.

Skills Availability

Mass manufacturing strategies have financial advantages, but skills availability is another important consideration, especially in the life sciences sector. The availability of skills means a large percentage of production in the sector takes place within established ecosystems.

Ireland is a good example, as it has a strong life sciences sector ecosystem that includes high levels of employee skills as well as established companies that provide support services to pharmaceutical and medical device manufacturers.

With mobile manufacturing, factory-in-a-box solutions can be installed in locations with minimal skills availability. Organisations will need to develop plans to overcome this challenge by, for example, maximising automation. Training strategies might also be part of the solution.

The Potential of Mobile Manufacturing

Mobile manufacturing is not the only way to achieve decentralised production. Furthermore, decentralised production is not going to be the best strategy in all situations. What is becoming clear, however, is that innovation in the development of medicines and other treatments is placing an increased requirement for new manufacturing solutions. Mobile manufacturing is likely to have an important role to play in bringing elements of healthcare to more people faster, more efficiently, and more economically than before.

Digitalising pharmaceutical and medical device manufacturing facilities is a high priority for companies in the life sciences sector. Achieving this priority involves developing fully integrated production lines while maintaining (and improving) compliance with GxP regulations. Eliminating manual data entry is an essential requirement to reach this level of digitalisation.

The rewards of creating the fully digitalised factory of the future are great – enhanced productivity, less reliance on increasingly difficult-to-find labour, and improved competitiveness, resilience, and profitability, to name a few.

However, the digitalised life sciences sector factory of the future requires full equipment and systems integration built on a foundation of integrated data.

Why Integrated Data is Essential

Manual data entry processes restrict pharma and MedTech manufacturing facilities from realising the full potential of advanced technologies such as digital twins and artificial intelligence (AI), i.e., technologies that rely on accurate, well-structured, real-time data.

Furthermore, the science behind innovations in the pharmaceutical and medical device industries is moving at pace, and production processes need to keep up. Personalised medicines such as cell and gene therapies are a good example, as the process of manufacturing personalised medicines is far too complex to manage with manual data entry.

Why Manual Data Entry is Not Suitable for the Digitalised Factory of the Future

Manually Entered Data is Inconsistent and Unstructured

A single piece of data can be recorded in a range of different ways. Dates and times are good examples, as there are many different ways of recording a date or time. This results in inconsistencies, and it is difficult to do anything with inconsistent or unstructured data beyond its raw existence.

Manually Entered Data is Prone to Human Error

Errors in manual data entry can occur for a range of different reasons. Staff might not be properly trained, for example, or mistakes can happen because of work pressures or workload spikes. Simple typos are another problem, and ambiguous or unclear data can cause issues.

Mistakes can also occur if record keeping is not contemporaneous, i.e., where systems are not updated at the time of recording the data. Any time lag between recording the data and entering it into the system increases the risk of error.

Manually Entered Data is Subject to Bias and Can Be Contested

Operator biases, either conscious or unconscious, can corrupt data that is recorded manually. This reality combined with the inevitability of human error means all manually entered data can be contested.

Manually Entered Data Creates Bottlenecks and Restricts Productivity

Manually entering data takes time, so it can create bottlenecks on production lines as well as in quality control processes. The potential for productivity improvements is also limited when operators have to spend time manually entering data.

Manually Entering Data is Labour Intensive

Manually entering data requires resources, plus it is not a task that can be considered value-adding.

Manually Entered Data Limits Real-Time Insights

When manual data entry processes are used, it is not possible to rely on the completeness or accuracy of real-time data.

Integrated Versus Automated Data

While the elimination of manual data entry is essential for pharma and MedTech manufacturers, it is also important to highlight the difference between automated data entry and integrated data.

With automated solutions, data is collected by devices and sensors in real time. This is significantly better than manual data entry, but it is an approach that is fragmented if the various systems and equipment, including legacy systems, are not integrated.

Therefore, integrated data goes further than automated data entry as it eliminates this fragmentation.

The Transition from Manual Data to Integrated data

The transition from manual data to integrated data involves integrating equipment and systems across the organisation and beyond. This includes operational technology on the production line as well as IT systems across other departments and business units. It often also involves integration across the supply chain.

It is important that manual data entry is eliminated entirely as any manually entered data that is merged with integrated data will corrupt the wider data stream.

However, the move to fully integrated data cannot typically occur overnight. A staged process is more realistic, but controls and processes can be put in place to minimise manual data entry risks. For example, instead of an operator typing an entry into a field, they should select a pre-defined option in a drop-down.

Advances in technologies and the capabilities of modern MES platforms are presenting significant opportunities for manufacturers in the life sciences sector – opportunities to modernise, improve, and innovate. The elimination of manual data entry and replacing it with integrated data is central to success.

Cutting-edge technologies are helping manufacturers in the life sciences sector improve productivity while also addressing challenges – challenges that include skills availability, product quality consistency, production oversight, and OEE (a measure of equipment and overall production line performance). Examples of these cutting-edge solutions include Manufacturing Execution Systems, process automation solutions, and equipment systems integration solutions. Another example that doesn’t get as much attention is mixed reality.

Mixed reality technologies have a low capital investment requirement that can produce impressive results. Before looking at how mixed reality can benefit manufacturers in the life sciences sector, let’s first define what mixed reality is and the main technologies that are available.

What is Mixed Reality?

Mixed reality (MR) is the lesser-known sibling of virtual reality (VR) and augmented reality (AR). You typically use a headset with all three technologies. VR involves entering a completely virtual environment. AR, on the other hand, keeps you in the real world and overlays it with digital content. What about MR?

MR takes AR a stage further, creating a range of opportunities for life sciences manufacturers. Not only does it overlay digital content onto the real world, but it lets that digital content interact with physical objects. Users can also interact with the digital content, including moving and manipulating digital objects and holograms.

What is Microsoft HoloLens?

Microsoft HoloLens is a leading mixed reality technology that offers a range of features that bring benefits to life sciences manufacturers. For example, it recognises hand gestures to make digital objects act like physical objects. It also has built-in voice support and highly precise spatial mapping capabilities.

Plus, as HoloLens is a Microsoft product, it also seamlessly integrates with other Microsoft tools and technologies, including Power Apps, Dynamic 365 Guides, and Microsoft Teams.

Applications for Mixed Reality Technologies in Medical Device and Pharmaceutical Manufacturing

Quality vs Compliance Training

The root cause of many customer complaints and CAPAs (corrective and preventive actions) in life science manufacturing is often misdiagnosed as human error, and the corrective action is typically a retraining procedure. In many cases, however, the real root cause is inadequate competence levels. Up until recently, we did not have platforms to properly measure and monitor competence. Microsoft HoloLens, together with Microsoft Community training, creates an immersive and highly interactive training experience, making it an ideal solution for improving and monitoring the competence of resources.

These technologies are key enablers of a paradigm shift that allows the industry to move the needle away from being overly focused on compliance and back towards quality, restoring the equilibrium between these two important concepts.

Furthermore, SOP training created on Microsoft HoloLens devices ensures all staff receive the same quality of training, plus it is straightforward to keep the training up to date if the SOP changes. The technology also enables Just-in-Time Competence.

Our Parent company, NNIT, has been working with this cutting-edge technology. The NNIT Mixed reality team, headed by Kasper Kronmann Nielsen, has created a whitepaper on the Microsoft learning platform. It explains how to achieve the Dynamics 365 Guides mixed reality for regulated industries.

Remote Support

Traditionally, getting support for manufacturing equipment involved a specialist engineer travelling to your facility. At best, this could take hours and considerably longer if the engineer wasn’t in your region, country, or even continent. Remote support solutions eliminate unnecessary delays, but the quality of support can be fragmented and inconsistent. This is because of the challenge of replicating the experience of a specialist engineer actually being on-site.

Until the introduction of Microsoft HoloLens, that is. By utilising the HoloLens, a specialist engineer can see through the eyes of a technician on-site to deliver accurate instructions to resolve the problem. The engineer can even demonstrate how to carry out a task using a digital object that the on-site technician can replicate in the real world using the physical object. The process can also be recorded on the device as a knowledge asset and for training. The application that enables this functionality is called the Dynamics 365 remote assist.

Benefits of Mixed Reality Technologies for Medical Device and Pharmaceutical Manufacturers

The main benefits of mixed reality technologies for SOP training in the life sciences sector include:

• Employees enjoy immersive training experiences with realistic simulations.
• The training platform is highly interactive, so employees learn by doing. Evaluations can also be created to verify and validate that users understand the training and can improve their competency.
• The training can be completed in any location, improving the efficiency of the training process, and reducing costs.
• The training is completed in a safe and controlled way, so will not impact live production lines or processes.

For remote support applications, Microsoft HoloLens offers a range of benefits:

• Real-time support with specialist engineers that involve no unnecessary waiting or travelling.
• Reduced downtime because of the elimination of unnecessary waiting time for specialist engineers to support an equipment event.
• Support is received hands-free unlike, for example, using a phone to engage with a remote support engineer, where one hand is occupied holding the phone. The hands-free nature of mixed reality technologies means technicians receiving the support can use their hands to complete tasks and follow instructions.
• Improved quality of support as the specialist engineer can see and experience exactly what is happening with the machine or equipment.
• Reduced costs as you eliminate call-outs and related fees.

Summary

Microsoft HoloLens brings the holograms you see in science fiction movies to real life with practical applications in pharmaceutical and medical device manufacturing facilities. Whether you use this technology for remote support, training, or both, the benefits are impressive, and you can expect a rapid return on investment.

Like other companies, manufacturers in the life sciences sector faced a number of challenges during the Covid-19 pandemic. One specific and unique challenge was how to conduct a regulatory audit when people couldn’t travel and there were restrictions on who could meet, where, and when. At SL Controls, we developed and successfully implemented a digital audit solution to overcome this challenge.

We worked together with a multinational customer in the life sciences sector to develop our digital audit solution. While the solution made it possible for our client to overcome an immediate challenge, it has retained its benefits beyond the pandemic as well as having wider use cases for medical device and pharmaceutical manufacturers.

Transforming Regulatory Audits in the Life Sciences Sector

Regulatory audits in the life sciences sector are essential for product quality and patient safety. However, they are also resource-heavy, often involving upwards of 60 people. Some of those people may only be needed for a small part of the audit, but they are still needed. Traditionally, that has meant getting everyone together in the same location, from validation staff to subject matter experts to external auditors.

SL Controls co-founder and Chief Digital Architect, Shane Loughlin said: “When we were approached by our client about developing a digital audit solution, we decided to take a step back to look at what an audit process is and what it involves. When we did this, we could see that audits are, at their core, collaboration events.

“So, in developing this digital audit solution, what we were actually creating was a digital collaboration platform. It needed tweaks, adjustments, and specific features to ensure it met the standards and requirements of regulators and our customers. But it was a digital collaboration platform, nonetheless.

“We are excited by this concept as the solution has much wider use cases beyond enabling regulatory audits in pandemic situations. It has the potential to become the standard approach for regulatory audits in the life sciences sector, and it can be tailored as a digital collaboration tool for other applications.”

The Importance of Compliance When Collaborating Digitally

There are lots of digital collaboration platforms available. The difference between standard digital collaboration platforms and the solution we have developed is compliance, i.e., our solution meets the compliance requirements of auditors in Europe, the US, and elsewhere around the world.

SL Controls Compliance Director, Dermot McMorrow, said: “The big difference with our solution is that it is fully compliant on the IT security side of things. As a team, we had been thinking about this for some time before Covid-19 as we knew this was the way things were going. The pandemic acted as a catalyst, so we are now way beyond the proof-of-concept stage.

“The solution has been developed, tested, proven to be effective, and then used in multiple audits of companies in the life sciences sector.

“The results have been impressive, too. Both companies and auditors found the process at least as smooth and seamless as the traditional in-person approach, with most saying it was an improvement. There have also been considerable efficiency and cost savings, primarily through improved communication and control, and the elimination of travel.”

Secure, Compliant, and Effective Digital Collaboration in the Life Sciences Sector

In developing the new digital audit and collaboration solution, we looked for ways to automate and streamline as many of the processes as possible. Systems Engineer Blessing Nwachukwu worked on the project.

“We worked closely with our client on the development of our new digital audit solution. Automating processes was a crucial consideration, as was making the solution as seamless as possible. We also had to ensure the process was integrated into the Microsoft platform to create an effortless experience for the users. The solution can connect people from any location to participate in an audit, making it fully remote-enabled.

“Our initial thought was to host the platform on an external domain, but that created connection and accessibility difficulties. We moved instead to hosting the platform on the customer’s domain using Microsoft Teams and its suite of apps.

“After conducting tests and mock audits, we supported our customer on their first live audit. It was an HPRA audit, so the auditors were in Ireland, but everything was done remotely. The audit went smoothly, and it was successful. This led to more audits and, so far, we have successfully supported our customers in 16 different regulatory audits using our digital solution. Each one resulted in positive feedback.

“This solution and the technologies that make it possible represent an important milestone in the modernisation of the compliance processes that are so essential in the life sciences sector. At SL Controls, we are continuing to refine and expand the solution, and we are enthusiastic about its potential.”

If you would like to find out more about our digital audit solution for the life sciences sector, please get in touch with us today.