How HVAC is evolving from utility to critical quality enabler

Once viewed as a background utility, HVAC systems have become crucial to pharmaceutical manufacturing — enabling contamination control, regulatory compliance, and sustainability. With the rise of global standards like EU GMP Annex 1 (2023) and the growing push for digitalisation and energy efficiency, HVAC is no longer just about temperature and humidity control. It is now a core pillar of quality assurance and contamination risk management

HVAC is emerging as a strategic pillar in pharma quality, compliance, and sustainability

Over the past decade, the role of HVAC systems in pharmaceutical manufacturing has evolved from being a utility function to becoming a core enabler of product quality, compliance, and sustainability. This transformation has been driven by the twin forces of stricter global regulatory frameworks and rapid technological advancement.

With the revision of standards such as EU GMP Annex 1 (2023), WHO TRS updates, and US FDA guidance, the pharmaceutical industry has witnessed a paradigm shift from conventional temperature and humidity control to a risk-based contamination control approach. HVAC systems are now viewed as a vital component of the overall quality assurance strategy — ensuring environmental integrity, cross-contamination prevention, and adherence to Good Manufacturing Practices (GMP).

Over the years, innovations such as low-leakage AHUs, energy-efficient chillers, high-efficiency filtration, variable air volume systems, and smart automation have redefined performance benchmarks. The integration of IoT, data analytics, and AI-based monitoring has also enabled real-time validation, predictive maintenance, and enhanced data integrity — critical for regulatory compliance.

Throughout this period of change, ISHRAE has played a pivotal role in bridging the gap between engineering, compliance, and sustainability. Through initiatives such as Pharma Connect, ISHRAE Mumbai Chapter has created a vibrant knowledge sharing platform that brings together regulators, consultants, and manufacturers. The Society continuously supports its pharma members through technical training, advocacy initiatives, and publication of design guidelines, helping them align with evolving standards while adopting best practices.

As India strengthens its position as the pharmacy of the world, the synergy between pharma and HVAC professionals — nurtured by ISHRAE — continues to shape safer, cleaner, and more sustainable manufacturing environments.

Because in today’s pharma world, when HVAC breathes right — Pharma thrives.

Digital technologies are quietly transforming HVAC into an intelligent compliance partner

Over the last decade, HVAC standards in pharmaceutical manufacturing have undergone a quiet revolution. Earlier, design intent revolved around temperature, RH, and air changes to meet Schedule M and WHO GMP norms. Today, validation and continuous monitoring have taken centre stage. Global guidelines like EU GMP Annex 1, US FDA, and Schedule M now emphasise contamination control, data integrity, and lifecycle quality.

India’s ambition to move from “Pharmacy to the world” to “World leader in pharmacy” has intensified the need for global alignment. Tighter supply-chain scrutiny and lessons from pandemic disruptions have driven clients to demand digital traceability of every cubic metre of clean air.

With AI-enabled Building Management Systems and cloud-based monitoring becoming common, HVAC design is shifting from paperwork-driven setups to smart, responsive environments that learn from data and maintain compliance with far greater ease. Every cubic metre of clean air must now come with its own audit trail.

Technology is gradually transforming how HVAC systems are designed and operated. Sensors and digital monitoring now provide continuous data on temperature, humidity, pressure, and filter condition — helping engineers spot early warning signs.

Artificial intelligence and machine learning are still in early adoption but are beginning to analyse operational data, predict equipment faults, and suggest energy-optimisation actions. CFD modelling and digital-twin tools allow designers to visualise airflow and contamination risks before fabrication, reducing rework and validation time.

In India, the movement toward smart, connected HVAC systems has clearly begun, though much remains manual. The goal is to evolve from data collection to intelligent interpretation — where technology becomes an assistant to the engineer, not a replacement.

Cleanrooms demand strict temperature, humidity, and pressure stability — but this precision consumes enormous energy. The focus is now on reducing this load without affecting GMP compliance. Modern facilities are adopting high-efficiency chillers with magnetic-bearing compressors and strong part-load performance. Low pressure-drop filters are gaining recognition, as filter resistance alone can drain thousands of kilowatt-hours annually. Precision air-distribution and hydronic design — correct duct sizing, balanced airflows, and optimal pump heads — minimises hidden losses while maintaining uniformity.

Heat-recovery systems such as run-around coils and energyrecovery wheels are used wherever cross-contamination risks permit. AI-based analytics for energy tracking are still emerging but hold promise for the near future. The sector is learning that sustainability begins with good engineering — each Pascal of saved pressure drop and each recovered kilowatt counts toward a cleaner, more efficient plant.

The pharma HVAC sector continues to face familiar challenges — high energy cost, complex validation, microbial risks, and documentation overload. The response so far has been steady and practical. Most facilities still rely on periodic manual checks, but continuous monitoring using calibrated sensors is becoming more common, reducing human error. A few progressive plants have introduced cloud-based monitoring for validation reports, though AI and IoT remain at an early stage.

Moisture and mold control now receive stronger attention through improved psychrometric design, coil hygiene, and airbalancing practices. Upskilling maintenance and HVAC staff is another vital focus. Overall, the Indian pharma industry is moving — step by step — from reactive maintenance to preventive, data-informed operation, laying the foundation for more reliable and sustainable facilities.

As Indian pharma modernises, HVAC systems are quietly becoming smarter, cleaner, and more efficient. The transformation is evolutionary, not revolutionary — yet it is reshaping the very air that ensures product safety. The next leap will come from merging engineering rigour with digital intelligence, where every cubic metre of conditioned air supports both compliance and sustainability.

Unified standards and smarter design are key to unlocking next-generation HVAC performance 

Current HVAC design relies on a diverse, and sometimes confusing, array of guidelines issued by regulatory bodies such as WHO, EU GMP, ISO 14644, ISPE Baseline, and ASHRAE/ISHRAE. Furthermore, specific equipment has its own dedicated guidelines, including Eurovent/AHRI for Air Handling Units (AHU) and EN779, ASHRAE 52.2, and ISO 16890 for air filters.

This multiplicity of standards, particularly those governing filter testing—each with its unique methodology— can lead to designer confusion in selection and correlation. There is a pressing need for the unification of these standards, and for the outdated versions to be formally phased out to create a clearer regulatory environment.

Technology shaping the next generation of HVAC:

The era where energy consumption was secondary has passed. The future of HVAC is being driven by technologies focused on optimisation and efficiency:

◆ Artificial Intelligence (AI): AI is poised to play a crucial role in future systems by analysing actual load profiles of buildings and industrial plants, leading to the optimum selection and sizing of equipment capacity.

◆ High-efficiency equipment: Technological advancements are influencing the selection of more efficient components, such as magnetic bearing chillers and Electronically Commutated (EC) motors.

◆ Enhanced dehumidification: New solutions now achieve necessary dehumidification requirements with lower regeneration temperatures, significantly contributing to overall energy savings.

◆ Control systems: Modern chiller plant management systems and variable pumping systems equipped with inbuilt pump curve intelligence are providing superior control and system optimisation.

◆ Sustainability and Environmental Control: Recognising HVAC systems are major energy consumers, manufacturers must move from traditional rules of thumb toward optimised design parameters.

◆ Optimising air flow: The Air Changes Per Hour (ACH) is often over-designed due to the fear of non-compliance with particle count requirements. Similarly, the selection of internal conditions (temperature and relative humidity) must be optimal, as unnecessarily low RH requirements demand disproportionately high energy costs.

◆ Sustainable practices: Manufacturers are increasingly adopting Variable Air Volume (VAV) systems and Energy Recovery Systems (ERS). Retrofitting existing systems with more efficient components is a common strategy to add value without increasing capital expenditure.

Major industry challenges: To fully realise the potential of next-generation HVAC, the industry must address several significant challenges:

◆ Awareness and education: There is a critical need for mandatory education and awareness programs regarding energy efficiency and technological advancements across all segments: manufacturers, designers, and suppliers.

◆ Standards unification: As noted, the unification of diverse standards is essential to eliminate chaos and provide clear regulatory guidance.

◆ Over-design: Over-designing HVAC systems, often due to limited forecasting of product and subsequent system requirements, leads to significant operational inefficiencies.

◆ System bypassing: Even when sophisticated systems are implemented, their efficiency is often compromised or entirely bypassed due to a lack of proper training, illiteracy regarding the system’s function, or general ignorance on how to operate the smart technology correctly.

Contamination control and HVAC must evolve together through training and technology

The HVAC system is not simply a utility in a pharma facility — it is a key enabler of Contamination Control Strategy. As pharma manufacturing evolves, the HVAC design, operation and monitoring must evolve in parallel.

In the next five years, HVAC systems will become smarter, more energy efficient, more flexible, more instrumented, and more tightly integrated into contamination control frameworks. To future-proof the systems, the companies must adopt a risk-based CCS, design for flexibility/modularity, prioritise monitoring/data integration, balance compliance with sustainability, maintain rigorous qualification and lifecycle management, and build reliability and resilience into the system.

Contamination control strategy has taken giant strides in the last few years and HVAC is trying to keep up by introducing new standards. Cleanroom design was governed by thumb rules for many years and being the “Prima Donna” it was rarely questioned. It was only with the advent of ‘Energy Efficiency’ that the empirical rules were challenged.

HVAC standards have kept pace thanks to the efforts of ISO and ASHRAE. In India ISHRAE and the Contamination Control Society of India have contributed greatly to this effort. HVAC standards are being constantly updated to keep up with the new trends and this will accelerate sharply with AI leading the way. Pharma companies should have continuous ongoing training programmes to familiarise their QA,QC and operating staff with new developments and standards like EUGMP Annex 1 (2022).