Pharmaceutical manufacturers operate in one of the most heavily regulated industries, where water quality directly affects product safety, batch integrity and regulatory compliance. Every facility must carefully evaluate where operational risks lie, from microbial contamination that can ruin expensive batches to energy-intensive utilities whose cost has skyrocketed in some regions over recent years.
The stakes are particularly high because steam-heated water purification can account for 25-50% of on-site natural gas consumption, according to studies performed at facilities in Australia and the U.S., making distillation processes a fossil-energy-intensive cost and emission center and a compliance imperative. Pharmaceutical manufacturing demands two distinct water qualities: purified water for orally administered medications and water for injection (WFI), like vaccines and IV solutions. WFI accounted for 79% of the pharmaceutical water market in 2023, according to the most recent estimates, reflecting the industry's heavy reliance on this highest-purity grade.
The regulatory landscape has evolved to enable more efficient production methods. Following the European Pharmacopoeia’s 2017 decision to allow membrane-based cold WFI production and China's October 2024 approval, all major pharmaceutical markets now accept cold WFI systems as equivalent to traditional distillation. This shift enables facilities to meet quality requirements while addressing operating cost pressures and sustainability targets that have become increasingly central to corporate strategies.
Integrated solution for energy-efficient purified water and cold WFI
Veolia’s Orion™ system provides purpose-built pharmaceutical water production through an integrated approach combining reverse osmosis (RO), electrodeionization (EDI) and ultrafiltration. The system produces both purified water and cold WFI from a single platform, eliminating the need for separate generation equipment.
The design prioritizes microbial control throughout. Hot water sanitization (HWS) extends across the entire system — pretreatment, RO, EDI and distribution loops. Frequent HWS mitigates contamination risks that can compromise batch quality. For a safer, heat-free solution to controlling microbial contamination in storage tanks and distribution loops, ozone sanitization systems provide higher energy efficiency, lower downtime and extended cycle runs because they are electricity-driven and operating at ambient temperatures. For facilities preferring hot distribution loops similar to traditional distillation systems, Orion can provide elevated temperatures for the distribution loop while still delivering substantial energy savings over phase-change processes.
Traditional distillation with a hot distribution loop requires approximately 2,200 kilojoules to change one kilogram of water from liquid to steam. Cold WFI systems heating water from 15-85°C (Δ 75℃) require only 315 kilojoules. Facilities running hot distribution loops still save roughly two-thirds of the energy compared to distillation, while those operating cold loops achieve even greater efficiency.
Addressing water efficiency
Beyond energy efficiency, water consumption is also a major concern in purification processes. The Association for Clean and Parenteral Products estimates they account for up to 20% of the pharmaceutical industry's water consumption, making water purification both energy and water intensive. Built-in sustainability features address these water-related utility costs pharmaceutical manufacturers face. The recovery RO system cuts waste discharge by 50%, reducing drain flow from the typical 25% to 12.5%. During recirculation periods when production pauses, an integrated cooling heat exchanger eliminates the 10% water waste that conventional systems discharge to manage heat buildup. These features directly address operational costs in an industry where facilities can consume double or triple the energy of typical commercial buildings.
Orion’s design reflects pharmaceutical validation requirements from the ground up. Every component meets GMP, GAMP, ASME, BPE and ISPE guidelines as well as USP and European Pharmacopoeia standards. The validation process — where design specifications, build quality and operational performance must be documented at every step — is built into Orion’s manufacturing approach rather than added retroactively. This matters in an industry where regulatory inspections scrutinize documentation as closely as water quality test results.
Orion in action
A major European pharmaceutical manufacturer’s animal health vaccine facility in France shows what’s possible with cold WFI implementation at production scale. The company contracted Veolia to provide water purification systems for its new manufacturing site, where controlling bacterial growth and limiting chemical consumption were critical requirements for weekly thermal disinfection cycles.
The facility installed an Orion MKIII 9000 S system producing cold WFI through integrated softening, RO and EDI technologies with full hot water sanitization. The cold WFI design received approval from the manufacturer’s German headquarters and delivers cost and energy savings compared to traditional distillation, while maintaining the pharmaceutical-grade water quality required by vaccine production. Local service support from Veolia’s French team provides ongoing maintenance and technical assistance.
Beyond equipment: Veolia’s service and expertise
Veolia’s pharmaceutical efforts include experience with most of the top 20 global pharmaceutical companies across multiple regions and facility types. Our work spans Europe, where Veolia maintains its most established pharmaceutical presence, the United States, where the company continues expanding its footprint, and throughout Latin America and Asia Pacific, where pharmaceutical markets are growing at a 9.3% CAGR — the fastest rate globally.
System reliability over 10- to 20-year operational lifecycles depends on comprehensive service support. Veolia’s preventative and predictive maintenance packages provide the documented upkeep that regulatory inspections require. When inspectors audit facilities, they expect maintenance records that demonstrate consistent system care, backed up by documented evidence to provide system reassurance and compliance.
Veolia’s Life Science Centre of Excellence in Dublin addresses a common pharmaceutical industry challenge: Facilities often cannot tour competitor sites due to proprietary concerns, making it difficult to evaluate equipment before purchase. The Centre houses a complete, validated Orion system that runs continuously for customer demonstrations and serves as a training facility for Veolia’s service engineers. Customers can review full validation documentation, observe system operation under pharmaceutical conditions and arrange specialized training on water treatment fundamentals or GMP requirements.
The Centre also provides comprehensive service training for Veolia engineers, which enhances customer confidence in system reliability over its operational life.
Service capabilities extend beyond clean water. Veolia also addresses the complex wastewater that pharmaceutical facilities generate, from active pharmaceutical ingredient (API) production streams to PFAS-contaminated water. Evaporator systems can concentrate waste for more economical disposal while recovering additional water for reuse. This end-to-end approach, spanning clean water generation through waste treatment, differentiates Veolia in a market where competitors typically specialize in one area or the other.
Contact our experts to discuss how pharmaceutical water solutions can support your facility’s requirements.
Author | Ranj Rihal
Growth Manager, Pharmaceuticals and Cosmetics, Veolia Water Tech
