GE Analytical Instruments Knowledge Center
GE Analytical Instruments, a division of GE Water & Process Technologies, manufactures the world's most sensitive, selective and robust scientific instruments and is the leading provider of Total Organic Carbon Analyzers to the pharmaceutical industry. Pharmaceutical and biopharmaceutical companies worldwide rely upon the Sievers brand of TOC analyzers for monitoring pharmaceutical waters for USP, EP and JP compliance in lab and process environments, and for process analytical technology (PAT) and other quality initiatives such as on-line compendial water release and cleaning validation.
Sievers TOC Analyzers are based on patented membrane conductometric detection technology and are known for their superior analytical performance, high automation and ease of use. New models include the reagentless 500 RL On-Line TOC Analyzer and the application-specific 900 Series (Portable, Laboratory and On-Line).
Other pharmaceutical industry products include the new battery-powered CheckPoint Portable/On-Line TOC Sensor, the Cleaning Validation Support Package (CVSP), Sievers TOC Standards and Sievers Certified (<10 ppb)TOC Vials.
Quick Facts
GE Analytical Instruments
6060 Spine Road
Boulder, Co. 80301
USA
www.geinstruments.com
geai@ge.com
Phone: (303) 444-2009
Fax: (303) 444-9453
Table of Contents
Podcasts
Podcast: Real Time Release and the Potential Role of Online TOC
By GE Analytical Instruments
In the first of this two-part series, Jonathan Yourkin, pharmaceutical market manager with GE Analytics, discusses pharma's adoption of real-time release and PAT, and the potential role that online TOC could play in moving industry closer to the Desired State.
Podcast: Online TOC and Real-Time Release on the Global Stage
By GE Analytical Instruments
In the second of this two-part series, Jonathan Yourkin, pharmaceutical market manager with GE Analytical Instruments, provides insight on navigating the subtle, and sometimes dramatic, differences between pharmacopeia and regulators in the U.S. and abroad in regards to the use of online TOC. Yourkin also shares best practices for applying TOC to PAT applications and real-time product release.
Back to TopWhite Papers
Deciphering VVQ: How Validation, Verification and Qualification Affect Total Organic Carbon Analyzers
By GE Analytical Instruments
With cleaning validation the fundamental question is ,"How clean is clean?" With Total Organic Carbon (TOC) instruments and methods, the question is whether to perform validation, verification, or qualification. Part of the question is not necessarily which mode to use, but, "Does the method or instrument 'suit' its purpose?" Given the current confusion regarding the use of TOC for compendial and analytical method purposes, this paper demonstrates what mode (validation, verification, or qualification) of choice should be used for TOC instrumentation or the methodology.
Supercritical Water Oxidation (SCWO): A New Wet Oxidation Process for TOC Analysis
By GE Analytical Instruments
Sample matrices can create analytical obstacles and calibration challenges during routine Total Organic Carbon (TOC) analysis. This paper describes a novel approach to wet chemical oxidation employing both heat and pressure, and present data showing the Sievers InnovOx TOC Analyzer's calibration robustness and long-term stability.
CheckPoint: A Breakthrough Total Organic Carbon Sensor for Ultrapure Water (UPW) Applications
By GE Analytical Instruments
Accuracy is a key consideration in the proper selection of a TOC device. TOC Sensors exhibit significantly less accuracy than TOC Analyzers, but provide the benefit of lower cost, easier operation, faster analysis and a smaller footprint, therefore choosing a TOC Sensor versus a TOC Analyzer is a matter of intended use. This paper outlines this dilemma, and describes how GE's CheckPoint TOC Sensor optimizes the use of TOC Sensors in diagnostics applications.
A Science-based Performance Comparison of On-line TOC Analyzers
By GE Analytical Instruments
Most pharma companies in the U.S. and Europe use laboratory total organic carbon (TOC) analyzers for the U.S. and European Pharmacopeia compendial TOC release of water to manufacturing in order to improve quality and lower the costs of producing purified water. The basis of a properly designed and qualified on-line TOC-based real-time release (RTR) system is to identify and understand the critical parameters for success. The study described in this white paper by GE Analytical Instruments focuses on the performance capabilities of pharmaceutical on-line TOC analyzers.
Deciphering VVQ — How Validation, Verification and Qualification Affect TOC Analyzers
By GE Analytical Instruments
With cleaning validation the fundamental question is, “How clean is clean?” With Total Organic Carbon (TOC) instruments and methods, the question is whether to perform validation, verification, or qualification. This paper is intended to demonstrate what mode (validation, verification, or qualification) of choice should be used for TOC instrumentation or the methodology
The Right Analytical Method For The Right Application: TOC Analysis For Cleaning Validation
By GE Analytical Instruments
This paper investigates the advantages of using a non-specific method for cleaning validation over more traditional analytical methods such as HPLC. It also looks at TOC methods and shows how using Sievers TOC technology can result in greater resource productivity, improved yields, reduced equipment downtime, and a better bottom line.
Back to TopApplication Notes
Quality Control of TOC Measurements
By GE Analytical Instruments
This application note by GE Analytical Instruments offers insights into the use of its total organic carbon (TOC) analyzers including calibration, verification, system suitability and the use of laboratory control samples.
Taking Mystery out of Maximum Allowable Carryover (MAC) Calculations
By GE Analytical Instruments
This application note by GE Analytical Instruments presents a step-by-step understanding specific for establishing acceptance criteria limits for cleaning with the use of total organic carbon (TOC).
Validating the TOC Method for Cleaning Validation Applications in the Pharmaceutical Industry
By GE Analytical Instruments
This application note by GE Analytical Instruments provides examples of parameters as they relate to total organic carbon (TOC) method validation, including detection and quantitation limits and determination of accuracy and precision of the analyte.
Comparison of TOC Analyzers and Sensors for Pharmaceutical TOC Applications
By GE Analytical Instruments
In 2006, Jon S. Kauffman, PhD., Lancaster Laboratories, published results from a study on the recovery of organic compounds likely to be present in pharmaceutical water systems using on-line TOC analyzers designed for pharmaceutical use. A new study repeats the same injections, but adds the new CheckPoint TOC Sensor from GE Analytical Instruments.
PAT application: At-line TOC for Cleaning Validation and Product Changeover
By GE Analytical Instruments
The Food and Drug Administration's 2004 PAT guidance document for improving pharmaceutical manufacturing efficiency and quality discusses using at-line methods for data collection. This application note from GE Analytical Instruments demonstrates the applicability and capability of at-line total organic carbon (TOC) analysis for periodic swab sampling for cleaning validation and applying the same practices for product changeover using the Sievers 900 Portable TOC Analyzer.
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