QbD 1200

Анализатор TOC QbD 1200 разработан для быстрого, точного и надежного определения общего органического углерода. Высокая производительность прибора сочетается с низкими эксплуатационными издержками за счет использования всего одного аналитического реагента. Кроме того, прибор не требует постоянного технического обслуживания – достаточно осуществлять сервисное обслуживание один раз в год. Встроенная система самодиагностики не позволит прибору продолжать анализ, если кончился газ-носитель или реагент. Калибровка TOC QbD 1200 занимает всего 90 минут. Прибор соответствует нормативам 21 CFR часть 11 и международным фармакопейным требованиям. Для управления прибором не требуется внешний компьютер, что исключает необходимость валидации компьютерного оборудования и хранения дополнительных CSV-файлов. Электронные отчеты об измерениях передаются на хранение в центральный сервер по безопасному каналу связи.

Особенности

Надежные результаты

Забудьте об исключении первого результата анализа! Мы практически устранили перенос материала от образа к образцу и добились высокой воспроизводимости результатов!

Упрощенные валидация и анализ

Автоматические калибровка, тест на пригодность системы и формирование отчетов! Для анализов всех типов нужен всего один реагент!

Низкие эксплуатационные издержки

Забудьте о постоянной технической поддержке. Достаточно звонка в сервисный центр всего один раз в год!

Быстра калибровка

Автоматическая калибровка за 90 минут сэкономит драгоценное время. Быстрее не бывает!

Соответствие требованиям

Полностью соответствует международным фармакопейным требованиям: USP, JP, EP, IP, ICH.

Introduction to the QbD1200 TOC Analyzer

Таблица спецификаций

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

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Название	Описание
21 CFR Part 11 Compliance Matrix - QbD1200
QbD1200 Preparing Reagent Solution {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	The QbD1200 TOC Analyzer uses a mixture of phosphoric acid (to aid in removal of CO2 from solution) and ammonium persulfate (to aid in oxidizing organic compounds).
Background Subtraction {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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.
USP System Suitability {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	QbD1200 is designed so that System Suitability is very convenient and easy to perform.
Method Overview {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	The QbD1200 is unique in that it combines all required reagents (acid, oxidizer, and dilution water) into a single reagent instead of requiring multiple reagents.
JP SDBS Validation {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	The QbD1200 has a built in qualification routine, “SDBS”, which makes performing a JP 16 compliant validation convenient.
Detection Limit {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	For Detection Limit (DL), often referred to as Limit of Detection (LOD), both ICH and JP 16 offer clear direction.
Inorganic Carbon Removal {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	To quantify TOC, all analyzers must incorporate a strategy to account for the TIC. However, not all of these strategies are equally effective or reliable.
Overload Recovery {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	Experienced operators can develop reasonable expectations about what the TOC values will be and the measurement values will tend to fall within an expected range most of the time.
Calibrating the QbD1200 TOC Analyzer {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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 {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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.
European Pharmacopoeia EP 2.2.44 and Total Organic Carbon {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper discusses the background behind the European Pharmacopoeia’s focus on complete oxidation of TOC in the light of the increased importance of on-line Total Organic Carbon (TOC) and conductivity measurement.
Clean in Place CIP Processes	CIP systems are becoming standard for pharmaceutical manufacturing facilities regulated by good manufacturing practices (GMP)
Water Release Testing for GMP Manufacturing	The quality of the water used in manufacturing is defined by the global Pharmacopoeias who have harmonized the parameters and requirements for Purified Water (PW) and Water for Injection (WFI).
QbD1200 TOC Analyzer Features
USP System Suitability {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	The US Pharmacopeia (USP 36-NF 31, section <643>) provides specific guidance on how to qualify TOC instrumentation for use
Method Overview {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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)
ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems	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.
ALCOA+ Infographic	Guidance on Maintaining Data Integrity Infographic
Detection Limit {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	When considering which instrument is appropriate for a given application, it is common to consider various performance characteristics
JP SDBS Validation {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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)
Preparing Reagent Solution {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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)
Overload Recovery {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	In a typical laboratory environment, a TOC analyzer is used to measure water samples where the TOC value of those samples is unknown
Importance of TOC measurement in WFI in light of European Pharmacopoeia EP 2.2.44 change {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	Whitepaper by Author Tony Harrison is a Compliance and Applications Specialist for Beckman Coulter Life Sciences \| Published 2017
Quality Control Testing Instrumentation Solutions for GMP Manufacturing Brochure {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	Brochure on instruments designed for Raw Materials QC, Production QC, and Final Product QC
Root cause investigation for pharmaceutical water systems	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.
Background Subtraction {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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
Inorganic Carbon Removal {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	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 {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	The calibration of a Total Organic Carbon (TOC) Analyzer is a crucial part of ensuring a quality measurement
QbD1200 User Manual {611E05FD-FC41-4E23-9498-DA5662F8D4F9}	Manual for the QbD1200 TOC Analyzer (v4 - 11/2015)
21 CFR Part 11 QC Instrument Suite {279C6CA2-9797-4CFE-9CAA-5EAFAC29B60D}	This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
Product Solutions for Viral Research Workflows {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	Brochure: Discover product solutions for sample collection, isolation and preparation, virus identification, antibody analysis, and vaccine and therapy development.
Brochure for QbD1200 TOC Analyzer {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	The QbD1200 delivers the highest performance with unparalleled ease of operation and maintenance

QbD 1200

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