GC-2010气相色谱仪标准操作规程(英文)

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GMP Document

Title:



Standard Procedure

Drafted by: _ Day _Month _Year

Document No.: SOP-CH-02-003-000 Effective Date: _ Day _Month _Year Page No.: 1/3

Operation

for GC-2010 Plus Gas Reviewed by: _ Day _Month _Year Chromatograph

Approved by: _ Day _Month _Year

Issued by: department Backup No.: 02 Reason for change

Quality

Distributed by: Equipment Department, Quality Department



1. Purpose: To ensure the smooth operation of GC-2010 plus gas chromatograph by establishing a standard operating procedure.

2. Scope: This SOP applies to the operation of GC-2010 plus gas chromatograph.

3. Responsibility: QC laboratory technician shall be responsible for this SOP and the director of laboratory assumes responsibility of supervision over and check of the effective implementation of this SOP. 4. Content: 4.1 Starting up

4.1.1 Select appropriate gas chromatographic column according to the standard requirements of the sample to be measured, and replace the chromatographic column.

4.1.2 Observe whether the silica gel inside the all-in-one machine of nitrogen, hydrogen and air changes color or not and whether the liquid level is normal or not. Open the all-in-one machine of nitrogen, hydrogen and air in case of no abnormality.

4.1.3 Open the switching valves of N2, H2 and Air on the all-in-one machine of nitrogen, hydrogen and air. Observe the pressure of N2 in the all-in-one machine of nitrogen, hydrogen and air. Start the GC-2010 Plus gas chromatograph when the pressure reaches more than 60MPa. 4.1.4 Enter the observing interface by clicking the button Moint on the host.


Document Name: Standard Operation Procedure for GC-2010 Plus Gas Chromatograph Document No.: SOP-CH-02-003-00

Page: 2 / 3

4.1.5 Open the computer workstation. Long sound beeping represents that the computer is online successfully.

4.1.6 Open the saved original method file or reset new parameters, including chromatographic column, injection port mode (split flow), column temperature, detector and end time (temperature: column temperature injection port detector). Auto-ignition is off. Method of creating new file: Click Save method file as to save the method under the method file, then click Download; Click Download directly in case of the saved original method file. 4.1.7 Click Start GC.

4.1.8 Observe the instrument state on the right of the workstation or the host display screen. Wait for the flow rate of carrier gas and the temperature of all components reaching the set values. 4.1.9 Select Ignition on the right of the workstation as status of ON to ignite. Beep sound appears. And the host of GC-2010 Plus gas chromatograph displays real flame image. 4.1.10 Prepare to inject the sample after the baseline is stable and the instrument gets ready. 4.2 Sample Analysis

4.2.1 Click Single analysis. Set name, ID and save path of the sample in the dialog box of Sample registration. Check Auto increment. Then click Ok.

4.2.2 When the dialog box of Start to collect data appears, inject the sample with micro-injector from the injection port and press the button Start on the host to conduct data collection. 4.2.3 The instrument will stop automatically and save the data file according to the end time set in the detector. If you want to stop the data collection in advance, you can press the button Stop after the peak appears and becomes stable.

4.2.4 The next single analysis can be performed when the instrument is in the state of “Be ready”. Make analysis and data collection on the standard sample and the sample to be tested in this way successively. 4.3 Data Processing

4.3.1 Open “GC Solution” on the desktop. Click Re-analysis in Processing tool and enter the data processing interface.

4.3.2 Find out the file to be processed in the destination folder. Click Manual integration in case there are impure peaks. Select appropriate processing method in the manual integration bar and get corresponding data including retention time, peak area, height and concentration.






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