QbD1200+ Analyseur de COT de laboratoire

Simple. Reproductible. Intuitif.

L'analyseur de COT QbD1200+ est conçu pour rendre les contrôles simples, reproductibles et intuitifs. Offrant une validation et un rapport simplifiés sur les données cryptées, il est conçu pour répondre aux exigences du 21 CFR Part 11 et aux principales réglementations de la pharmacopée mondiale : USP, EP, JP, IP, KP.

L'analyseur de COT QbD1200+ est doté d'un capteur infrarouge numérique non dispersif (NDIR) avec correction automatique de la dérive pour garantir une stabilité à long terme. Il fournit des résultats fiables et reproductibles grâce au contrôle de la température du réacteur UV, à la détection dynamique du seuil et à la réduction de la contamination d'un échantillon à l'autre. Pour minimiser la maintenance et simplifier les workflows, 7 capteurs différents permettent de vérifier automatiquement le système à chaque fois que l'instrument est mis sous tension et de surveiller l'instrument en permanence.

Caractéristiques de l'analyseur de COT QbD1200+

Tranquillité d'esprit

  • Conforme aux normes USP, JP, EP, IP, KP, ICH
  • Routine de qualification IQ/OQ/PQ
  • Capteur numérique NDIR permettant une auto-correction des écarts
  • Réduction de la contamination d'un échantillon à l'autre
  • Gestion rationalisée et sécurisée des données
  • Rapports simplifiés, données cryptées, protocole sécurisé
  • Prise en charge des exigences 21 CFR Part 11

Simplifier les workflows

  • Étalonnage automatisé en 120 minutes
  • Contrôles automatisés du système pour minimiser la maintenance
  • Validation simplifiée
  • Gamme automatique et dilution automatique des échantillons concentrés
  • Débit de gaz porteur défini par l'utilisateur

Faible coût total de détention

  • Aucun PC n'est nécessaire
  • Un seul réactif pour toutes les analyses
  • Maintenance guidée pour un temps de fonctionnement maximal

Une analyse fiable et simple... et bien plus encore


Resources + Tools
21 CFR Part 11 Questions les plus fréquentes Demander une offre Documents techniques
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Content and Resources

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QbD1200 Evaluating Carryover Technical Note
ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems <span style="color: #4d4d4d;">Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters</span><span style="color: #4d4d4d;">. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document</span><span style="color: #4d4d4d;">2</span><span style="color: #4d4d4d;">&nbsp;from the International Conference on Harmonisation.</span>
Calibrating the QbD1200 TOC Analyzer The calibration of a TOC Analyzer is a crucial part of ensuring a quality measurement.
ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems This page discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document2 from the International Conference on Harmonisation.
Achieving Compliant Batch Release – Sterile Parenteral Quality Control This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.

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FAQ on the QbD1200+ Laboratory TOC Analyzer

How does the QbD1200+ Laboratory TOC Analyzer manage inorganic carbon?

A water sample can contain total inorganic carbon (TIC), from dissolved CO2 and carbonates, and total organic carbon (TOC), from organic compounds. Some analyzers calculate TOC by subtracting TIC from total carbon, which can introduce measurement error when TIC is much higher than TOC.

The QbD1200+ Laboratory TOC Analyzer removes TIC from the sample before measurement. It then uses UV light and persulfate to oxidize the remaining organic carbon into CO2. A CO2-free carrier gas moves the CO2 to the detector for measurement. This process measures TOC without calculating it from separate TIC and total carbon results.

How much sample water is required in each vial to be analyzed?

The amount of water sample required depends on the number of analysis replicates selected by the user.

For water samples with <4,000 ppb TOC, 8 mL of water sample is consumed when analyzing each sample from the vials loaded into the autosampler. In addition, the sample line forward-flush performed at the start of each new vial analyzed uses 5 mL of the water sample in the vial. So, for example, if the autosampler was configured to analyze three samples from each vial, then analyzing each vial would consume:

(3 x 8 mL) + 5 mL = 29 mL of water/vial

How is UV lamp usage monitored?

The QbD1200+ analyzer records the UV lamp’s hourly usage as the UV lamp is only turned on during the oxidation section of each water sample TOC analysis. The maintenance screen displays the usage information and provides instructions for replacing the UV lamp.

How do I prepare One Reagent for the QbD1200+ Laboratory TOC Analyzer?

Measure 10 mL of One Reagent stock solution into a 1 L volumetric flask. Add ultrapure water with less than 100 ppb TOC to the 1 L mark, then mix the solution and transfer it to the reagent bottle. It is recommended that you prepare the diluted solution fresh each day. Store the reagent at 5 °C and protect it from direct sunlight.

How long does the QbD1200+ Laboratory TOC Analyzer UV lamp last?

The UV lamp will typically last >12 months, supporting an annual service and calibration interval.

How does the QbD1200+ Laboratory TOC Analyzer control sample measurement and dilution?

The QbD1200+ Laboratory TOC Analyzer uses a syringe pump in its hydraulic system. Auto-ranging can adjust the measurement range automatically for higher-concentration samples. If a sample is diluted before analysis, the user can enter a dilution factor so the analyzer adjusts the reported result.

How does the QbD1200+ Laboratory TOC Analyzer avoid sample-to-sample carry-over?

The QbD1200+ analyzer flushes the reactor after each measurement. If significant carryover occurs, it is recommended that you examine the carrier gas supply and contact technical support if the problem continues.

How often does the QbD1200+ Laboratory TOC Analyzer require service and calibration?

The service interval for the QbD1200+ Laboratory TOC Analyzer is 12 months. The QbD1200+ Laboratory TOC Analyzer continuously monitors all critical parameters and stops the analysis and reports an on-screen alarm should any critical parameter fail, i.e. the QbD1200+ Laboratory TOC Analyzer continuously monitors: UV light intensity, reagent, carrier gas, NDIR performance, Peltier cooler and syringe pump.

How does the QbD1200+ Laboratory TOC Analyzer avoid interference from residual trace amounts of CO2 from the last measurement?

Before each measurement, the baseline starting point for the measurement in the NDIR detector is established so that any residual CO2 in the NDIR can be eliminated from the TOC measurement.

How does the QbD1200+ Laboratory TOC Analyzer support system suitability testing ?

The QbD1200+ Laboratory TOC Analyzer includes guided qualification procedures for SST500, SST8000, SDBS, calibration, background, and accuracy testing. The analyzer displays instructions for preparing the required reagent and standards. Users enter the standard lot identification number and expiration date before starting the applicable procedure.

How does the QbD1200+ Laboratory TOC Analyzer Auto-Range function work?

The QbD1200+ Laboratory TOC Analyzer has a measurement range of 0 to 5,000 ppb. This range is extended by accurate dilution of the sample to be tested by a factor of up to 20X, utilizing a high-accuracy syringe pump (+/-1% accuracy). Thus, the QbD1200+ Laboratory TOC Analyzer can analyze samples of up to 100,000 ppb.

In applications where the TOC level in the samples is expected to be >4,000 ppb, the auto-ranging function can be enabled by the user using the configuration settings. First, the QbD1200+ Laboratory TOC Analyzer draws 1 mL of One Reagent into the syringe, followed by 1 mL of the sample and then 8 mL more of One Reagent. The combined solution is then dispensed into UV reaction module; a quick estimation of the TOC level is made to determine whether there is a need for sample dilution. The level of dilution depends on the amount of TOC present in the sample. The auto-range function can be turned off through the QbD1200+ Laboratory TOC Analyzer menu.