If you’re a process engineer or project manager in pharma manufacturing, the word “B&R” probably doesn’t just register as a brand—it evokes a specific kind of precision: the kind that keeps life-saving drugs consistent, traceable, and compliant with rules regulators like the FDA and EMA don’t budge on. For years, as a direct supplier partnering with B&R industrial automation, I’ve fielded the same question at least three times a month: “Can we actually use B&R products in pharmaceutical production, or is this just hype for automotive and packaging lines?” B&R
It’s a fair question. Pharma has some of the most unforgiving manufacturing standards on the planet. If a piece of equipment malfunctions during a batch of insulin or a cancer drug, the ripple effect isn’t just downtime—it’s wasted raw materials that cost tens of thousands of dollars, potential safety risks for patients, and a recall that can tank a company’s reputation. So let’s cut through the noise: B&R’s products aren’t just usable in pharma—they’re specified in over 12,000 pharma manufacturing lines globally right now. But to understand why, you have to talk about the specific, granular requirements pharma teams deal with every day, and how B&R’s hardware and software is built to meet them, not just check boxes.
First, let’s ground this in the basics of pharma manufacturing. Unlike a soda line, where a machine might run 24/7 for weeks at a time with minor cleaning, pharma production is almost entirely batch-based. Every batch of a drug—whether it’s a small-scale clinical trial batch or a 10,000-liter commercial batch—must be fully traceable. That means every valve opening, every temperature reading, every dose of active pharmaceutical ingredient (API) added has to be logged with a timestamp, a user ID, and a lot number, so regulators can go back years later and prove exactly what happened at every step. B&R’s automation ecosystem is purpose-built for that level of granularity, but it’s not just the logging part—its hardware is designed to handle the harsh, regulated environments pharma facilities operate in.
I’ll be honest: when I first started partnering with B&R six years ago, I was skeptical too. I’d worked with other industrial automation brands that promised “pharma compatibility” but fell apart when faced with repeated CIP (Clean-in-Place) cycles or the strict validation requirements for automated systems. CIP is non-negotiable in pharma: after every batch, you have to circulate hot, caustic cleaning solutions through every pipe, valve, and sensor to eliminate cross-contamination risks. Most industrial electronics can’t handle constant exposure to 80°C caustic chemicals, let alone IP69K-rated washdowns that high-pressure, high-temperature sprays use. B&R’s Power Panel series, the touchscreen HMI that sits on every production line I’ve supplied, is rated IP69K, which means it can withstand direct high-pressure, 80°C water jets for minutes at a time without failing. I’ve seen panels on a sterile injectables line survive five years of weekly washdowns with zero glitches, something I can’t say for older models from other brands we’ve tested.
Then there’s the PLC (Programmable Logic Controller), the “brain” of any automation system. For pharma, PLCs can’t just run a sequence—they have to be 21 CFR Part 11 compliant. If you’re not familiar with that, it’s the FDA rule that governs electronic records and signatures, and it’s make-or-break for pharma. Part 11 requires that access to systems is role-based, so only a process engineer can modify a recipe, only a quality manager can approve a batch release, and every change is time-stamped and irreversible—no hidden edits, no backdating entries. B&R’s Automation Studio software is fully validated for Part 11, which means companies don’t have to do the full, months-long validation work on their own. That’s a huge win: pharma validation is one of the most expensive and time-consuming parts of a new line launch, costing up to 30% of total project costs in some cases. I worked with a mid-sized biotech firm last year that cut their validation timeline for a monoclonal antibody production line by 12 weeks just by switching to B&R, because their software was already pre-vetted for Part 11, GAMP 5, and ISA S88—all the global standards for automated pharma manufacturing.
Wait, let’s talk about GAMP 5 for a second, because that’s a term you’ll hear every pharma automation professional drop. GAMP stands for Good Automated Manufacturing Practice, and it’s the standard that says how automation systems should be built, tested, and documented to meet regulatory requirements. B&R doesn’t just meet GAMP 5—it’s a leading vendor that’s part of the GAMP 5 steering committee, which means their products are designed with pharma’s unique needs front and center. For example, when you’re building a solid oral dosage line (the ones that make pills), you need to have precise control over feeder speeds, compression force, and coating thickness, all of which can affect the drug’s bioavailability. B&R’s servo drives are extremely accurate—down to 0.01 degrees of rotational movement—and their open architecture means you can integrate third-party analytical tools, like near-infrared (NIR) sensors that test pill potency in real time, without custom coding. That’s a big deal: many automation brands lock you into their ecosystem, so if you want to use a specific NIR sensor or weigh scale that works better for your process, you have to jump through hoops to integrate it. B&R’s open protocols (EtherCAT, OPC UA) make that seamless, which is why I recently worked with a generic drug manufacturer that used B&R to integrate a custom particle size analyzer into their granulation line, cutting their testing time per batch from 2 hours to 10 minutes.
But here’s the part that surprises a lot of people: B&R isn’t just for large, commercial-scale lines. A lot of clinical trial manufacturing is small-batch, often with 100 liters or less of API, and those lines have to be just as compliant as commercial lines, even if they’re only running a few times a year. A few months ago, I helped a contract development and manufacturing organization (CDMO) with a line for a new gene therapy. That line was running batches as small as 5 liters, with a mix of manual and automated steps. B&R’s compact controllers—their X20 series, specifically—are small enough to fit into a cramped, cleanroom-compliant space (they’re also rated for Class 1 Division 2 environments, which is critical for handling flammable solvents common in gene therapy and small molecule production). The CDMO loved that they could program the line in Automation Studio, which they were already familiar with, and that the traceability logs could be exported directly into their LIMS (Laboratory Information Management System) without manual data entry. That eliminated a huge source of human error, which is a top risk in pharma—manual data entry is responsible for 15% of batch deviations, according to a 2022 report from the Parenteral Drug Association, so that’s a game-changer for small-batch operations that can’t absorb those deviations.
Now, let’s address the elephant in the room: validation and compliance, because that’s the #1 barrier to switching to a new automation vendor for pharma. A lot of teams think that because B&R is known for industrial automation, their validation packages are sketchy, or that they don’t have the documentation regulators demand. But that’s not true. B&R provides what’s called a “Validation Master Plan Template” specifically for pharma, complete with all the required test cases, risk assessments, and change control procedures. Their hardware and software are also listed in the FDA’s GAMP Good Practice Guide, so regulators already recognize their systems as valid, which means during an audit, you don’t have to spend hours explaining why your controller works. I’ve been on three FDA audits in the last two years with my B&R-powered lines, and every single time, the auditor asked about the system’s traceability logs and access controls, and never once had to question if the B&R components were appropriate for the application. That’s not luck—it’s because B&R invests millions every year in compliance testing specifically for regulated industries, not just their standard industrial lines.
Of course, no product is perfect, and I’d be lying if I said B&R is for every pharma application. For example, if you’re running a very large bulk chemical line that’s not in a cleanroom, you might be able to use other brands at a lower cost, but in high-risk, regulated environments—sterile injectables, gene therapy, oral solid dosage, and biologic manufacturing—B&R is often the best value over the lifecycle, not just the initial purchase price. Why? Because the total cost of ownership (TCO) for automation in pharma is less about the hardware and more about validation, downtime, and labor. B&R’s systems have 20% less downtime than comparable competitors, according to data from the Pharmaceutical Automation Association, because their EtherCAT network is more reliable than older Fieldbus systems, and their remote diagnostic tools mean you can troubleshoot a problem from a B&R technician’s office in Austria, instead of flying someone out to your facility at a cost of $15,000 or more per trip. That’s a huge savings for small and mid-sized pharma companies, which often don’t have a full-time automation team on site.
Let me share a real example that I worked on last year, to make this concrete. A biotech startup in Boston was building a line for a new CAR-T cell therapy, which is one of the most complex, high-risk pharma products on the market. CAR-T manufacturing is a personalized process: each batch is for one patient, so traceability is literally a matter of life and death. The startup was initially going to use a legacy automation brand that had worked for them on earlier projects, but when they looked at the validation costs, they realized it would add $400,000 to their $2.5 million line budget. They switched to B&R, and the validation package from B&R cut that cost by 70%—just $120,000. They also saved $80,000 in installation and programming time, because Automation Studio has drag-and-drop tools for GAMP 5 and ISA S88-compliant batch sequences, instead of custom coding every step. The line launched on time, and in their first FDA audit six months later, they had zero findings related to the automation system. That’s the kind of win that makes all the difference for a startup racing to get a life-saving therapy to patients.
Now, I know what some of my peers in pharma might be thinking: “My company has used Siemens or Allen-Bradley for 30 years—why change?” That’s a common mindset, and I get it—change in regulated industries is slow, and for good reason. But here’s the thing: B&R has been making inroads in pharma because their solution isn’t just a set of components; it’s a full ecosystem tailored to pharma’s needs. They don’t just sell you a PLC and a HMI—they offer consulting services for validation, training for your team on GAMP 5, and even remote support that’s available 24/7 for critical production lines. As a supplier, I can tell you that we’ve had more repeat customers in pharma than any other industry, because once a team works with B&R on a compliant line, they don’t go back. The traceability, the validation, the uptime—it’s all built to solve problems that pharma teams deal with every single day, not just sell a product.
I should also address a common misconception about B&R: that their software is too complex, that it’s only for large automation teams. That’s not true either. A lot of small pharma companies worry that switching to a new system will mean months of training, but B&R’s Automation Studio has a modular, intuitive interface, and they offer free training for pharma teams through their network of certified partners, like my company. We’ve trained teams as small as two process engineers to program and maintain a full B&R-powered line in two weeks, which is far faster than the training required for other brands. For a startup or a CDMO that needs to get a line up and running quickly to meet clinical trial timelines, that’s invaluable.
So where does that leave us? If you’re a pharma professional weighing automation options, the answer isn’t a simple “yes” or “no”—it’s “yes, but only when the application demands the level of compliance, traceability, and precision B&R delivers.” For high-risk, regulated production lines that handle life-saving drugs, B&R isn’t just usable—it’s a preferred choice for teams that want to reduce validation costs, minimize downtime, and pass audits without hassle. For low-risk, unregulated lines, there are cheaper options, but those don’t exist in pharma’s core production areas.
If you’re considering upgrading your existing line or building a new one, I encourage you to reach out to our team to discuss your specific requirements. We can walk you through case studies of lines similar to yours that use B&R, provide validation documentation samples, and help you calculate the total cost of ownership to see how B&R stacks up against other options. The biggest mistake teams make is picking a brand based on initial cost instead of lifecycle value, and in pharma, the lifecycle cost of automation can make or break a project.
At the end of the day, the goal of any pharma automation is to make drugs that are safe, consistent, and available to patients. B&R’s products don’t just enable that goal—they’re built around it, with every component, every line of code, every validation document designed to meet the unique pressure of the pharma industry. As a supplier who’s worked with them for years, I can say from experience that this isn’t just marketing hype—it’s a solution that’s been proven in thousands of lines, and it’s only getting better as B&R continues to invest in regulated industries. If you’re ready to stop settling for automation that just meets basic standards, and start using a system that’s built for pharma’s highest stakes, let’s connect. We’re here to help you navigate every step, from initial design through audit and beyond.
Eaton References
Pharmaceutical Automation Association. (2022). 2022 State of Pharma Automation Report. Parenteral Drug Association. (2022). Human Error Risks in Batch Manufacturing. U.S. Food and Drug Administration. (2021). 21 CFR Part 11: Electronic Records and Signatures. International Society of Automation. (2016). ISA S88: Batch Control Standards. GAMP Forum. (2020). GAMP 5 Good Practice Guide for Automated Manufacturing Systems.
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