TOC Analyser Automates Electronic Documentation and Protocols
Jul 26 2007
The reagentless Sievers 500 RL On-Line TOC Analyser with Super iOS (Integrated On-Line Sampler) automates all system protocols and also accepts single standards and grab samples. The Super iOS utilizes vial set cartridges, pre-loaded with Sievers Standards and configured to automate system suitability, accuracy/precision/verification, linearity, or calibration protocols. The Super iOS automatically sequences through the vials unattended and resumes analysis upon successful completion of the protocol.
The Super iOS and Sievers vial set cartridges together enable secure data management. Each vial set cartridge includes an embedded memory chip that transfers standards type, concentration, lot number, and expiration to the Analyzer. This standards information is stored with the protocol results, creating a detailed protocol record and eliminating the need to manually document standards information.
The data can be accessed via DataShare 500, a PC-based program that facilitates secure export, and allows multiple parties to share and view the encrypted 500 RL TOC data. It cannot be manipulated or modified, ensuring data security consistent with 21 CFR Part 11 requirements.
Using the proven Sievers laboratory TOC measurement technology, the Sievers 500 RL delivers science-based risk management capability to the production floor for Process Analytical Technology (PAT) initiatives, real-time pharmaceutical water release and on-line cleaning validation.
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