TOC QbD1200

O novo analisador TOC QbD1200 foi projetado para tornar os testes mais fáceis, reprodutíveis e precisos. O novo analisador TOC promete o mais alto desempenho, reduzindo drasticamente o custo de propriedade usando um reagente para o teste e exigindo apenas uma visita de serviço anual em vez de manutenção frequente. O novo analisador TOC elimina a dependência de longas rotinas durante a noite que podem falhar. Inovador, o analisador QbD1200 TOC calibra em apenas 90 minutos. O QbD1200 foi projetado para ser usado em ambientes de laboratório em conformidade com a 21 CFR parte 11 e é totalmente compatível com todos os regulamentos globais de farmacopeia. Oferece validação conveniente, pois não é operado por um PC separado, eliminando a necessidade de um arquivo CSV adicional e fornece relatórios sem papel para distribuir todos os relatórios auditáveis por protocolo seguro para um servidor central.
QbD1200 TOC Analyzer

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21 CFR Part 11
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Características

Dados confiáveis

  • Pare de descartar a sua primeira amostra! O QbD1200 praticamente eliminou a transferência de amostra para amostra! Resultados altamente reproduzíveis!

Simplifique sua validação e análise

  • Calibrações automatizadas, testes de adequação do sistema e geração de relatórios! Apenas um reagente é necessário para TODA a análise!

Baixo custo de propriedade

  • Diga adeus à manutenção frequente; reduza as chamadas de serviço!

Conformidade regulamentar assegurada

  • Cumpre totalmente com todas as regulamentações globais da farmacopeia: USP, JP, EP, IP, ICH.

Calibração rápida

  • Calibração automatizada em menos de 90 minutos economiza o tempo precioso do usuário e é o mais rápido na indústria!

Introduction to the QbD1200 TOC Analyzer

Specifications for the QbD1200 TOC Analyzer

Performance 0.4 ppb detection limit (<2% or 3 ppb, whichever is greater)
Industry Standards 21 CFR Part 11, USP <643> (including Sterile Water SST), JP-16 <2.59>, EP <2.2.44>, IP, CP, KP, US EPA 5310c, ICH guidelines for instrument validation included in IQ/OQ
Light Source Broadband silicate photodiode sensor UV lamp confirmation
Sample Volume 64
Detection Digital NDIR Detector (limit: 0.4ppb)
Reporting Reporting Units: μg/L (ppb)
Item Specifications Referenced 9450100

Documentation

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Title Description
ALCOA+ Infographic
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Guidance on Maintaining Data Integrity Infographic
QbD1200 User Manual
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Manual for the QbD1200 TOC Analyzer (v4 - 11/2015)
Quality Control Testing Instrumentation Solutions for GMP Manufacturing Brochure
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Brochure on instruments designed for Raw Materials QC, Production QC, and Final Product QC
Brochure for QbD1200 TOC Analyzer
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The QbD1200 delivers the highest performance with unparalleled ease of operation and maintenance
21 CFR Part 11 QC Instrument Suite
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This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
Background Subtraction
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When measuring a water sample to quantify TOC (Total Organic Carbon), most TOC analyzers add some combination of reagents and dilution water to the initial sample in order to complete the measurement
Overload Recovery
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In a typical laboratory environment, a TOC analyzer is used to measure water samples where the TOC value of those samples is unknown
JP SDBS Validation
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JP 16 specifies that when measuring a 500ppb standard of sodium dodecylbenzenesuflonate (SDBS), a TOC analyzer should recover a value of at least 450ppb (90% recovery)
Method Overview
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A water sample initially contains two types of carbon: Total Inorganic Carbon (TIC) (from CO2 gas dissolved in H2O and dissolved carbonates in the water) and Total Organic Carbon (TOC) (from organic species)
Calibration
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The calibration of a Total Organic Carbon (TOC) Analyzer is a crucial part of ensuring a quality measurement
Importance of TOC measurement in WFI in light of European Pharmacopoeia EP 2.2.44 change
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Whitepaper by Author Tony Harrison is a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017
Detection Limit
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When considering which instrument is appropriate for a given application, it is common to consider various performance characteristics
ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems
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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 document2 from the International Conference on Harmonisation.
USP System Suitability
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The US Pharmacopeia (USP 36-NF 31, section <643>) provides specific guidance on how to qualify TOC instrumentation for use
Root cause investigation for pharmaceutical water systems
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In this whitepaper we discuss some typical sources of contamination in water systems and how root-cause investigations can be supported using on-line Total Organic Carbon (TOC) analysers.
Preparing Reagent Solution
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The QbD1200 uses a mixture of phosphoric acid (to aid in removal of CO2 from solution) and ammonium persulfate (to aid in oxidizing organic compounds)
Inorganic Carbon Removal
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A water sample initially contains two types of carbon: Total Inorganic Carbon (TIC) (from CO2 gas dissolved in H2O and dissolved carbonates in the water) and Total Organic Carbon (TOC) (from organic species)
21 CFR Part 11 Compliance Matrix - QbD1200
Teste de liberação de água para fabricação conforme as BPF
QbD1200 TOC Analyzer Features
Overload Recovery
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Processos de limpeza no local (Clean in Place, CIP)
Detection Limit
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Achieving Compliant Batch Release – Sterile Parenteral Quality Control
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Inorganic Carbon Removal
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European Pharmacopoeia EP 2.2.44 and Total Organic Carbon
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ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems
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Background Subtraction
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Method Overview
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USP System Suitability
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JP SDBS Validation
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QbD1200 Preparing Reagent Solution
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Calibrating the QbD1200 TOC Analyzer
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