Water for Injection (WFI) is a water quality standard defined by pharmacopeial groups worldwide. WFI is used for the most critical pharmaceutical products and applications including mandatory use for injectable drugs, hemofiltration, irrigation, in the production of some active pharmaceutical ingredients, implantable medical devices and other varied applications.
Water for Injection has been historically produced by distillation, as this was the only acceptable treatment process in the past. As advances in reverse osmosis, electrodeionization, and ultrafiltration occurred over the years, and manufacturers gained experience using membrane technology to produce highly purified water, regulators re-evaluated which technologies were required for the production of WFI. The outcome was the 2017 harmonization of WFI regulations among the major Pharmacopeias, allowing the use of membrane-based alternatives for WFI production.
Membrane based WFI systems produce water that allows for consistent, reliable compliance with WFI monograph requirements for current United States Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and most other worldwide pharmacopoeias.
WFI is the purest grade of pharmaceutical bulk water. The critical quality attributes include conductivity, total organic carbon (TOC), bacteria and bacterial endotoxin, as shown in the table below.
| USP | Ph Eur. | JP | |
|---|---|---|---|
| Conductivity | <1.3 uS/cm at 25° C | <1.3 uS/cm at 25° C | <1.3 uS/cm at 25° C |
| Total Organic Carbon | <500 ppb | <0.5 mg/L | <0.5 mg/L |
| Bacteria | <10 CFU/100ml | <10 CFU/100ml | <10 CFU/100ml |
| Endotoxin | <0.25 IU/ml | <0.25 IU/ml | <0.25 IU/ml |
Note: conductivity values reported are one value from a table of equivalent acceptable conductivity/temperature points.
Membrane based WFI systems can provide capital cost reduction up to 70% and operating cost reduction up to 90% relative to distillation. Energy savings with membrane technology will be different for multiple effect and vapor compression distillation but offer significant reduction potential versus both alternatives.
| Typical Comparison of Energy Costs (Distillation vs. Membrane) per 1,000 gallons steam and power | |
| 4 Cell Multiple Effect Distillation | $57.56 |
| 6 Cell Multiple Effect Distillation | $43.26 |
| Vapor Compression Distillation | $24.84 - $28.00 |
| Membrane WFI | $0.50 - $4.60 |
Note: Assumptions: steam: $20.60/1000#; power: $0.07/kw-hr
Selecting the right equipment and operating procedures to produce the appropriate water quality is critical, along with maintaining quality with appropriate storage and distribution procedures.
Evoqua’s VRx system is specifically designed to meet the challenging needs of the pharmaceutical industry and provides a cost-effective method for producing WFI. Utilizing a combination of softeners, carbon filtration, UV light, particle filtration, reverse osmosis, electrodeionization and ultra filtration technologies, the VRx system provides reliable, high quality WFI.
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Evoqua’s fully engineered SDRx storage and distribution system maximizes water quality by maintaining five process controls including flow rate, pressure, temperature, microbial management and regular system sanitization. This system is designed to complement the VRx process water generation system and can be sanitized using hot water or ozone for maximum microbial management.
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Proper sanitization is critical to maintain water quality and Evoqua offers options for both hot water and ozone sanitization. Pacific Ozone, an Evoqua brand, is a leader in ozone technology and provides a full range of systems that are available as stand-alone packages or as part of a fully integrated water system.
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