Revolutionizing Single-Use Systems Integration for Water for Injection and Aqueous Solution Delivery and Filling
Author
Erik Smeltz, Process Engineer, Aquabiliti
June 27, 2025
Abstract
This white paper introduces Aquabiliti’s innovative approach to single-use systems (SUSs) for the delivery and filling of Water for Injection (WFI) and aqueous solutions for the ever-evolving needs of the biopharmaceutical, pharmaceutical, and medical device industries. By controlling the entire supply chain within a dedicated single-use facility, Aquabiliti ensures superior product quality, operational efficiency, and cost-effectiveness. Leveraging state-of-the-art cleanrooms, rigorous quality control, and over 30 years of expertise, Aquabiliti delivers customized, high-purity SUS solutions. This paper outlines the company’s infrastructure, vertical integration strategy, and deep technical capabilities that position us as a trusted leader in single-use technology.
Introduction
The biopharmaceutical, pharmaceutical, and medical device manufacturing industries demand flexibility, quality, efficiency, and competitive pricing from their vendors. Aquabiliti addresses these demands through our innovative approach to SUSs used for delivery and filling of our WFI and aqueous solutions. By controlling the entire supply chain, from concept to delivery, Aquabiliti can provide superior products that enhance operational efficiency, ensure product integrity through closed-system processing, and reduce costs for customers.
Background: Single-Use Innovation at Our Core
Aquabiliti operates an exclusively single-use facility, utilizing single-use mixers and equipment to eliminate cross-contamination risks and reduce cleaning validation requirements. This infrastructure enhances scalability, ensures compliance with stringent regulatory standards, and streamlines operations, allowing us to market products at industry-best prices. This makes Aquabiliti the ideal supplier for fulfilling customer orders to the highest quality standards.
Vertically Integrated Supply Chain
Aquabiliti’s manufacturing capabilities encompass the complete supply chain, from raw material sourcing to final product delivery. This vertically integrated approach provides complete control over the production of single-use systems and downstream WFI and aqueous solutions, delivering significant advantages to customers:
Enhanced Quality Control: In-house manufacturing in state-of-the-art ISO Class 7 cleanrooms allows for stringent monitoring of particulate and endotoxin levels, ensuring high-purity products.
Cost-Efficiency: Eliminating third-party dependencies reduces production costs, allowing Aquabiliti to offer competitive pricing.
Quality Assurance: Direct oversight ensures consistent quality and compliance with industry standards.
Supply Chain Reliability: In-house production mitigates external supply chain pressures, ensuring timely delivery to customers.
Regulatory Compliance: All products are guaranteed animal-origin-free and latex-free, aligning with global regulatory standards.
Industry Expertise and Innovation
Additionally, Aquabiliti’s founders pioneered single-use systems for the biopharmaceutical industry at their previous company and bring over 30 years of experience to the design and integration of SUSs. This expertise enables Aquabiliti to:
Provide expert consultation to optimize SUS integration into customer workflows.
Develop tailored SUS solutions that enhance process efficiency with managing the transfer and delivery of Aquabiliti’s WFI and aqueous solutions.
Stay at the forefront of single-use technology innovation, delivering cutting-edge solutions to meet evolving industry needs.
Conclusion
Aquabiliti is redefining single-use bioprocessing through our fully integrated single-use facility and end-to-end control of the supply chain. By combining in-house manufacturing, rigorous quality control, and unmatched customization capabilities, Aquabiliti delivers cost-effective, high-quality solutions that meet the unique needs of our customers. With decades of expertise and a commitment to innovation, Aquabiliti is poised to lead the bioprocessing industry into the future.
For more information about Aquabiliti and our approach, visit our Company Overview and Integrated Quality pages or contact us today.
