White Papers

The National Drug Code (NDC) is a unique identifier assigned by the U.S. Food and Drug Administration (FDA) to drugs intended for human use, facilitating tracking, reimbursement, and regulatory compliance. This white paper explains the purpose of the NDC, when it must appear on product labels, and why it is not required for Aquabiliti's bulk packaged water-based products, such as Water for Injection (WFI). Aquabiliti's products are designed exclusively for further manufacturing use – serving as components in biopharmaceutical production rather than finished dosage forms for direct parenteral administration. The absence of an NDC does not compromise the product's quality, safety, or suitability for its intended purpose, as these products adhere to stringent U.S. Pharmacopeia (USP) specifications, Current Good Manufacturing Practices (cGMP), and other regulatory standards. By clarifying these distinctions, this document aims to inform customers about appropriate NDC usage and reaffirm Aquabiliti's commitment to delivering high-purity, compliant solutions for the biopharmaceutical industry.

Water for Injection (WFI) is a critical component in pharmaceutical, biopharmaceutical, and medical device industries, requiring stringent control of impurities such as Total Organic Carbon (TOC) to ensure product safety and efficacy. This white paper explores the phenomenon of TOC increase in bulk packaged WFI over time, primarily due to the leaching of organic compounds from packaging materials. It highlights how this effect varies with packaging size, influenced by the surface area-to-volume ratio, with smaller containers exhibiting greater relative TOC contributions from leaching.

Two commonly used types of sterile water in the pharmaceutical, biopharmaceutical, and medical device industries are Sterile Water for Injection (WFI) and Sterile Water for Irrigation and they both serve distinct purposes, with different regulatory requirements and packaging allowances. This white paper outlines the differences between these two types of water, their permitted container sizes, and how Aquabiliti’s WFI, tested to USP Sterile WFI specifications and packaged in bulk, provides a practical and compliant solution for further manufacturing, laboratory, or research use.

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.

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.