Pharmaceutical regulatory monitoring

Sievers TOC analyzers meet all USP, EP, and JP regulations for TOC monitoring.

Regulatory Monitoring

The United States Pharmacopoeia (USP), European Pharmacopoeia (EP), Japan Pharmacopoeia (JP), Chinese Pharmacopeia (ChP) and Indian Pharmaceopeia (IP) regulations require TOC to be monitored in pharmaceutical waters. GE Analytical Instruments provides both laboratory TOC analysis, as well as on-line TOC monitoring solutions for process waters (PW) and water for injection (WFI), to meet growing regulatory requirements.

Whether you choose to monitor on-line, off-line, or both, GE Analytical Instruments has the solution for you. With our Sievers membrane conductometric detection technology, GE Analytical Instruments analyzers demonstrate higher sensitivity than non-dispersive infrared (NDIR) instrumentation and no halogenated organic carbon interference compared to conductometric TOC instrumentation. Because Sievers TOC Analyzers require no carrier gases or external reagents, operation and maintenance costs are very low.

On-line Monitoring

The Sievers 900 Series and 500 RL TOC Analyzers provide 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 900 On-Line, 900 Portable, and the 500 RL feature the patented, Integrated On-line Sampler (IOS™) or the Super IOS for introducing standards during instrument validation.

The independent study by Dr. Kauffman of Lancaster Laboratories, Comparison Study of On-line TOC Analyzers, confirms the validity of earlier on-line TOC comparison studies performed by GE Analytical Instruments (A Science Based Performance Comparison of On-Line TOC Analyzers). The paper also discusses critical information in the most recent Japanese Pharmacopeia (JP15) suggesting that the user must be very careful when using direct conductometric on-line TOC technology with either USP <643> or EP 2.2.44 TOC.  Dr. Shigeo Kojima (Senior Advisor, Japan Pharmaceutical & Medical Devices Agency) provides an expanded explanation of the problems with using direct conductivity on-line TOC analyzers as described in the Japanese Pharmacopeia 15 TOC section (Dr. Kojima on TOC in JP15).

On-line or Off-line Monitoring

The versatile 900 Series includes three models (900 Laboratory, 900 Portable, and 900 On-Line) offering one or more of the following capabilities for pharmaceutical water monitoring: on-line, grab sample, or autosampler for high-volume laboratory analysis.