The Sievers 500 RL was the first TOC analyzer designed for real-time release of pharmaceutical waters.

500 RL Applications

The 500 RL On-Line was designed to optimize the following pharmaceutical applications:

Real-time Release and Process Analytical Technology (PAT)

The Sievers 500 RL On-Line Total Organic Carbon (TOC) Analyzer provides continuous, on-line quality assurance for the real-time release of Process Water (PW) or Water for Injection (WFI), meeting a key role in the FDA's Process Analytical Technology (PAT) initiative. It is designed to deliver science-based risk management capability to the production floor. The 500 RL can help pharmaceutical and biopharmaceutical companies comply with the PAT initiative and significantly reduce equipment downtime, eliminate the delays and costs associated with laboratory analyses, and achieve more cost-effective and higher quality pharmaceuticals. The 500 RL also measures USP <645> conductivity, and helps ensure that product waters meet quality requirements during the entire production run.

Cleaning Validation

The FDA encourages on-line TOC analyzer use for cleaning validation processes such as controlling the end point of equipment rinse down, and to help eliminate manual errors in the manufacturing process.

On-line Monitoring

The Sievers 500 RL provides on-line TOC analysis developed specifically for the USP and EP requirements. Based upon patented technology developed for NASA, these instruments are not susceptible to artificially high results observed with older, on-line technology. The 500 RL features the patented, Integrated On-line Sampler (IOS™) or the Super IOS for introducing standards during instrument validation.