Anatel PAT700 总有机碳分析仪

ANATEL PAT700 总有机碳（TOC）分析仪专为帮助验证符合 TOC 的药典要求以及纯化水和注射用水的电导率而设计。

TOC、无需电导率和温度补偿功能全集合于一台分析仪 - 可以完全校准和验证符合 USP<643> 和 USP<645> 标准
低购买成本 ——提供 12 个月服务和定期校准
支持根本原因分析 – 如果存在 TOC 异常，则自动采集水样
所有 SOPs 都预加载到 PAT700 中，提供屏幕图片和提示逐步引导用户使用仪器

文档及应用短文

*本产品仅供工业与科研使用，不用于临床诊断

功能特点

低购买成本

自动切换主和备用紫外线氧化灯，带紫外线输出监测功能，支持 12 个月维修间隔
无需化学品/试剂 – PAT700 仅使用强紫外线灯氧化 TOC
无需更换蠕动泵管或泵头 – PAT700 使用水系统压力将样品推入测量室进行分析

支持根本原因分析法

用户可以对 PAT700 进行预编程，可以预先设定 TOC 值，然后去捕获 1 个水样，之后在 QC 实验室中进行分析，以便协助进行根本原因分析，判断是否检测到 TOC 异常
板载抓取采样器允许用户从不同位置/使用点采集样本，以支持根本原因分析

提高合规性

PAT700 TOC 分析仪可完整校准和验证，以便符合 USP<643> 标准的 TOC 和 USP<645> 标准的电导率
完全氧化符合 EP 2.2.44 要求 – PAT700 通过氧化动态终点检测确保完全的 TOC 氧化
支持 21CFR 第 11 部分条款 – 日常用户可以以访客身份查看 TOC 和电导率结果，而无需对 PAT700 进行任何更改。通过多级用户名和密码保护保护初始配置和后续更改
双流版本可在水循环的开始和结束时同时证明合规性

减轻培训负担 – 无需手动计算/数据输入

所有 SOPs 都预加载到 PAT700 中，提供屏幕图片和提示逐步引导用户使用仪器
所有校准和系统适用性标准均附带经过认证的价值数据，并在瓶子本身的 RFID 标签中编程为日期。按照屏幕 SOPs 指示，系统会提醒用户加载瓶子，然后 PAT700 读取瓶子上的 RFID 标签。如果瓶子的装载顺序错误，或者这些瓶子已过期，则 PAT700 会在触摸屏上发出警告。然后，PAT700 上传认证值，执行测试并自动计算通过/失败结果并提供报告。

ANATEL PAT700 TOC 分析仪运行演示

产品规格明细

Industry Standards	EP <2.2.44>, USP <643>, 21 CFR Part 11
Fluid Compatibility	Purified water, Water for injection (WFI)
Online Operation	Sample inlet pressure 10 to 100psi (0.69 to 6.89Bar)

Detection	Differential conductivity
Reporting	ppb TOC │ µS/cm
产品货号	PAT700210

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Title	Description
ICH Q2	The International Conference on Harmonisation (ICH) is an expert working group with representation from the United States, European and Japanese Pharmacopoeias.
European Pharmacopoeia EP 2.2.44	Chapter 2.2.44 of the European Pharmacopoeia describes the procedures used to qualify a chosen method for analyzing total organic carbon (TOC)—and the interpretation of results in limit tests.
Validation of On-line Total Organic Carbon Analysers for Release Testing Using ICH Q2 {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	This paper discusses how characteristics for consideration during the validation of analytical procedures may be applied to on-line Total Organic Carbon (TOC) analysers to enable them to be used to provide release test data for Water for Injection (WFI) and Purified Water (PW).
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.
Maintaining Data Integrity: Understanding FDA ALCOA Guidance	21 CFR part 11 ALCOA defines good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate.
CIP（就地）清洗系统	保证生物反应器的环境清洁很重要，因此监管机构认为，在允许的条件下，生物反应器需要在生产后就地及时清洁（CIP）处理。
自动化生物制药质量控制以降低成本并提高数据完整性 {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	本文研究了四种常见的质量控制程序，以及自动化如何通过减少人为错误的机会来帮助提高数据完整性，同时还节省了时间并降低了运营成本。
Importance of TOC measurement in WFI in light of European Pharmacopoeia change {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper discusses the increased focus on Total Organic Carbon (TOC) and conductivity measurement, especially for companies seeking to use RO water treatment plants to create WFI, and provides best-practice advice for calibration.
21 CFR Part 11 Data Integrity for On-line WFI Instruments {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This application note takes a look at how quality-critical on-line Total Organic Carbon (TOC) and conductivity instrumentation for WFI (water for injection) quality control can be configured to help companies comply with the FDA’s expectations on data integrity, including the use of Microsoft Active Directory and PDF data export.
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.
Manufacturing Processes for Engineered T-Cell Therapy – CAR-T	Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
21 CFR Part 11 Data Integrity for On-line WFI Instruments	This whitepaper takes a look at how quality-critical on-line Total Organic Carbon (TOC) and conductivity instrumentation for WFI (water for injection) quality control can be configured to help companies comply with the FDA’s expectations on data integrity, including the use of Microsoft Active Directory and PDF data export.
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ANATEL PAT 700 总有机碳和电导率分析仪 {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	符合药典标准：美国药典、欧洲药典、日本药典
ANATEL PAT700 Total Organic Carbon (TOC) and Conductivity Analyzer Product Brochure {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	Product Brochure for the PAT700 TOC and Conductivity Analyzer
Validating On line TOC Analysers for Product Release using ICH Q2 {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	Whitepaper by Author Tony Harrison is a Compliance and Applications Specialist for Beckman Coulter Life Sciences \| Published 2017
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
ALCOA+ Infographic	Guidance on Maintaining Data Integrity Infographic
21 CFR Part 11 QC Instrument Suite {279C6CA2-9797-4CFE-9CAA-5EAFAC29B60D}	This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
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【カタログ】オンライン＆オフラインTOC計 ANATEL PAT 700 {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	"PAT 700型TOC計は、ユーザーフレンドリーで使い勝手の良い最新モデルです。オンライン測定に加え、品質管理などのラボ測定への切り替えにも対応可能です。

Anatel PAT700 总有机碳分析仪

请求报价

21 CFR Part 11

常见问题解答

技术文件

产品特点

请选择一款 ANATEL PAT700 分析仪型号

功能特点

ANATEL PAT700 TOC 分析仪运行演示

产品规格明细

相关文档

技术文件

Related Parts

ANATEL PAT700 Calibration Standards Kit

PAT700 Validation Standards Kit

PAT700 Suitability Standard Solution Kit

PAT700 Conductivity Standards Kit