To prevent contamination in biopharmaceutical products, operating procedures have to be carefully monitored throughout the development and manufacturing process. Incorporating automation and robotics into industrial microbiology workflows can help to identify and prevent contamination.
We have spoken to Valerie Wittenberg, Head of Robotics and Automation for Industrial Microbiology at Merck about the role of industrial microbiology in the biopharmaceutical industry, how automation is being applied in industrial microbiology, how it influences data integrity, and how Merck supports its customers with automated technology to identify the presence of and prevent contamination in the industrial setting.
What role does industrial microbiology play in the biopharmaceutical industry?
The role of industrial microbiology is critical in the biopharmaceutical sector. Its purpose is to monitor contamination events and oversee the development of standard operating procedures to minimize the risk of contamination.
If you look at injectable drugs, for example, contamination needs to be zero – there can’t be any bacteria in the final product – because it will be injected directly into the patients.
How is automation currently being applied to industrial microbiology?
As we incorporate more automation into industrial microbiology workflows, we expect to see improvements in processes, greater process control, and a reduction in costs from false-positive or false-negative results.
A key area we are actively working on at Merck is the automation of activities that are done repeatedly by humans. We’re trying to replace those steps with, for example, a robotic arm programmed to pick up funnels or pipettes. This has the potential to guarantee a certain level of repeatability, which, in turn, reduces errors and costs related to those errors.
Automated processes and tools can also be designed to quickly trace where potential contamination is coming from. Other applications include smart labels for tracking a crate or a bottle through a process, as well as voice activation.
How do you see the relationship between automation and data integrity?
Data integrity is a clear focus for the industry and regulatory authorities like the FDA and EMA. Data integrity means that 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 can improve data integrity by allowing more effective and timely tracing of the root cause of an issue.
Over the last few years, there’s been a strong drive from regulatory authorities to ensure the data and resulting products are validated and traced. Automation and robotics improve the ability to validate data integrity on the customer’s side.
Relying on automation and digitization 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.
An automated approach also reduces the risk from a predictability standpoint. The use of an automated approach to perform routine tasks reduces the risk of having processes done slightly differently from one day to another or from one operator to another.
How does increased data integrity help reduce risk, improve the quality of the product, and increase efficiency?
As long as you’re able to trace the root cause of an issue, you can address it before it becomes a problem on the production line. This is why it’s important to have, at any point in time, traceability of the whole test workflow – operators, sampling point, sample details, and all consumables and hardware involved in the testing – to be able to detect if there is an issue, where it comes from, and how to fix it before it becomes a bigger problem.
In industrial microbiology, manufacturers of pharmaceuticals, food, beverages, and cosmetics also need assurance that the data are correct and production steps are repeatable.
Final results will be validated because they have been monitored throughout the manufacturing process, and anything coming into or leaving the process has been checked. So you have a full record of how your product was made and the confidence to release the final product batch.
How do you support your customers’ drug development processes with automation?
We take a holistic look at the workflow, understand what the customer needs to accomplish, and then think about how automation and digitization could be applied to meet the customer’s testing objectives on a daily basis and streamline the industrial microbiology workflow.
A guiding principle is to use digital technology because it benefits our customers in terms of going paperless, enhancing traceability, and reducing risk, as well as remaining in full compliance with regulations.
For example, when we consider traceability, we consider the full ecosystem. We track and trace the entire quality control (QC) process from incoming raw materials and consumables, through the warehouse, into the labs and manufacturing areas.
We track which products and lot numbers get used at which step, in which batch, and tie those batches to the final lot release. We also track all information related to the operators involved in the QC process.
Understanding the specifics of these activities at customer sites feeds into our product development road map. Observing and working with customers in their facilities and seeing their workflows and processes, inspires ideas as to where and how we can help them speed up repetitive tasks, reduce sources of risk, and ensure enhanced traceability.
This collaborative approach ensures we develop solutions that meet our customers’ needs. For example, in reviewing a customer’s workflow, we might find that the user needs two hands for a specific process, and having voice control at that step would be beneficial – which we can then include.
If a customer is thinking about automation and digitized technology for their industrial microbiology functions, what advice would you give?
Find good partners. Starting an automation project or program is not a small activity and requires clarity regarding the objective and the problems that need to be solved. It requires strong leadership from senior management because it’s a significant investment in terms of resources, including the type of expertise and the skill sets needed, as well as finances.
Objectives for automating industrial microbiology functions can include saving money in the long term, ensuring product quality and compliance, as well as controlling the manufacturing process. Companies also want to enable faster corrective and preventive actions.
An automation project normally goes deep into how the lab or the entire organization operates. It also involves retraining the personnel involved. Implementing automation can be a significant change and, as such, it is essential to have robust management processes in place.
That is where experienced partners can help by providing the manufacturing know-how, regulatory expertise, digital and automation capabilities, and project management and implementation experience to help guide and support the client’s transition.
What does the future hold when you think about your strategic initiatives?
Our focus is on our customers and their continually evolving needs. Our approach includes understanding their process and requirements and showing them how and where automation can improve the efficiency of their QC process by reducing the risk of error, standardizing operations, and freeing their resources for non-repetitive tasks.
We help our clients determine the cost of an automated approach and the benefit of this investment. We are also building standardized solutions which will enable customers to meet their objectives in terms of testing, product quality, predictive analyses, and maintenance.
All of this is paving the way for an even better approach to industrial microbiology, as QC moves closer and closer to the production line. The future path is clear: the shift will be from today’s off-line testing in traditional QC labs, to at-line testing on the production floor, to online testing and ultimately in-line, real-time testing.
To learn more about how we can help you automate your microbiological monitoring and testing processes, contact us at erin.patton@merckgroup.com.
Images via Shutterstock.com