iOS* ), provides reagentlesson-line TOC analysis for compliance with USP Chapter <643> and EP Chapter 2.2.44 TOC measurement requirements. It also provides USP Chapter <645> conductivity measurement.

Overview

The drive to improve quality andoperating efficiencies demands analytical tools that deliver process knowledge and automation. Reliable, real-time data on the pro- duction floor has become essential to most quality initiatives.As a result, many pharmaceuticalcompanies today are working to reduce risks and costs by transitioning Total Organic Carbon (TOC) measurement requirements for pharmaceutical water from laboratory to on-line instruments. There is also a trend to substitute more efficient on-line Toc analyzers for labor-intensive HPLC analysis in cleaning validation applications.GE Analytical Instruments designed the Sievers*500 RL On-Line TOC Analyzer to deliver science- based risk management capability to the produc- tion floor. This was largely achieved by integrating the trusted Sievers laboratory TOC methodology into a reagentless on line analyzer that delivers the same high level of analytical process capability associated with laboratory industrial analyzers—but without the delay.The 500 RL Analyzer features automated systemprotocols, such as validation and system suitability testing, as well as automated recording of pro- duction information for Sievers Standards. Data encryption facilitates secure distribution of ana- lytical data for review.The 500 RL, equipped with a Sievers integrated On-Line Sampling System (

Pharmaceutical Applications

On-Line Cleaning Validation

One of the pharmaceutical manufacturing indus- try’s most costly, resource-constraining activities is cleaning validation (CV). As the industry focuses on automating more processes critical to improving manufacturing efficiencies, the benefits of real- time, on-line cleaning validation are clear.The 500 RL monitors TOC and conductivity of therinse water to determine equipment status during cleaning. To facilitate implementation of on-line CV, GE Analytical Instruments also provides com- prehensive documentation via the CV Support Package (CVSP). The 500 RL and CVSP together deliver trusted technology and the applications expertise needed to confidently transition to on- line cleaning validation.

Real-Time Release of Pharmaceutical Waters

The 500 RL On-Line TOC Analyzer provides continu- ous, on-line quality assurance for pharmaceutical water release, significantly reducing equipment downtime and eliminating the delays and costs associated with laboratory analyses. The 500 RLalso measures USP <645> conductivity, and helps ensure that product waters meet quality require- ments during the entire production run.