仪器确认 附件2 GC确认 中英文.doc

OMCL Network of the Council of

Europe

QUALITY ASSURANCE DOCUMENT

质量保证文件

PA/PH/OMCL (06) 86 DEF

QUALIFICATION OF EQUIPMENT

仪器确认

ANNEX 2: QUALIFICATION OF GC EQUIPMENT

附件2：气相色谱仪的确认

ANNEX 2 OF THE OMCL NETWORK GUIDELINE

“QUALIFICATION OF EQUIPMENT”

OMCL网络指南“仪器确认”附件2

QUALIFICATION OF GC EQUIPMENT

气相色谱仪的确认

Introduction 介绍

The present document is the second Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the GC equipment qualification process.

本文件是核心文件“仪器确认”的第二个附件，在计划、实施和记录气相色谱仪的确认时，应将本文件与核心文件联合使用。

The core document contains the general introduction and the Level I and II of qualification, common to all type of instruments, and the present annex contains GC instrument-related recommendations on parameters to be checked and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry out these checks.

核心文件包括了一般介绍和第一级与第二级确认，适用于所有类型的仪器，本附件包括了气相色谱仪相关的建议，包括哪些参数需要检查，相应的典型可接受标准，以及用来进行这些检查的实践方法学例子。

The tests proposed in the Level III and IV of qualification are based on an overall approach, in which several parameters are checked at the same time in a combined test procedure, to obtain information on the overall system performance (e.g. peak area precision, retention time precision, temperature programme reproducibility, etc).

在第三级和第四级确认所建议的检查是基于一种全面检查的方法，在其中同一个联合测试可以检查几个不同参数，得到全面的系统性能信息（例如峰面积精密度、保留时间精密度、温度程序重复性等）

Nevertheless, it should be noted that it is also acceptable to check these parameters individually by using other well-defined procedures.

另外，需要注意如果采用其它界定很好的程序对这些参数进行单独确认也是可以接受的。

TABLE III表3 Level III. Periodic and motivated instrument checks

第三级周期主动仪器检查

Examples of requirements for GC instruments with FID

配备FID检测器的气相色谱仪的要求举例

TABLE IV 表四

Level IV. In-use instrument checks 第四级：在用仪器检查

Examples of requirements for GC instruments with FID 配置FID检测器的气相色谱仪为例

* This is to be defined in conjunction with the target concentration of the analyte

这要与分析物的目的浓度联系起来确定。

All parameters given here should be checked when performing analyses under the working conditions for the actual sample determinations. Normally, the test and reference solutions to be prepared for this purpose are given as a part of the method.

这里给出的所有参数应在工作状态下进行实际样品检查分析时进行检查。一般来说，供试液和对照溶液应根据此目的作为方法的一部分进行准备。

ANNEX I 附件1

Level III. Periodic and motivated instrument checks

第三级仪器周期主动检查

Practical examples of tests and their associated tolerance limits for several parameters related to the performance of the different modules of a GC are presented below.

下面是与不同GC模块的性能相关的几个参数检查的实践例子和其相关的允许限度

These examples can be considered by the OMCLs as possible approaches to perform the Level III of the equipment qualification process: “Periodic and motivated instrument checks”.

这些例子可以认为是OMCL可以使用的进行第三级仪器确认“周期主动的仪器检查”的方法

Several tests are proposed to check various parameters at the same time (overall tests). In order to run the tests in a more economical way, other suitable solutions can be used, as for example, the “Grob Test” mixture, available from different suppliers (e.g. Alltech, Sigma, Thames Restek). This commercial solution should be appropriate to the column material used.

建议同时检查几个参数（全面检查）。为了采用更经济的检查式，也可以使用其它合适的溶液，例如“Grob Test”混合物，可以从几个供应商处采购（例如Alltech, Sigma, Thames Restek）。这个商业化溶液应适用于色谱柱材料。

1. INLET SYSTEM 进样系统

The following tests are proposed for the periodic and motivated check of the GC Inlet System.

建议对GC进样系统周期主动检查实施以下内容

1.1. INJECTOR LEAK TEST 进器器泄漏检查

Method:方法

If not otherwise specified by the instrument manufacturer, the leak test is carried out according to the procedure laid down in the instrument manual or by the built in automatic leak check procedure of the instrument.

如果仪器供应商未另行指明，泄漏检查应根据操作手册指定的程序来进行，或者由仪器的内置泄漏自动检测程序进行。

Otherwise use the test described below:

否则采用以下所述检查

Disconnect the column from the injector and close the injector outlet with a sealed cap.