- Pharmaceutical-Grade Purity and Compliance
Produced in an ISO 13485-certified, GMP-compliant facility. Meets USP standards for Water for Injection (WFI). - Optimized for Critical Processes
Designed for formulation, cleaning, and manufacturing in pharmaceutical and biopharmaceutical environments. - Flexible Volume Options
Available in standard and custom packaging up to 1000 L, - supporting both small-scale and large-scale operations. - Reliable and Consistent Quality
Ensures dependable performance across all applications.
Our WFI Quality Water is 0.2μm sterile filtered at the fill time, ensuring the highest purity for pharmaceutical, biopharmaceutical, and diagnostic applications. Each batch undergoes rigorous quality control testing to maintain consistency and compliance with industry standards. Every WFI Quality Water includes testing per USP and a Certificate of Analysis (CoA) for full transparency and traceability.
ILC Dover’s WFI Quality Water is produced and filled in a state-of-the-art facility in Lillington, NC, featuring:
- ISO 9001:2015 Certified Quality Management System
- ISO 13485:2016 Medical Device Quality Management System
- Compliance with 21 CFR 820 cGMP Standards & FDA Registration
- ISO 7 Cleanrooms for Controlled Production Environments
- On-Site Analytical & Microbiology Testing for Quality Assurance
ILC Dover’s WFI Quality Water is designed for pharmaceutical and biopharmaceutical applications, ensuring unmatched purity, consistency, and compliance. Ideal for cleaning surfaces and equipment, preparing cell culture media and buffers, manufacturing high-purity aqueous reagents, and facilitating buffer exchange, our WFI Quality Water meets the highest standards.
Purification & Dispensing Process
Our WFI Quality Water undergoes a rigorous multi-step purification process to ensure the highest purity and compliance:
- Purification: Produced through steam distillation following reverse osmosis and deionization, then filtered through a 0.2-micron filter at the point of use — with no added substances.
Filling: Filled under validated conditions from a water system that meets current USP specifications.
Quality Monitoring: Routinely tested for conductivity, Total Organic Carbon (TOC), endotoxins, and heavy metals to ensure consistency and compliance.
Post-Production Details
Shelf Life: 2 years from the date of manufacture, as validated by the ILC Dover Stability Testing Program.
- Packaging Options: Available in standard and custom packaging up to 1,000 L or filled directly into specified containers.
Parameter | Limits | Units |
|---|---|---|
Batch Release Testing | ||
TOC | ≤500 | Ppb |
Conductivity | ≤1.3 | μS/cm |
pH | 5.0–7.0 | _ |
Bioburden | ≤10 | CFU/100 mL |
Endotoxin | <0.25 | EU/mL |
