Sievers 860 Laboratory TOC Analyzer & GE Autosampler RT12

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1 Water & Process Technologies Fact Sheet Sievers 860 Laboratory TOC Analyzer & GE Autosampler RT12 High Performance at an Affordable Cost for General Pharmaceutical Water Testing Requirements, Inc.

2 The Sievers 860 Affordable, High Performance The Sievers 860 Laboratory Total Organic Carbon (TOC) Analyzer from was designed specifically for pharmaceutical applications. Based on the proven technology used in the bestselling Sievers 900 Laboratory model, the new Sievers 860 provides excellent analytical performance at an affordable price. It offers a streamlined feature set designed to meet general pharmaceutical water testing requirements. Like other Sievers TOC analyzers, the Sievers 860 is easy to set up, operate and maintain, and requires no special operator training. To keep cost of ownership low, the Sievers 860 needs no internal reagents. The innovative DataPlus software makes the Sievers 860 more than an analyzer. Featuring an intuitive PCbased interface, the software lets you easily manage the data sample points in your water system and comply with global TOC monitoring requirements, such as Applications the US, European, Chinese, Indian, and Japanese Pharmacopeias (USP, EP, ChP, IP, and JP). Manufactured by the General Electric Company (GE), Sievers TOC Analyzers bring a strong tradition of innovation, quality, and reliability. When regulatory compliance and public safety is critical, partnering with an established, trusted manufacturer is essential to control risks. Sievers is the leading pharmaceutical TOC analyzer brand, and more than 10,000 Sievers TOC Analyzers have been installed throughout the world. The Sievers 860 TOC Analyzer was designed for general pharmaceutical water testing, including Water for Injection (WFI) and Purified Water (PW). It has a linear range of 0.3 ppb to 1.5 ppm, and offers a more robust alternative to the direct conductivity method. Sievers 860 Highlights Proven Sievers Technology The Sievers 860 is based on the industry-leading Sievers 900 Laboratory TOC Analyzer. It uses the Sievers Membrane Conductometric TOC technology that provides unsurpassed analytical performance and reliability. Regulatory Compliance The Sievers 860 complies with the IP, USP, EP ChP, JP, and other major global pharmacopeia requirements. Affordability The Sievers 860 s streamlined feature set was carefully designed to reduce costs, but still offer high performance for select pharmaceutical applications. One-Touch Operation The Sievers 860 can operate with or without a PC. Using the Analyzer keypad, standard TOC measurements can typically be run with just a single push of a button. Best-in-Class Software The Sievers 860 has an intuitive PC-based interface for easy analyzer operation, data management, document creation, and pharmaceutical regulatory compliance. The DataPlus software gives operators new insight into water system performance. DataPlus lets you monitor each sampling point, chart trends, and quickly identify changes in water quality. Low Maintenance The Sievers 860 provides one-year calibration stability and needs only a few hours of annual preventive maintenance. Reliable Company and Brand Established in 1878, GE is known for continuous innovation and high quality. GE s Sievers brand brings industry-leading TOC analysis technology to the global pharmaceutical market. GE s skilled service engineers and distributor network in India are ready to address customer questions and service needs.

3 Sievers Membrane Conductometric TOC Technology The Sievers 860 uses the Sievers Membrane Conductometric Detection method, which has proven to be an extremely reliable technique for measuring TOC. It uses a gas-permeable membrane that selectively passes only the CO 2 produced from the oxidation of organics. By preventing compounds such as acids, bases, and halogenated compounds from interfering with the measurement of CO 2 from oxidation, the Membrane Conductometric Method delivers unmatched sensitivity, selectivity, stability, accuracy, and precision. This technique also can tolerate higher conductivity and remove inorganic carbon more effectively than TOC analyzers that use the direct conductometric technology. DataPlus Software The Sievers 860 can operate standalone or with a PC. When using a PC, the innovative, easy-to-use DataPlus* software allows users to operate the Sievers 860, manage and analyze water sample data, and comply with pharmaceutical water testing regulations. The most robust laboratory TOC data management tool available, DataPlus lets you: Set up sampling protocols in just minutes. Create trending charts for a single sample point for internal quality control and troubleshooting. Export data as.csv or.xls files, and print reports and trending charts in pdf format. Track consumables usage and conduct routine maintenance easily. Run up to four Sievers TOC analyzers from one PC via an Ethernet connection. Firmware Upgrades Firmware can be updated easily using a USB key. You can take advantage of the latest features and optimize performance without changing hardware. Options and Accessories DataGuard Software Sievers DataGuard software for the Sievers 860 offers comprehensive support for compliance with the FDA s requirements for control of electronic records and electronic signature. DataGuard provides an administratively controlled user access system, complete audit trail functionality, and electronic signature management for compliance with 21 CFR Part 11. DataPlus Sample Point Trending Graph DataPlus Measurement Screen

4 GE Autosampler RT12 The GE Autosampler is a highly-automated, compact accessory for optimizing laboratory TOC measurement and is designed for use with the Sievers 860. The GE Autosampler RT12 is designed to increase productivity and enhance ease of use. Offering the highest degree of reliability, the RT12 requires little maintenance or adjustment. Key features and benefits include: Single-line connection and operation via DataPlus With only one cable, the GE Autosampler RT12 can connect to both the Sievers 860 TOC analyzer and the power supply. Using a computer and the DataPlus software you can operate the Autosampler easily. High sampling capacity and simultaneous in-vial sparging The GE Autosampler RT12 can handle up to mL vials. Because of its rotary design, it is easy to set up the sampling sequence according to the vial position in the rack. The RT12 enables overnight calibration and verification to ensure the Sievers 860 is ready to go the next day. The GE Autosampler RT12 has the same sipper needle design as the Sievers 860,so it can conduct in-vial sparging before sampling. When IC is high especially when it is involatile IC acidification is needed. Sparging effectively reduces the inorganic carbon and enhances measurement accuracy. Compact, space-saving size The RT12 s slim 23.1-cm wide profile requires minimal bench space. When operated side-by-side with the 21.5-cm wide Sievers 860 Laboratory Analyzer, the two units occupy just 46.6 cm of horizontal space. The RT12 only requires three connections a sample inlet tube, a gas liquid waste outlet tube, and a power cable to the Sievers 860 keeping the lab bench neat and clean. Sievers Certified Standards and TOC Vials offers Sievers Certified Reference Materials, including calibration and verification standards, for the Sievers 860, as well as reliable and economical 40-mL TOC vials. GE Autosampler RT12 Specifications 1 Capacity Twelve (12) 40-mL vials Power Supply Power supplied by the Sievers 860 Laboratory TOC Analyzer Ambient Temperature 10 C to 40 C Normal Operating Environment Intended for indoor use only Maximum Relative Humidity Up to 95%, non-condensing Maximum Altitude 3,000 m (9,843 ft) Dimensions H: 36.8 cm (14.5 in); W: 23.1 cm (9.1 in); D: 25.4 cm (10.0 in) Weight 3.9 kg (8.6 lb) Safety Certifications CE

5 Sievers 860 Laboratory System Specifications 1 Total Organic Carbon Linear Range Precision Accuracy Analysis Time Sample Flow Rate (nominal) 0.3 ppb 1.5 ppm TOC 0.1 ppb or 1%, whichever is greater ± 5% at 500 ppb C of sucrose 6 minutes Analysis mode: 0.25 ml/min Fast Flush (between samples): 0.5 ml/min Sample ph <3 Sampling Method Grab sampling Operation PC or standalone operation; one PC can control up to four analyzers Analyzer Specifications Power Requirements ±10% VAC, 60 W, 50/60 Hz Fuses T1.6 A, 250 VAC (SloBlo), size 5 x 20 mm (appliance inlet) Ambient Temperature 10 C to 40 C Normal Operating Environment Intended for indoor use only Maximum Relative Humidity Up to 95%, non-condensing Maximum Altitude 3,000 m (9,843 ft) Sparge Gas (if used) Inlet pressure: 30 psig to 50 psig Sparge Gas Flow Rate 120 ml/min to 150 ml/min Calibration Stability Typically stable for 12 months Outputs One USB port to support printer or Flash drive, and one Ethernet port Installation/Overvoltage Category II Safety Certifications CE, ETL listed. Conforms to UL Std Certified to CSA C22.2 No Pollution Degree 2 Display Color LCD Dimensions H: 43.0 cm (16.9 in); W: 21.5 cm (8.5 in); D: 40.5 cm (15.9 in) Weight 10.5 kg (23.0 lb) * Trademark of General Electric Company; may be registered in one or more countries. 1 Stated analytical performance is achievable under controlled laboratory conditions that minimize operator and standards errors. The Americas 6060 Spine Road Boulder, CO USA T T F geai@ge.com Europe/Middle East/Africa Unit 3, Mercury Way Urmston, Manchester UK M41 7LY T +44 (0) F +44 (0) geai.europe@ge.com India C 402, Delphi Hiranandani Business Park Powai, Mumbai India T +(91) F +(91) geai.india@ge.com ISO 9001:2008 QUALITY MANAGEMENT SYSTEM 2011, General Electric Company. All rights reserved Rev B MC11-168