As we move toward Industry 4.0, automation, and digitalization technologies are being increasingly incorporated into industrial microbiology workflows. While increased productivity, consistency and process control can be achieved, perhaps the most important benefit will be greater assurance of data integrity, which is a focus of the biopharmaceutical industry and regulatory authorities including the FDA and EMA.
Industrial microbiology is a critical function in the biopharmaceutical sector as its purpose is to monitor for contamination events and inform development of standard operating procedures to minimize the risk of contamination. As the industry makes the shift to digitalized labs, you will see more automation, digitalization and informatics incorporated into industrial microbiology workflows, the result will be reduced error rates, increased productivity, greater process control, better traceability and cost reduction stemming from reduced manual steps and optimization of personnel, equipment and material workflows.
At a very high level, the goal is to ensure product safety, verify process performance, increase batch success rates, and accelerate QC assessment - all while reducing manual errors, interventions, variability, and resource requirements. While these opportunities continue to be explored by the industry as part of the shift to Industry 4.0, the unprecedented speed of vaccine and drug development resulting from the SAR-CoV-2 pandemic has put additional pressure on the quality control function, which has at times been a bottleneck, to evolve and accelerate to enable faster batch release and patient access.
The ultimate goal is for production testing to occur in-line and in real-time. Given its significant potential benefits, it’s expected that there will be more investment near term in automation and digitally enabled workflows that support rapid product release.
A relatively simple example of how automation can reduce risk of error and increase productivity is one that takes repetitive activities requiring human intervention and replaces them with a programmable robotic arm, such as the process used to pick up funnels or pipettes. Automating steps that reduce manual sample preparation and handling has the potential to improve lab productivity and ensure a certain level of repeatability - which reduces risk of error and costs related to deviations and subsequent investigations. In addition to automation, access to real-time data resides at the core of the lab of the future, supporting verification of products and results, optimizing schedules, reducing error rates, and trending performance to improve quality, consistency, and productivity.
It is not enough, however, to simply consider automation and digitalization from an individual product or process perspective; the view must encompass the entire process or workflow and ensure full traceability and seamless data integration. Thus, understanding the process workflow, interdependencies and data intersections is an important first step in making the shift to digitalized and automated labs. Close examination of a workflow might reveal, for example, that a user needs two hands for a process and in this scenario, voice control could offer a benefit.
As a starting point, it is essential to apply a holistic look at the workflow, understand the key objectives and then think about how automation and digitalization could be applied so that enhances the workflow. A key benefit to automation and digital technology is also its contribution to sustainability measures, enabling going paperless, and improving traceability, data security and product quality.
Impact on Data Integrity
Perhaps the most important benefit of automated, digitalized processes will be in ensuring data integrity, which is a focus of the biopharmaceutical industry and regulatory authorities including the FDA and EMA. Data integrity means that the data, the results of an analysis, or the way the analysis is conducted, cannot be manipulated. Importantly, it must be proven that data has integrity and has not been altered. Automation and robotics improve the ability to validate data integrity on the customer’s side.
Relying on automation and digitalization is a new proof of trust for regulatory authorities. The full end-to-end chain, provided by a superior system, offers assurance that there is no alteration of data throughout the process, and further proves the quality of the resulting product for enhanced patient safety.
Over the last few years, there’s also been a strong drive from regulatory authorities to ensure the data and resulting products are validated and traced. Automation and digitalization enable traceability of the equipment and consumables used in the production line and can monitor its performance. These technologies can provide a complete record and a full account of how the product is being made and ensures that it is produced within the acceptable range for the final product. This reduces risk from a predictability standpoint.
Further, automation and robotics can enable more effective and timely tracing of the root cause of an issue. The ability to detect a potential problem and trace where it comes from enables it to be addressed before it becomes a bigger problem – thereby ensuring the quality and consistency of the product and increasing process efficiency.
Users also need assurance that the data are correct and repeatable. Results must be validated and well-documented throughout the process. Users need to be able to monitor whatever has been coming into or leaving the process and have access to the full record of how the product is being made, and proof that it remains within the acceptable norms for the final product. Use of an automated approach to perform these routine tasks also reduces the risk of having things done even slightly differently one day over the other or from one operator to another.
To get started on the journey towards automation and digitalization, a company should take a holistic view of their workflows as noted above, understand the project goals, and then consider how these technologies could be applied to enhance performance. It is important to keep in mind that digital does not constitute a strategy on its own, but rather, it is part of a larger movement within manufacturing – often referred to as “Industry 4.0”, the cornerstone for the facility of the future.
Patience and good partners are needed. Automation and digitalization projects are a significant undertaking and require absolute clarity as to the project’s objective and the problems that need to be solved. These projects are a significant investment in terms of people and financial resources and rely on strong ownership and sponsorship from senior management as they are deeply integrated into the way the lab and the organization operate. Automation and digitalization can represent a substantial change in the way employees operate on a daily basis and as such, it is essential to have robust change management processes in place.
The Way Forward
No doubt, automated and digitalized technologies will have a profound impact on industrial microbiology. From improved data integrity to process improvement, greater process control and reductions in variability, errors and ultimately, lead-times - the benefits will be significant. Automation and digitalization also provide more flexibility in terms of remotely verifying process performance and results and can help to make the shift towards continuous in-line testing.
We believe it is incumbent upon suppliers and manufacturers, like our organization, to help drive change and engage with our customers on an entirely new level. As innovative technologies such as the Internet of Things, cloud computing, big data, and artificial intelligence become more embedded in our workplaces, the discussion must now evolve to include the information technology (IT) function in more proactive manner. We help customers step through the process – starting by understanding how they share data and where it resides. Does it sit in a cloud? Where does that cloud sit? Our discussion not only focuses on products used in the lab and how they can make processes more efficient and reliable, but also includes IT and a data risk management perspective. The conversation encompasses IT and engineering in addition to strong understanding of the objectives, workflows and data intersections required.
Our goal is to always remain highly focused on our customers, their needs and how we can help them achieve their goals. Our approach to customers includes defining their business case and showing them potential weak points from a microbiological and regulatory standpoint. This approach helps us jointly define key aspects and requirements for an effective and efficient automated and digitalized solution that’s customized to their needs, workflow, and processes. We are also building standard solutions which will also enable customers to meet their objectives in terms of testing, product quality and being able to perform predictive analyses and predictive maintenance. All of this is enabling us to move towards the vision of Industry 4.0 and pave the way for a better, automated, and digitalized approach to industrial microbiology.