You’ve probably heard of the growing trend toward automating microbial quality control (QC), and the benefits of faster and more reliable results, easier compliance, and fewer error-prone manual tasks sounds attractive to you—but you don’t know where and how to start? Then you’re not alone: in my experience this apprehension is very common, and it’s quite understandable why. The stream of new information can be overwhelming and you need the resources to get a project done. Automated systems for routine procedures in QC are grabbing your attention, but where do regulatory compliance, financial considerations, and the impact on your staff in their daily work come into the equation?
By Anne Weeks, Automation & Robotics Specialist, Merck
My suggestion is to move forward step by step once you have assembled your team of committed stakeholders. Certain questions are sure to come up sooner or later, and I’m using them to give this article its structure:
► Who should be in the project team?
► Is external support advisable?
► Is your facility ready for QC automation?
► How will your QC personnel be affected?
► What do validation, qualification and implementation involve?
► How do you weigh the benefits against the costs?
► How pitch a convincing business case to management?
Who should be in the project team?
It is usually a particularly committed person that sets the wheel in motion. This change agent can be a validation team member, the operations director, a QC manager or whoever takes the initiative. The present function in the company doesn’t really matter much because the first step will be to set up a team that brings together the expertise needed to assess the feasibility of automation. Commitment and a shared vision to succeed seem to matter more. . The change agent will usually have gained some knowledge of automation by gathering information at conferences, speaking to colleagues, suppliers, possibly peers from other facilities or by other means.
In my experience, the facility’s willingness to embark on the path to automation is stronger when there is a problem for which a good long-term solution has not yet been found. Limited availability of skilled staff or the need to expand QC testing volumes can also be the initial drivers. Acting this way makes sense—it adds the additional benefit of putting the issue to rest. Having said that, most facilities will be looking into QC automation for one reason or another in the coming years, and starting early avoids the need to deal with it under pressure at a later date.
Among the members of the project team there should be an internal IT specialist because automation regularly goes hand-in-hand with digitalization, which multiplies the benefits of automation. Any changes in QC testing will have to be reflected in the management and evaluation of data, and the new solution must be integrated into the existing IT ecosystem. Getting that done in compliance with regulations will be one of the most important tasks, which is why an internal compliance and regulation specialist should also participate. A services specialist should also be part of the team to clarify if the capabilities and resources to service the automated equipment are available internally or if it is better to look for full coverage by the supplier. Larger companies may have a validation team or a technology & innovation group that will support or even drive the process toward automation. In a balanced project team, everyone will have a role to play.
Is external support advisable?
To ensure that the project team addresses, discusses and acts upon all the relevant issues, it makes sense to get support from outside the company right from the onset. Automation and robotics solutions are still quite new so it is probably difficult to find someone with the needed first-hand expertise and experience who is not affiliated to a supplier. Among the suppliers, those with a wide spectrum of automation and robotics solutions will usually be better placed to assess the requirements for the tasks a pharmaceuticals manufacturer may, over time, want to automate.
The tests that can, in principle, be automated include:
► Environmental monitoring
► Bioburden testing
► Sterility testing
► Sample processing, incubation, and final count
At Merck, we have specialists in these fields who have collaborated with pharmaceutical companies in actually developing such systems and who are well acquainted with both compendial and rapid QC automation methods and their validation. Their contacts can also help to get the right people together. In one recent case, I could make a facility aware that at another of the company’s sites in a different country they were having similar plans. Moving forward in tandem can save resources by avoiding to go through evaluation of automation separately. This also makes planning and validation more efficient. Suppliers who have supported their customers for many years in microbial QC are likely to have a better understanding of how regulatory compliance is achieved than integrator companies that specialize more on the robotics than the test applications.
Is your facility ready for QC automation?
Most facilities should be either ready for automation or convertible. There might have to be a new space created that is automation or robotic “friendly” or a modified space as automation usually takes up somewhat more room than the corresponding manual methods. Requirements differ considerably depending on the application. While some automated systems are fixed to one place over their entire lifetime, others such as EM robots move between sampling locations, either regularly or at intervals.
Moving robots, like the ones we are developing for environmental monitoring, require:
► Level flooring with no slopes or steps
► Corridors dimensioned to allow robot movement
► Sufficiently sized elevators If the facility covers multiple levels
► Doors that open and close automatically
► Large enough locks with no physical obstacles to overcome
Constructing a new manufacturing facility makes the adoption of automation easier because operation does not need to be halted during conversion. Future requirements in an industry with constantly rising regulatory demands can be also taken into account from the onset, leaving more options.
How will your QC personnel be affected?
To many employees, automation carries the risk of redundancies—understandably so because this has been the consequence in some other sectors, for example the car industry. However, in microbial QC, reducing staff levels is rarely the primary goal, or even realistic. Given the constantly increasing QC testing volumes, particularly for biologics and advanced therapies, the real objective is to use the existing expertise more effectively. QC departments are already struggling to attract, maintain and train the personnel they need.
Automation can free up staff hours for higher-value activities like:
► Data interpretation
► Method development
► Root-cause investigations
It helps to create a more engaged workforce. Many facilities are already contending with a limited availability of skilled personnel while a substantial share of staff time is being spent on repetitive manual tasks such as plate preparation, sample transfers, incubation management and documentation. This is why a key early role of the project team, apart from setting the path to automation, should be to dispel concerns among the QC personnel about job losses. Routinely operating the automated systems shouldn’t become much of an issue either. Reputable suppliers mostly offer hands-on training courses for personnel along with the automation systems they offer.
Some tests don’t lend themselves well to physical automation due to the very different protocols and consumables used, for example sterility testing. However, configurable software guidance at the point of handling to support operators to follow SOPs can carry many of the same benefits of automation. Our M-Trace® solution for sterility testing, for example, builds on step-by-step verbal or screen-displayed instructions and, when each step is completed, feedback from the operator, combined with simultaneous real-time data capture. This significantly lowers the risk of handling errors while ensuring data integrity and traceability.
A few things will continue to be done conventionally. It’s important that manufacturers maintain the capability among their staff to perform manual testing for when maintenance is performed on the automated system as well as for validation and revalidation purposes, given that they constantly have to deal with new matrices. So it’s not either manual or automated testing—they complement each other.
What do validation, qualification and implementation involve?
A common misconception about QC automation is that regulators won’t like it because it’s unconventional. In fact, the opposite is true. Regulation is gradually evolving to make automation not just possible—it has started to promote such technologies. Automated systems operate with consistent precision and repeatability, which reduces the risks of cross-contamination and human errors. This leads to more robust test results and fewer false positives, improving both reliability and efficiency. The comprehensive data that is automatically captured can be analyzed to detect trends and deviations early, accelerating investigations into out-of-specification results.
Automation and robotics, in combination with digitalization, also
► Improve data integrity and audit readiness
► Reduce the risk of investigations becoming necessary
► Provide the ability to better fulfill future regulatory requirements such as electronic records or advanced analytics
In a nutshell, automation comes with digitalization as both an enabler and an amplifier of efficiency and reliability gains. Expect regulators to know about the potential to improve compliance. If in doubt about anything, it should be possible to discuss this with them.
Suppliers should be able to provide documentation and services to support validation, qualification and implementation of their automated systems. This eases the burden for the pharmaceutical manufacturer significantly. The Growth Direct® System, for example, has been validated in as little as three months. The time this takes depends primarily on how the system is used and on the resources the company is able to make available.
How do you weigh the benefits against the costs?
In practice, discussions about return on investment (ROI) and payback periods often start with an all-too-narrow focus on direct labor cost savings. Maybe it is intuitive to assume that the overriding purpose of automating repetitive tasks like plate handling, air sampling, or incubation is to reduce the need for manual activities and documentation. But in reality, there is far more to it.
A more meaningful approach is to view ROI in terms of the total cost of quality. While many benefits are difficult to quantify, ignoring them leaves you with a wholly incomplete calculation. From a business perspective, it’s more meaningful to distinguish between two types of benefits. At operational level they include direct savings and capacity gains, for example due to reduced overtime, the ability to handle higher sample volumes without proportional increases in headcount, and the elimination of manual testing steps. Because these can be translated into tangible metrics, they form the quantitative foundation of most business cases.
The second type consists of strategic benefits, including:
► Greater throughput flexibility
► Better data integrity and audit readiness
► Easier design and execution of contamination control strategies
► Reduced risk of costly issues like deviations, rework, valuable product going to waste, and interventions by regulatory bodies
► Easier compliance when regulatory requirements increase or change
► Improved attractiveness of the QC lab for existing and new personnel
Automation can deliver value across all of these areas, at various levels, not just through labor efficiency. Robotic and automation systems operate tirelessly and with precision, and their standardized motions are exactly the same, day in, day out. Facilities that offer the flexibility to operate seven days a week and for long hours, or even 24/7, have the competitive edge in a faster moving market where demand fluctuates.
How pitch a convincing business case to management?
While the benefits of automation are widely recognized, the real challenge often lies in securing investment. Automation of microbial QC competes with other projects for both funding and attention, which is why the project team needs to clearly articulate its value to management. This means presenting a structured case that links the total cost of ownership to tangible value drivers and aligns with the financial and operational criteria used by the manufacturing and finance stakeholders.
While strategic benefits are harder to quantify, they are highly relevant at corporate level, where longer-term considerations, brand reputation, and improbable but potentially severely damaging events are weighed alongside short-term financial returns. Taking all types of advantages into account allows investments in microbial QC automation to be assessed on an equal footing with more traditional manufacturing investment cases.
Conclusion
Robotics and automation, paired with digitalization, carry a huge potential for microbial QC in the pharmaceutical industry. Throughput becomes more flexible, manual handling errors are avoided, and results become repeatable and thus more reliable. The real-time captured data provide actionable insights: trends can be monitored, deviations flagged earlier, and investigations into out-of-specification results accelerated. Scheduling is streamlined, documentation burdens reduced, and overall operational efficiency enhanced. Automated data recording and storage across the entire workflow—from material selection to final reporting—ensures full data integrity and traceability.
The first step on the path to automation is usually to set up a team that looks into the feasibility of the transition. This team should include IT and regulation specialists, as well as an external expert with first-hand knowledge of and experience with automation solutions. Their role is to weigh the investment against the calculable as well as the strategic benefits. If deemed beneficial, they will be in a good position to make the case to management.
CTA: Get in touch with a specialist of ours for QC robotics, automation and digitalization: Request consultation
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