In pharmaceutical manufacturing, most people expect the biggest challenges to center around regulatory compliance, product development, or quality assurance. But anyone managing day-to-day operations knows the truth: equipment and facility reliability are what truly tests a plant’s resilience.
It’s not a matter of poor design or bad planning. Pharma systems are often built with precision and care. The challenge lies in maintaining uptime, flexibility, and GMP compliance—all at once—within environments that are increasingly complex and resource-constrained.
Skip Ahead:
- What is pharma missing?
- Pharma’s flawed response to downtime
- The solution to improving equipment & facility reliability
- A smarter path forward
- Case Study – Solving a Persistent Depyrogenation Tunnel Failure
What is pharma missing?
Just one failed compressor or stuck valve can stop production and set off a chain reaction of deviations, CAPAs, risk assessments, rework, and sometimes batch loss. Maintaining uptime and resolving unexpected issues quickly is a constant challenge for drug manufacturers.
Advancing technology always comes with a few bumps in the road, and a big part of running any business is putting out fires on the floor, especially the operational floor. But most major delays in pharmaceutical manufacturing can be traced back to a few core people problems:
Lack of Skilled Engineers
The scarcity of skilled technicians and engineering support is particularly acute in the pharmaceutical sector. While trade schools and college programs aim to fill this gap, most curriculum remain generic, focusing on HVAC or general engineering. The closest fit, chemical engineering, often fails to prepare graduates for the specialized equipment and facility demands of modern pharma manufacturing
The range of technical needs in pharma is vast. Expertise is required across HVAC systems, automation, clean utilities, and packaging equipment. Specialized roles such as controls engineers and steam system technicians are hard to find and even harder to retain.
Engineering needs in pharma are diverse and growing, and one of the most urgent gaps right now is in controls engineering. Demand for controls engineers has surged as equipment increasingly incorporates cloud technologies, robotics, and advanced automation. But, finding qualified talent is getting harder, especially due to a widening experience gap. Like doctors, technicians and engineers improve significantly with hands-on practice and experience. And with many seasoned professionals nearing retirement, companies are facing a looming talent shortage.
Insufficient OEM Support
Many original equipment manufacturers (OEMs) lack adequate local support, especially in North America, and their customers may only have a few trained technicians to help with routine and emergency service requests.
OEMs prioritize designing and selling custom equipment over service, and many are based overseas, causing delays to get technicians out to customer sites in North America. Site visits can take months to schedule, and preventive maintenance often requires 6–12 months’ notice.
To fill the growing support gap, some manufacturers are outsourcing technical support to engineers based in countries like India, Mexico, or China. While this approach is more cost-effective, it can create new challenges, such as language barriers and time zone differences between the OEM, the service provider, and the client. These challenges can lead to further delays, especially when diagnosing complex equipment issues.
Operational Fatigue and Turnover
Constant firefighting wears people down. Engineers and operators often leave not because they dislike the work, but because the system feels unsustainable. When every day brings new chaos, and the same problems resurface without resolution, fatigue sets in. And with fatigue comes turnover.
Pharma’s flawed response to downtime
When a critical piece of equipment breaks down, the effects ripple through the entire production chain. Operators who were scheduled to work suddenly have nothing to do. The plant, which continues to bear the cost of staffing and operations, now loses revenue. Project managers are forced to reshuffle schedules, trying to rebook production slots that were already allocated months (or even years) in advance. At CDMO facilities, clients grow anxious, especially in pharma, where drug production delays are not just inconvenient, they’re potentially life-threatening. Patients can’t afford to wait.
Equipment failures impact far more than timelines. They can affect employee morale, revenue, retention, and patient safety.
Many companies take an expensive approach to avoid downtime: expanding capacity just to offset losses elsewhere. In this way, “scaling” becomes a survival tactic, not a growth strategy. And scaling brings more challenges, more equipment issues, and more work to an already stressed engineering team.
Many companies also rely on quick fixes, making on-the-fly adjustments just to keep operations moving. But without the time or manpower to address root causes, long-term reliability suffers. The same errors and issues repeat themselves, distracting and frustrated the teams involved in constantly fixing them. Most companies know their equipment and facilities need improvement, but they don’t have the team or the time to figure out the root cause, especially when solving it could take days or weeks.
The solution to improving equipment & facility reliability
Quick fixes may keep operations running, but long-term reliability comes from addressing the right problems the right way. Here’s how organizations can take a more effective approach to equipment and facility reliability:
Support that goes beyond installation
A chain is only as strong as its weakest link, and a high-tech production line is only as good as the team that supports it. Yet, many OEMs don’t provide robust field support after installation, leaving facilities to troubleshoot on their own. What’s often missing is a dedicated team with hands-on experience. Experience engineers can quickly assess, diagnose, and resolve problems that would take less experienced teams days to work through.
Digital systems need a different kind of expertise
Pharmaceutical manufacturing equipment is becoming more software-driven which is driving new challenges to emerge. A production line doesn’t have to physically break to cause downtime. Errors in programming, automation logic, or equipment integration can bring operations to a halt. Yet many engineers in pharma haven’t worked extensively with these digital platforms. Industries like food and energy, which adopted automation earlier, have a deep bench of experienced controls engineers. Drawing from that talent pool offers pharma access to expertise that can bridge the digital skills gap and restore operations more quickly.
Solving the root cause, not just the symptoms
Lasting reliability comes from addressing underlying issues. With the right support, teams can go beyond emergency repairs to implement predictive maintenance, smarter automation, and better system integration. Increasing output doesn’t always require new equipment. Often, it’s about making existing systems run more efficiently and reliably.
A smarter path forward
We don’t have to reinvent the wheel to improve equipment reliability in pharma. We just need the right people, the right experience, and the right support model. PharmaPhixx was built to meet that need. By combining deep field expertise, cross-industry knowledge, and a focus on long-term solutions, we help manufacturers move from reactive to resilient.
Case Study:
Solving a Persistent Depyrogenation Tunnel Failure
A clear example of how these challenges show up in real life came through a depyrogenation tunnel issue encountered at a sterile fill/finish facility.
The site was experiencing reoccurring failures in a depyrogenation tunnel used to sterilize glass vials before filling. The OEM could not provide a timely diagnosis, and internal teams were locked in a cycle of reactive fixes, without a clear root cause. The issue threatened both product integrity and batch release timelines.
What made the problem difficult to resolve:
- The tunnel was fully integrated with upstream and downstream equipment, limiting access for inspection and testing.
- The tunnel’s control software did not offer meaningful diagnostics.
- Equipment schematics were outdated, and design tolerances were not clearly defined.
PharmaPhixx sent their top controls specialist to troubleshoot the error. He quickly recognized that the sampling rate was low. After increasing it and running a test cycle, a new pattern (and the issue) revealed itself. The solution was clear. The ambient air inlet damper was manually adjusted, the PID controller was fine-tuned, and the fan was reconfigured to operate within its ideal range. Once corrected, the system returned to validated state, with updated procedures in place to ensure early detection of similar future issues.
What this shows: Certain problems can be hard to spot internally, but a specialized perspective can help resolve them faster.
If you are looking to for expert engineering support, reach out to PharmaPhixx today!
