Tuesday, December 14, 2010

Operation of Gas Chromatograph with Head Space


1.0   Purpose        :  The purpose of this SOP is to lay down the operation for Gas Chromatograph with   
                                        Head Space.
2.0   Objective      :  To  provide a guideline how the Gas Chromatograph with head Space used  in QC
                                 department in ---Pharmaceutical Ltd.
3.0   Scope           :  This SOP shall be applicable for operation of Gas Chromatograph with head   
                                 Space and train and qualify the person in Gas Chromatograph with head Space.
4.0      Responsibility:

·        Primary       :   QC Officer
·        Secondary   :   Overall: QC Manager

5.0      Procedure:

5.1             Instrument details:   

            Name              : Gas Chromatograph
            Make              : Shimadzu
Model No.      : GC-2010
I. D. No.          :
5.2       Operation:

5.2.1    Fix properly the Column, specified in specification of the material under testing.
5.2.2    Put “ON” the mains and switches of GC, computer and if necessary, Head space of Gas Chromatograph.
5.2.3    Double Click G C SOLUTION icon on desktop. G C SOLUTION software will get   open by computer.
5.2.4    After some   time,   dialog   box will appear on the screen. (Enter the User name Manager or real User name and password) and click ok.
5.2.5   After some time beep sound will give the indication that instrument & computer is connection between Instrument & soft ware.
5.2.6    After some time G.C. Real Time Analysis dialog will be seen on the screen.
5.2.7    Now fill the data for Detector, Colum , Injection port & Colum Oven in the
                                    Instrument menu.
5.2.8    Open the valve of Carrier gas (Nitrogen Cylinder / Helium Cylinder).  Check    the Gas leakage with the help of 50% IPA solution in water.
5.2.9    Open the valve of Air Cylinder and check the leakage of gas with the help of 50% IPA Solution in water.
5.2.10  Open the valve of Hydrogen Cylinder and check the leakage of gas with the help of 50% IPA Solution in water.
5.2.11 Close the air valve of GC and open the hydrogen valve to ignite the Flame.
5.2.12  Push the Set button on GC and open air valve on GC slowly. Flame will get    
            ignited automatically. Ignition of the flame will be indicated by increase in auto
             zero value.
5.2.13  Click on method & Select Instrument Parameters, check parameter like Column oven temperature, Detector temperature, Injection port temperature, and carrier flow.
5.2.14 Make any necessary correction required in instrument control parameter. After changing instrument control parameter, save the method files and exit.
5.2.15  Enter the name of file for storing data in Method file name field.
5.2.16  When system becomes ready, Inject the required quantity of sample as per individual monograph through the Injection port and immediately press START button on GC. Analysis will get started automatically and get stopped after given stop time.  Press ENTER key on computer to get data on the screen.
5.2.17  For use of auto sampler system, connect the transfer line to the capillary column parameters and activate the method on screen. Put the required vials of standards and sample in sample tray. When screen displays ready, click start button on the screen. The standard and sample vials will be taken automatically by the Headspace and same will get injected sequentially.

5.2.18 Results of Analysis get automatically stored in the file specified in set up command or in the sequence
5.2.19 Click the STOP Button from window after completion of analysis.
5.2.20 Select command File, select save data file for store the data.  Click   Print Report from    window & load the data from Data file    to get   print out of the reports.
5.2.21  Close the valve of Hydrogen Cylinder after completion of analysis.
5.2.22    After Hydrogen pressure decreases to Zero, disconnect the instrument from software.
5.2.23    Set the Column oven temperature to 25°C, Detector temperature to 0°C and Injector temperature to 0°C.
5.2.24  When all the temperatures  drop up to 25°C, close the valve  of  the Carrier  gas   and when pressure of carrier gas decreases   to Zero, put “OFF“ the G.C. and its mains.
 6.0   Precautions:

6.1       Do not heat the G.C. column without passing carrier gas through the column.

6.2       Check the leakage of Hydrogen gas before putting the flame on.

6.3       Check frequently the blue Silica gel of Gas filtration unit and  replace before it turns completely white.

6.4       Ensure that no air bubble is entrapped in syringe while injecting the sample.

6.5       If found any difficulty in operating the instrument or G.C. Solution software, and then refer the instrument manual.

6.6       Inform to the Department Head, If any abnormality is observed while working with Gas chromatograph

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