GE Analytical Instruments, a division of GE Water & Process Technologies, is offering a new Sievers 500 RL on-line TOC analyser.
The Sievers 500 RL 500 RL provides continuous quality assurance for on-line pharmaceutical water release and cleaning validation, supporting the industry focus on automating processes critical to improving manufacturing efficiencies.
Using proven Sievers laboratory TOC measurement technology, the reagentless, automated analyser incorporates features such as the Super iOS that automate high-risk and frequently performed activities, significantly reducing labour costs and eliminating the delays associated with laboratory analyses.
The new Sievers Super iOS standards introduction device fully automates the delivery of multiple standards. Featuring four vial ports that accept pre-built vial set cartridges, the Super iOS automates all system protocols including system suitability, verification, and calibration.
The Super iOS cartridges contain an embedded memory chip that stores and securely captures each standards" type, concentration, lot number, and expiration. That metadata is attached to the analytical results of the protocol. Data security is further enhanced by the availability of encrypted data output from the 500 RL. The Sievers DataShare 500 software allows users to open the 500 RL's encrypted data files for secure viewing and customised data report generation.
"Before designing the Sievers 500 RL, we investigated why so few companies were using TOC for real-time water release," said Stephen Poirier, vice-president of business development for GE Analytical Instruments. "We learned that reliability was their main concern. Our customers told us they needed a much higher level of reliability and automation to achieve their real-time release quality initiatives. By incorporating the widely validated Sievers laboratory TOC technology with new automation features in the 500 RL, we have essentially brought laboratory confidence to the production floor."
The new analyser has many productivity and ease-of-use features, including 12-month calibration stability, a colour touch-screen display, USB port, and minimal maintenance (a few hours per year). With a wide operating range of 0.03 ppb to 2,500 ppb, the 500 RL also measures USP <645> conductivity.
The optional Sievers DataGuard 500 software facilitates 21 CFR Part 11 compliance, including system security assurance, electronic signature capability, and the creation of an automatic, independently generated audit trail.