OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENTdonatella
欧盟OMCL 网络
质量保证文件
PA/PH/OMCL (06) 86 DEF
QUALIFICATION OF EQUIPMENT
设备确认
ANNEX 2: QUALIFICATION OF GC EQUIPMENT
附件2：GC (气相色谱仪)设备的确认
ANNEX 2 OF THE OMCL NETWORK GUIDELINE
“Q UALIFICATION OF EQUIPMENT”
OMCL网络指南之附件2“设备的确认”
QUALIFICATION OF GC EQUIPMENT
GC (气相色谱仪) 设备的确认
Introduction
介绍
食品安全 英语作文The prent document is the cond Annex of the core document “Q ualification of Equipment”, and it should be ud in combination with it when planning, performing and documenting the GC equipment qualification process.
本文件是核心文件“设备的确认”的第二附件，在规划、执行和记录GC设备的确认过程时，其应该和核心文件一起使用。
台灯英文The core document contains the general introduction and the Level I and II of qualification, common to all type of instruments, and the prent 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 ud to carry out the checks.
核心文件包含简介和确认的I和II阶段，它们对所有类型的仪器都是通用的。而现在的附件包含的是与GC仪器相关的需要检测的建议参数和其相应的典型验收标准限度值，以及方法方面可以用来开展这些检测的实际例子。
The tests propod in the Level III and IV of qualification are bad on an overall approach, in which veral 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).
确认的III和IV阶段里建议的检测是建立在整体方法之上的，在这种方法里好几个参数是在综合检测程序里同时检测的，目的是获得系统性能的全面信息( 例如，峰面积精度，保留时间精度，温度方案的重现性，等)
Nevertheless, it should be noted that it is also acceptable to check the parameters individually by using other well-defined procedures.
不过，应该指出的是，用其他明确的良好的程序来单独检测这些程序也是可以接受的。
TABLE III 表III Level III. Periodic and motivated instrument checks
阶段III. 定期和专门的仪器检查
Examples of requirements for GC instruments
with FID
配备FID的GC仪器的要求举例
TABLE IV 表IV
subsampleLevel IV. In-u instrument checks
阶段IV. 在用仪器的检查
Examples of requirements for GC instruments with FID
配备FID的GC仪器要求举例
这需要与被分析物的目标浓度联系起来确定。
All parameters given here should be checked when performing analys under the working condition
s for the actual sample determinations. Normally, the test and reference solutions to be prepared for this purpo are given as a part of the method.
这里给出的所有参数应该在工作条件下对实际样品的测定结果进行分析时进行检查。正常情况下，为此目的配制的供试溶液和标准溶液是作为该方法的一部分。
PA/PH/OMCL (06) 86 DEF - OMCL Guideline on Qualification of GC equipment (Annex 2)
ANNEX I 附件I
Level III. Periodic and motivated instrument checks
阶段III. 对仪器的定期和专门检查
Practical examples of tests and their associated tolerance limits for veral parameters related to the performance of the different modules of a GC are prented below.阵亡将士纪念日
下面展示的是检测GC仪器不同模块性能的实际例子及其参数的误差限度。utp
The examples can be considered by the OMCLs as possible approaches to perform the Level III o
f the equipment qualification process: “Periodic and motivated instrument checks”. OMCLs 认为这些例子可以用来执行设备确认过程的阶段III“对仪器进行定期和专门检测”。Several tests are propod 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 ud, as for example, the “G rob Tes t”mixture, available from different suppliers (e.g. Alltech, Sigma, Thames Restek). This commercial solution should be appropriate to the column material ud.
建议同时做几个测试来检测不同的参数（全面检测）。为了以更经济的方法进行检测，其他合适的解决方法也可以使用，例如,“Grob Test”混合物，可以从不同的供应商( 例如, Alltech, Sigma, Thames Restek )处得到。这个商业化的解决方案应该适用于使用的色谱柱材料。
It is recommended to run the overall tests by using always the same test column, exclusively dedicated to qualification purpos, to guarantee reproducible conditions. 建议只使用专门用于确认的同一根色谱柱来进行全面检测，以确保条件的可重现性。
exercibook
1.INLET SYSTEM 进样系统
The following tests are propod for the periodic and motivated check of the GC Inlet System.建议对GC进样系统的定期和专门检测实施以下检测
circle of friends1.1.INJECTOR LEAK TEST 进样器密封性(检漏)检测
曲轴修理Method方法:
characterize
If not otherwi 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.
如果仪器厂家没有特别说明，密封性检测根据仪器说明书上写的程序进行，或者仪器内的自动泄漏检测程序进行。
Otherwi u the test described below: 否则就使用下面的检测方法
Disconnect the column from the injector and clo the injector outlet with a aled cap.
从进样器上断开色谱柱，用密封帽封住进样器出口
Clo the ptum purge and the bypass. 关闭隔膜和旁路
Adjust the flow and pressure controller to the maximal possible value of the pressure gauge.
