GC设备的确认(中英) Qualification of GC equipment
- 格式：rtf
- 大小：4.36 MB
- 文档页数：13
OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT欧盟OMCL 网络质量保证文件PA/PH/OMCL (06) 86 DEFQUALIFICATION 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 EQUIPMENTGC (气相色谱仪) 设备的确认Introduction介绍The present document is the second Annex of the core document “Q ualification 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“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。
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 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).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 these 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 instrumentswith FID配备FID的GC仪器的要求举例TABLE IV 表IVLevel IV. In-use 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 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。
ANNEX I 附件ILevel 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 several parameters related to the performance of the different modules of a GC are presented below.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。
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”. 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 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 “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 used.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 purposes, 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。
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进样系统的定期和专门检测实施以下检测1.1.INJECTOR LEAK TEST 进样器密封性(检漏)检测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。
Otherwise use the test described below: 否则就使用下面的检测方法Disconnect the column from the injector and close the injector outlet with a sealed cap.从进样器上断开色谱柱，用密封帽封住进样器出口Close the septum 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.调整流动和压力控制器到压力计的最大可能值Adjust the flow controller to zero.调整流速控制器到零。
Read the pressure after 1 minute and record the value. 1分钟后读压力值并记录Record the pressure after 5 minutes. 5分钟后记录压力值Limits限度:Pressure drop ≤ 15 kPa within 5 minutes. 5分钟内压力下降≤ 15 kPa1.2.INLET PRESSURE/FLOW ACCURACY AND STABILITY 进气压力/流速的准确性和稳定性A direct measurement of these parameters was not deemed practical or necessary, but the optimal conditions of flow/pressure can be verified by the overall test 1.直接测量这些参数是不实际或者不必要的，但是流动/压力的最佳条件可以通过全面检测1来确认。
