Automation

The 500 RL is available with a Super iOS that fullyautomates all validation protocols, including sys- tem suitability. Protocol standards come in an innovative vial cartridge which is easily inserted into the Super

USP Chapter <645> ConductivityMeasurement and Compliance

The 500 RL Analyzer meets all USP Chapter <645>Stage One regulatory monitoring requirements, reporting raw conductivity, temperature, and tem- perature compensated conductivity. Start on the displaymenu initiates a protocol, with no further user action required. The 500 RL can also be pro- grammed to restart Toc analysis upon successful completion of most protocols.

Comprehensive Validation Support

Each 500 RL comes with professional and compre- hensive IQ (Installation Qualification) and OQ (Operation Qualification) documents. Optional PQ (Performance Qualification) documentation is also available for a complete validation solution. For cleaning validation applications, an optional CV Support Package provides protocols and docu- mentation to guide users through the process of validating TOC instrumentation for on-line CV.

Security

The 500 RL Analyzer protects data and the Analyzer from unauthorized user access. The 500 RL outputs encrypted data files for analysis and system protocol results to a USB Flash memory drive or serial port. The encrypted files can be opened only in the Sievers DataShare* 500 program and can not be modified. For situations where security is not a concern, non-encrypted data files also may be exported in a .csv format.The optional Sievers DataGuard* software facili-tates compliance with 21 CFR Part 11 electronic records regulations. DataGuard provides an administratively controlled user-access system supporting multiple users with unique passwords and complete audit trail functionality.

Simplicity

The advanced capability of the 500 RL is compli- mented by user-friendly features that make it easy and fast to install, operate, and maintain. The large, color touch-screen menu provides access to all Analyzer functions. In addition to displaying TOC data, trend graphs, and Analyzer status, the color interface provides real-time status of consum- ables and prompts the user when semi-annual maintenance is due.

Easy, Stable Calibration

With 12-month calibration stability and easy screen prompts to perform single-point or multi-point cali- bration protocols, the 500 RL makes on-site calibra- tion simple and convenient. Super iOS models allow for vial set cartridge insertion, with no further oper- ator action needed.
Main Analyzer Display Screen