Aquabiliti’s Water for Injection: Unparalleled Purity for Critical Applications
Author
Erik Smeltz, Process Engineer, Aquabiliti
July 18th, 2025
Abstract
In the pharmaceutical, biopharmaceutical, and medical device industries, the quality of water used in manufacturing processes is paramount. Water for Injection (WFI) is a critical component in ensuring product safety, efficacy, and compliance with stringent regulatory standards. Aquabiliti is proud to offer WFI that not only meets and exceeds the United States Pharmacopeia (USP) WFI specifications but also conforms to the rigorous criteria of ASTM Type 1A water directly off the WFI generation system, prior to packaging, establishing it as the purest WFI available for critical applications.
This white paper explores the unique attributes of Aquabiliti’s WFI, its compliance with industry standards, and its role in supporting the high purity requirements of pharmaceutical, biopharmaceutical, and medical device manufacturing.
The Importance of Ultra-Pure Water in Critical Industries
Water is a fundamental ingredient in the production of pharmaceuticals, biopharmaceuticals, and medical devices. It is used in drug formulation, equipment cleaning, sterilization processes, and as a solvent in bioprocessing. Contaminants, even at trace levels, can compromise product quality, patient safety, and regulatory compliance. The USP and other global standards, such as the European Pharmacopoeia (EP), set strict requirements for WFI to ensure its suitability for these applications.
ASTM Type 1A water, as defined by the ASTM D1193-06 standard, represents the highest standard for water purity, with stringent limits on conductivity, total organic carbon (TOC), endotoxin, and microbial contamination. While Aquabiliti does not specifically market ASTM Type 1A water due to the bulk nature of their products, Aquabiliti’s WFI generation system is designed to meet these criteria, ensuring unparalleled purity for all bulk WFI and manufactured water-based products. Table 1 directly compares the quality of Aquabiliti’s AQUAPure WFI to the USP standard, as well as for equivalent tests of the ASTM Type 1A standard.
Challenges in Producing ASTM Type 1A Quality Water
Not every company with a WFI generation system can produce water meeting the ASTM Type 1A criteria due to the following challenges:
System Design: WFI systems are optimized for sterility and endotoxin control, not the ultra-low conductivity and TOC levels required for Type 1A. Retrofitting existing WFI systems to meet Type 1A specifications is often impractical due to the need for advanced polishing steps.
Monitoring Requirements: Type 1A water demands real-time, high-precision monitoring to ensure consistent quality, which may exceed the capabilities of standard WFI systems.
Scale and Flexibility: Achieving Type 1A purity at large scales requires specialized equipment and processes, which many WFI systems are not designed to handle.
Aquabiliti’s Superior Approach to Water Production
Aquabiliti’s state-of-the-art WFI generation system, commissioned in 2023, is specifically designed to produce water which exceeds USP WFI specifications while meeting the purity criteria of ASTM Type 1A water. The following features set Aquabiliti apart:
Advanced System Design: Aquabiliti’s multi-stage purification system includes reverse osmosis, electrodeionization, ultraviolet oxidation, and final polishing steps required to achieve Type 1A specifications. Real-time monitoring ensures consistent quality, even at large-scale production levels.
Point-of-Use and Single-Use Technology: Aquabiliti employs a point-of-use system that transitions to single-use components, eliminating cross-contamination risks and reducing cleaning validation requirements.
Municipal Water Collaboration: A strong partnership with the local municipal water treatment facility allows Aquabiliti to receive advance notice of treatment changes, enabling proactive adjustments to maintain water quality.
Rigorous Maintenance Regimen: Aquabiliti replaces membranes and filters regularly, rather than always cleaning and reusing them, ensuring optimal system performance and preventing contamination buildup.
Proactive Quality Oversight: Routine monitoring and quality controls allow Aquabiliti to respond swiftly to any breached alert/action limits. Non-compliant water is automatically diverted to drain, ensuring only Type 1A-compliant water is used.
These features enable Aquabiliti to consistently deliver water that meets or exceeds both ASTM Type 1A and USP WFI standards, providing unmatched reliability for critical applications.
Why Choose the Highest Purity Water?
In industries where water is a critical component, the initial quality of water directly impacts downstream processes. Impurities in water, even at low levels, can accumulate through manufacturing steps, leading to:
Product Quality Issues: Trace contaminants can alter drug efficacy, cause product defects, or skew analytical results.
Process Variability: Inconsistent water quality introduces variability, complicating process validation and quality control.
Costly Failures: Contaminated water can lead to product recalls, equipment damage, or failed experiments, resulting in significant financial and reputational losses.
Aquabiliti’s WFI is designed to meet the purity of ASTM Type 1A water directly off the generation system, prior to packaging. This ensures that the water entering the packaging process is of the highest possible quality. By starting with Type 1A purity water, the risk of contaminant accumulation during downstream handling and further manufacturing is reduced, ensuring greater reproducible outcomes and minimizing delays in product release. Aquabiliti’s ability to deliver this level of purity, combined with its scalability and reliability, makes it the ideal partner for industries demanding the highest standards.
Conclusion
Aquabiliti’s Water for Injection sets a new standard in the pharmaceutical, biopharmaceutical, and medical device industries where purity directly impacts product quality and patient safety. By not only meeting and exceeding USP WFI specifications but also conforming to the rigorous criteria of ASTM Type 1A water directly off the WFI generation system, Aquabiliti ensures unparalleled water quality for the most demanding applications. For industries where quality cannot be compromised, Aquabiliti’s WFI is the clear choice.
For more information on how Aquabiliti’s WFI can support your manufacturing needs, please Contact Us today through our website or email our team at customercare@aquabiliti.com.
