Buying Water vs. Building a Water Infrastructure for Drug Manufacturing
Author
Timir Patel, RPh
May 19, 2025
Abstract
As biopharmaceutical manufacturing evolves, there is debate as to whether a company needs an in-house water system. This white paper examines the strategic and operational considerations of buying high-purity Water for Injection (WFI) versus building traditional water infrastructure. With the rise of single-use technologies, purchasing pre-treated WFI offers reduced capital costs, increased flexibility, and simplified compliance, making it a compelling option for new builds and retrofits alike.
Background: The Critical Role of Water in Drug Manufacturing
Water is an essential component in biopharmaceutical and vaccine manufacturing, playing a vital role in production, formulation, and equipment cleaning. These industries rely on differing grades of water purity, with WFI being the highest standard for injectable, ophthalmic, and inhaled drugs, as well as for cell culture and bioreactor cleaning.
Biologic drug production is especially water-intensive, consuming over 100 times more water than small-molecule manufacturing. A single 20,000-L monoclonal antibody (mAb) facility can use 1.5 million gallons of water annually, with downstream purification, especially chromatography, accounting for the largest share. 1 Considerable amounts of water are also required to clean and sterilize stainless steel manufacturing equipment. The clean-in-place (CIP) process requires large volumes of cleaning agents and multiple water rinses. This is then followed by more water for steam sterilization (SIP). While single-use strategies eliminate the need for CIP/SIP, water requirements to support the manufacturing process remain high.
Biological manufacturing processes using fermenters or bioreactors have significantly higher water requirements than manufacturers of small-molecule active pharmaceutical ingredients (APIs) and 503B compounding pharmacies. Access to a steady supply of WFI is still critical for the production of small-molecule drugs and the compounding process.
Proposed Solution: Evaluating the Case for Buying Water
Even drug manufacturing facilities utilizing single-use technologies often maintain legacy water systems, raising questions about cost efficiency and operational flexibility. The decision to generate water on-site or purchase pre-treated water is becoming an increasingly relevant discussion as manufacturers seek to optimize sustainability and efficiency in drug production and compounding.
Traditional water generation systems consist of water purification generators, extensive piping, storage tanks, and cleaning infrastructure. The upfront capital investment can reach hundreds of millions of dollars for large-scale facilities. These systems require continuous maintenance and, more critically, can be a source of operational inefficiencies. Contamination risks in piped water systems can lead to costly corrective actions, regulatory filings, and production downtime.
Case Study: Amgen Singapore
Amgen’s facility in Singapore is an example of where adopting a single-use strategy resulted in notable efficiency. By adopting a single-use production model, the company reduced water consumption by 58%. 2 This transition highlighted the cost savings in both capital expenditure (CapEx) and operational expenditure (OpEx) associated with single-use technology and reducing reliance on traditional water systems.
Single-Use Technologies and Water Use Reduction
The adoption of single-use systems has drastically changed how water is consumed in manufacturing. Traditional stainless steel systems require extensive cleaning, contributing to substantial water consumption. Single-use technologies, including disposable mixers, liners, and filtration systems, eliminate much of this cleaning requirement, reducing water consumption and mitigating contamination risks.
However, even with reduced water usage, many single-use facilities still maintain costly water systems, often out of necessity rather than efficiency. In existing facilities where water infrastructure is already built, the transition to single-use does not immediately eliminate the need for water treatment, but it does present opportunities to rethink how water is sourced and utilized.
Buying Water: A Practical Alternative?
For companies building new facilities or retrofitting existing ones, purchasing WFI presents a compelling alternative. Rather than investing millions of dollars in a water system, facilities can receive water in pre-sterilized, pre-packaged formats tailored to their needs. This approach offers multiple advantages:
Reduced Capital Expenditure: Eliminates the need for expensive water purification and piping infrastructure.
Operational Flexibility: Water can be transported within the facility using pre-sterilized bags and carts, reducing the need for extensive piping networks.
Regulatory and Quality Assurance Benefits: Pre-treated water comes with quality assurance documentation, reducing regulatory compliance burdens.
Environmental Considerations: Managing wastewater and adjusting pH before disposal is a concern for facilities with in-house systems. Purchased water limits on-site waste treatment requirements and simplifies compliance with environmental regulations.
Decision Factors: Evaluating Water Needs in Facility Planning
For companies evaluating whether to build a water system or buy water, the decision should be guided by several key considerations:
Production Scale: Large-scale biopharmaceutical plants with continuous production may still justify a built-in water infrastructure, while smaller or more flexible operations may benefit from purchasing water.
Single-Use Integration: Facilities that heavily incorporate single-use technologies will inherently have lower cleaning-related water demands.
Existing Infrastructure: Companies with legacy water systems must weigh the cost of maintaining and upgrading infrastructure against the benefits of a more modular approach.
Regulatory and Environmental Compliance: Wastewater disposal and treatment considerations may influence the decision to maintain an in-house water system.
Total Cost of Ownership: Beyond CapEx, companies should assess ongoing maintenance, contamination risks, personnel costs, and regulatory filings associated with in-house water systems.
The Future of Water for Injection in Drug Manufacturing
The industry’s shift toward flexible, modular, and single-use solutions suggests that the reliance on traditional water systems may continue to decrease. As drug manufacturers evaluate their options, the ability to buy high-purity water as needed offers an attractive alternative that aligns with modern manufacturing efficiencies.
For companies planning new facilities, the question is no longer just about how to build a water system; it’s also about whether building one is necessary at all. With single-use advancements and alternative water sourcing options, the future of water use may look very different from the past.
About the Author
Timir Patel, RPh, is the managing director and chairman of the board of Aquabiliti. He is also a co-founder of the company and has served in various positions there since 2005, including as CEO from 2010 to 2022. He is a graduate of the University of Maryland School of Pharmacy. Email him at tpatel@aquabiliti.com.
References
1 Bunnak, P., Allmendinger, R., Ramasamy, S. V., Lettieri, P. and Titchener-Hooker, N. J. Life-cycle and cost of goods assessment of fed-batch and perfusion-based manufacturing processes for mAbs. Biotechnol Prog. 32, 2016: 1324-1335.
2 https://www.amgen.com.sg/about/-/media/Themes/CorporateAffairs/amgen-com-sg/amgen-com-sg/PDF/amgen-singapore-fact-sheet.pdf
