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Anwendungsdatenblätter
TOC Fusion
Release Date: March 2011 The rapid and precise measurement of organic carbon in trace levels of water is of interest to the pharmaceutical, drinking water and environmental industries where regulations restrict the amount of discharge or contamination. Total Organic Carbon (TOC) analysis is considered an effective indicator of organic contamination in water. Since the US EPA set limits on Disinfection By-Products (DBPs) in 1979 and subsequently required testing, TOC analysis has slowly taken the forefront of accurate and rapid testing for DBPs water contamination. Municipalities and other drinking water facilities follow various recognized national and international methodologies to ensure compliance with the US EPA regulations including US EPA 415.3, 9060A, and SM5310. This study will focus on using a UV/ Persulfate analyzer to meet US EPA drinking water regulations using SM5310.
Release Date: December 10, 2010 By taking an active approach to prevent cross-contamination in pharmaceutical and cosmetic production, international agencies such as the USFDA, ICH, EC, Health Canada, and the WHO have established regulations and guidelines for effective cleaning and sanitization. With the potential side effects due to exposure, limiting carry-over of residual compounds into subsequent batches is crucial. This study focuses on the analysis of cleaning validation samples using TOC without carryover concerns, negative impacts on precision or accuracy and the ease of developing a method for such analysis.
Release Date: March 9, 2010 In choosing a Total Organic Carbon (TOC) analyzer, among the many factors
that need to be given consideration are not only the current instruments
and their accessories available on the market, but specifically to their
method of sample oxidation in relation to the sample matrix. Different
oxidation techniques may affect the analytical data due to the components
within the sample matrix. This article highlights some analytical differences
and similarities between the two TOC analyzers utilizing Static Pressure
Concentration (SPC), patent pending, for the analysis of surface water
samples.
Release Date: March 9, 2010 In most instances, the task of routine instrument calibration and daily sample analyses for Total Organic Carbon (TOC) are uneventful. However, when there are samples that have elevated TOC levels outside of the calibrated range of the instrument, at least one of several processes are set into motion. These processes include but are not limited to halting the sample sequence, rinsing of the sample pathway to remove residue, dilution of the sample and reanalysis. These may be labor intensive and time consuming processes. This poster presents Intellidilution, which is a new and innovative way to automate the dilution and reanalysis of samples that are outside the calibrated range of a UV/ Persulfate TOC instrument.
Release Date: September 14, 2009 Total Organic Carbon (TOC) analysis is a fast and efficient analytical
technique that can be easily implemented in pharmaceutical manufacturing
for cleaning validation due to the all-inclusive nature of the test for
carbon. It can be used to test for residues of previously manufactured
products, cleaning detergents, solvents, by-products, and degradants.
Although the current requirement set by the pharmacopeias for instrument
performance is at 500 parts per billion (ppb), many pharmaceutical companies
regularly test at one-tenth and even one-hundredth that requirement. This
application note discusses guidelines for performing low-level TOC analysis
using a UV/ Persulfate analyzer.
Meeting the USEPA Method 415.3 Requirements Using a New UV/ Persulfate TOC Analyzer
Recovery of TOC in the Presence of High Levels of Dissolved Inorganic Carbon: TOC Methods for Ground/Drinking Water Analysis
Analysis of Total Organic Carbon Samples Containing NaCl Using Two Oxidation Techniques
Detection Selection for TOC Analysis: Analytical Considerations
for Cleaning Validation and Purified Water Testing The task of choosing a Total Organic Carbon (TOC) analyzer for cleaning
validation and purified water testing brings one to consider the many
techniques currently on the market. This becomes more difficult when faced
with understanding that TOC analyzer manufacturers may use different detection
techniques, which could affect the analytical data. This article highlights
some analytical differences between the two major TOC detection techniques
and offers suggestions for a process to base the choice upon the user’s
unique needs. A comparison of two commonly used techniques, Non-Dispersive
Infrared (NDIR) and
Simplifying the Process: Automated Japanese Pharmacopeia
Purified Water and Water For Injection Testing Using A Next Generation
TOC Analyzer The Japanese Pharmacopeia monographs provide guidelines and requirements for Total Organic Carbon (TOC) analysis of water for injection and purified water. These methods present a system suitability test that compares the recovery of a standard solution (rs) of sucrose, a relatively easy compound to oxidize, and the system suitability solution (rss) of Dodecylbenzenesulfonic Acid, the challenge compound. The response of reagent water (rw) is subtracted from each of these solutions’ responses to yield a corrected response. The maximum carbon concentration of the reagent water per these monographs is 100 ppb C. However, when reagent water concentrations are below 50 ppb C, greater accuracy may be obtained through lower instrument / reagent blank values. From the results, a response efficiency (E) is calculated by dividing the corrected system suitability solution response by the corrected standard solution response and multiplying by 100. According to both pharmacopoeias, the response efficiency must achieve between 85% - 115% for the instrument to be suitable for Total Organic Carbon (TOC) analysis on pharmaceutical pure water (PW) and water for injection (WFI) samples.
Simplifying the Process: Automated USP 643 / EP 2.2.44
Purified Water and Water For Injection Testing Using A Next Generation
Total Organic Carbon (TOC) Analyzer The United States Pharmacopoeia (USP) <643> and European Pharmacopoeia (EP) 2.2.44 monographs provide guidelines and requirements for Total Organic Carbon (TOC) analysis of water for injection and purified water. These methods present a system suitability test that compares the recovery of a standard solution (rs) of sucrose, a relatively easy compound to oxidize, and the system suitability solution (rss) of 1,4-benzoquinone, the challenge compound. The response of reagent water (rw) is subtracted from each of these solutions’ responses to yield a corrected response. The maximum carbon concentration of the reagent water per these monographs is 100 ppb C. However, when reagent water concentrations are below 50 ppb C, greater accuracy may be obtained through lower instrument / reagent blank values. From the results, a response efficiency (E) is calculated by dividing the corrected system suitability solution response by the corrected standard solution response and multiplying by 100. According to both pharmacopoeias, the response efficiency must achieve between 85% - 115% for the instrument to be suitable for total organic carbon (TOC) analysis on pharmaceutical pure water (PW) and water for injection (WFI) samples.
Introduction to the Fusion Total Organic Carbon (TOC)
Analyzer Building on nearly 40 years of design and manufacturing experience, Teledyne
Tekmar introduces its fifth
Using a Single Calibration Curve to Analyze a Wide Range
of TOC Samples Teledyne Tekmar has introduced its next generation UV/Persulfate Total Organic Carbon (TOC) analyzer – the Fusion Total Organic Carbon (TOC) Analyzer. The Fusion Total Organic Carbon (TOC) Analyzer uses Static Pressure Concentration (SPC) Nondispersive Infrared (NDIR) detection to achieve greater levels of accuracy and precision. Traditional analyzers use multiple calibration curves to analyze the spectrum of samples submitted for analysis. The Fusion Total Organic Carbon (TOC) Analyzer uses Teledyne Tekmar’s versatile TOC TekLink™ software, which uses a single calibration curve while still allowing a wide range of samples to be analyzed.
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Spezifikationen
Fusion
