Water for injection (WFI) is a precise and highly regulated aspect of various pharmaceutical applications. Medical professionals use WFI to dilute drugs that require mixing with water before administering them via injection or infusion into the human body’s veins, muscles, or other tissues. Due to the medical nature of this solution, WFI must be completely sterile and avoid any contamination.
Such standards include validation requirements before the WFI is ready for administration. Conductivity measurements in WFI are essential for assessing purity, monitoring system performance, controlling the production process, validating purification methods, and preventing microbial growth. By utilizing conductivity measurements, WFI manufacturers can ensure the production of high-quality, compliant, and safe water for use in pharmaceutical and medical applications.
The Challenge: Ensuring WFI Standards are Met
WFI must meet strict quality standards before medical or otherwise sterile use. This includes verifying the performance of conductivity sensors and ensuring their calibration integrity. Coordinating sensor maintenance and validation activities, while also minimizing downtime, can be a complex task. Additionally, factors such as temperature and the condition of process equipment profoundly affect the quality of the WFI. Conductivity sensors used for WFI verification must also be capable of measuring values below 1.3 μS/cm. For WFI produced in the United States, the United States Pharmacopoeia (USP) is the governing body for verifications. Specifically, conductivity measurements conducted for WFI fall under guidelines set by USP <645>. Under these guidelines, conductivity levels must be as low as possible and may not exceed 1.3 μS/cm at 25°C.
The Solution to Ensuring WFI Standards are Met
The SE 605H conductivity sensor is specifically designed for the needs of hygienic applications like WFI. An integrated temperature element ensures accurate compensation of all conductivity measurements for the process media temperature. The sensor includes its own process connection with various hygienic options based on customer needs. The SE 605H also includes sensor verification methods that operators can perform on-site. CIP/SIP capabilities also make the SE 605H a suitable fit for applications that require sterilization such as WFI.
The Stratos Multi transmitter boasts intuitive user interface features full-text menu navigation, graphical icons, and charts to communicate the device’s condition and guided automatic sensor calibration. The Ethernet Industrial Protocol capability allows the transmission of diagnostics directly to the control system of the process. Data logging, sensor status recognition, and digital output capabilities can all boost the ease of use for operators and assist in staying on top of their process.
Customer ROI
Enhanced Operational Efficiency: Accurate measurements enable better control of the WFI process, leading to optimized use of resources and reduced operational costs. Ensuring that conductivity measurements meet the standards set by regulatory bodies like the FDA and USP can prevent costly fines and sanctions.
Minimized Downtime: Reliable conductivity sensors reduce the frequency of maintenance and calibration, leading to less downtime and higher productivity.
Consistent Product Quality: Accurate conductivity measurements help maintain the high purity of WFI, which is critical for the safety and efficacy of the final product. Hygienic measurement techniques reduce the risk of microbial contamination, which can lead to product recalls and excessive use of resources.
