In Conversation with Sajeev Nadar | Managing Director – Fablab Group
Pharmaceutical facilities are some of the most rigorously engineered environments in the world, and at the core of their reliability lies the MEP system. In this conversation, a seasoned expert in Mechanical, Electrical, and Plumbing systems, Sajeev, walks us through the nuances of designing compliant, efficient, and future-ready infrastructure for pharmaceutical manufacturing.
When working with pharmaceutical facilities, how do you define the critical parameters for MEP design, especially in areas like HVAC, electrical redundancy, and water systems?
It starts with understanding that every square meter in a pharma plant is a controlled environment. The parameters aren’t just about operational efficiency, they’re tied directly to product quality and regulatory compliance.
HVAC systems, for instance, must go beyond climate control. The focus is on managing particulate levels, humidity, temperature, and pressure differentials based on cleanroom classifications, ISO 14644 or EU GMP Grades A through D. Every detail, from air change rates to filter types, is calibrated to minimize contamination risk.
On the electrical side, redundancy is absolutely essential. Dual feeders, automatic transfer switches, and UPS systems for critical loads ensure zero disruption. There’s also a growing move toward intelligent power distribution with system-level monitoring.
As for water systems, whether it’s WFI, PW, or clean steam, the design must eliminate stagnation, maintain loop velocities, and ensure sanitization. These systems are often hot recirculated and validated down to the last valve.
And in that context, how do you ensure global compliance, especially with GMP, WHO, and USFDA expectations, when designing these systems?
The key is to embed compliance into the design phase itself. It’s not something that can be layered on afterward.
Each system, be it HVAC, water, or power, is built around user requirement specifications that align with GMP principles. Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ) follow. What regulators are looking for today isn’t just functional performance, they expect traceability, validation, and control.
Take USFDA, for example. Their focus on data integrity means that monitoring systems like BMS or SCADA must be 21 CFR Part 11-compliant. WHO places a strong emphasis on hygiene, zoning, and cleanability. EU Annex 1 goes deep into airflow, cross-contamination, and environmental monitoring.
The best approach is to reference standards like ISPE Baseline Guides, GAMP 5, and PIC/S from the outset. That way, the facility is inspection-ready, by design.
How do you approach layout planning and space allocation for critical MEP systems, especially when balancing equipment density, maintainability, and regulatory zoning?
Layout is often the unsung hero of compliance and operational efficiency.
We begin by mapping functional zones based on process flow and cleanliness classification, then layer the MEP systems around them. Equipment density must be optimized without compromising airflow paths or access for maintenance.
For example, tight interstitial spaces can hinder duct routing or piping slope for drainage. So, we plan for walkable service corridors, valve access, and room for future retrofits.
Zoning is also fundamental. Dirty utility areas, clean process zones, and technical spaces must be physically and functionally separated. Even aspects like lighting, drainage, and finishes follow zoning logic to meet GMP requirements.
Contamination control is such a core issue in pharma. How do systems like HVAC zoning, filtration, and pressure differentials work together to maintain cleanroom integrity?
It’s a tightly coordinated system, and HVAC is at the heart of it.
First, there’s zoning. Cleanroom zones are classified based on risk, and airflow is designed to move from cleaner areas to less critical ones. Pressure cascades, often maintained at +15 to +30 Pascals between rooms, create a barrier against contamination migration. Interlocking airlocks reinforce this separation.
Filtration is equally critical. Systems typically include multi-stage filters, ending in terminal HEPA filters (H13 or H14) validated for ≥99.97% efficiency. These aren’t just installed and forgotten, they’re tested, certified, and monitored regularly.
The goal is to keep the environment stable and predictable. Even minor disturbances, like a door left open, can disrupt pressure hierarchies. That’s why dynamic monitoring and fast-response controls are so important in maintaining cleanroom integrity.
With that level of complexity, how do automation systems like PLCs, SCADA, and BMS fit into the picture?
They’re no longer optional, they’re essential.
PLCs handle the on-ground logic, starting and stopping fans, regulating chilled water flow, adjusting damper positions. SCADA sits on top, providing real-time visualization, alarming, and control across the facility. And then BMS brings it all together, integrating HVAC, power systems, fire safety, and environmental controls.
What’s changed in recent years is the sophistication of these platforms. They now come with built-in audit trails, alarm history, and user access controls to meet data integrity standards. Edge computing and IoT are also making their way in, allowing predictive maintenance and remote diagnostics.
Today, automation isn’t just about efficiency, it’s about compliance, reliability, and actionable insights.
Let’s talk about utilities, especially WFI, compressed air, and backup power. How should these be structured to avoid downtime in high-risk production environments?
In pharma, downtime isn’t an inconvenience, it’s a risk to product integrity and regulatory standing.
WFI systems are typically designed with hot loops, vent filters, and full drainability. Sanitization protocols, whether thermal or ozone, are built into the design. Components like diaphragm valves, orbital welds, and sloped piping ensure hygienic standards are met.
Compressed air systems are another area of focus. They’re designed oil-free, filtered down to 0.01 micron, and monitored for pressure, dew point, and contamination. Duplex compressors and ring-loop distribution add the necessary redundancy.
Backup power is layered. UPS systems protect critical instrumentation and automation, while diesel generators, with auto-transfer and synchronization, support full-load operation. Load prioritization ensures that essential systems remain unaffected even during extended outages.
Each of these utilities is integrated into central monitoring systems, so anomalies are detected before they escalate.
Looking ahead, what are some of the innovations shaping the future of pharmaceutical MEP design?
Several shifts are already underway.
Modularization is gaining serious traction, especially for cleanrooms and utility skids. Pre-engineered, factory-tested modules reduce project timelines and ease integration.
Sustainability is also front and center. High-efficiency motors, heat recovery systems, VFDs, and solar integration are no longer rare. Facilities are increasingly designed to meet LEED or IGBC benchmarks. Energy monitoring is becoming as important as environmental monitoring.
Another key area is diagnostics. IoT sensors are being embedded in systems to track vibration, flow rates, and pressure drops. The data is fed into analytics engines for predictive maintenance and system optimization. Digital twins are being used to simulate MEP performance and validate changes before implementation.
The overall shift is clear, MEP systems are evolving from passive infrastructure to intelligent, responsive, and sustainable systems that actively support product quality, regulatory compliance, and operational resilience.
