SOP for Operation of Particle Size Analyzer.

1.0     Objective:                         

            The purpose of this SOP is to provide written procedure for operation of Particle Size Analyzer.

2.0        Scope:

            This SOP covers operation of Particle Size Analyzer makes CILAS 

3.0        Responsibility:  

            Jr. Research Officer/ Research Officer: Responsible for operation, calibration and maintenance of the instrument as per procedure.

Head of Department: Responsible for calibration and maintenance timely as per schedule.

QA Officer/ QA Manager: Review the record and governing the document.

4.0        Procedure:

4.1       Ensure that the instrument is visibly clean and free from dust.

4.2              Operating Procedure:

4.2.1    Switch ‘ON’ the air compressor. The   pressure must be 65 to 75 psi.

4.2.2    Switch ‘ON’  the computer system, monitor and instrument.

4.2.3        Double click on the Particle Size Analyzer icon or click on start menu and select Particle Size Analyzer.

4.3        For Dry Mode:

4.3.1   Click on the vaccum pump and open the red and yellow valve to clean up the sample flow line.

4.3.2        Press the ‘STOP’ symbol to stop the pressure airflow.

4.3.3   Click on the measurement icon and fill the reference number of sample, product name, client name, batch no. and name of operator.

4.3.4   Always keep the distribution value three in measuring mode.

4.3.5   Click on the ‘Background Measurement’ and measure the background and wait till highlight the sample measurement icon. (First laser is stabilized than acquisition count will be started)

4.3.6     Put the sufficient sample in sample compartment.

4.3.7 Click on the sample measurement icon. (First laser is stabilized than vaccum will be started with vibration in sample compartment). And wait for result.

4.3.8   After sample measurement is completed, the vaccum pump and both the valve are open to clean up sample flow line. After completion of cleaning pump and valve will be stopped at specified time.

4.3.9     To print the results of the measurement of sample, click on the results icon and press the space bar key to select the report. Click on the single, which is on the printing area. Select the no. of copy  and click ‘ok’      

4.4         For Liquid Mode:

4.4.1    To clean the line, fill the sample compartment with distilled water and click on the pump and stirrer.

4.4.2    Click on the flow valve to open the outflow valve to remove the water from the sample compartment. And repeat the same operation for 2-3 times.

4.4.3 After completion of the cleaning fill the sample compartment with sample which is prepared in liquid and start the pump and stirrer.

4.4.4        Click on the measuring icon and fill the required data. Specified the time for measuring     (60 seconds).

4.4.5        Click on the ‘Background Measurement’ and measure the background and wait till highlight the sample measurement icon. (First laser is stabilized than acquisition count will be started)

4.4.6     Click on the sample measurement icon and wait for result.

4.4.7    After the completion of the measurement click on the valve icon to open the out flow valve to discard the sample. And clean the line with water for 2-3 times as per 4.4.1-4.4.2.

4.4.8        To print the results of the measurement of sample, click on the results icon and press the space bar key to select the report. Click on the single, which is on the printing area. Select the no. of copy  and click ‘ok’      

4.4.9        After completion of the test click on ‘exit’ icon to exit from the software and switch off the instrument and shutdown the computer.

4.4.10    Record the usage log of the instrument in instrument usage log book (Annexure-1)

5.0        Precaution:

5.1              After switching the power ‘ON’, allow sufficient time for the instrument to stabilize.

5.2              In case of wet dispersion, check that air bubbles are absent in the dispersion liquid.

5.3              In the case of dry dispersion, check visually or by inspection of subsequent obscuration values that the dosing unit for the disperser generates a steady mass flow.

6.0        Routine Maintenance:

6.1              Clean the instrument with dry cloth.

6.2              Clean the liquid sample compartment with water and dry powder compartment with tissue paper.

6.3.      Clean the line with water in liquid mode and with vaccum in dry mode

7.0        Document:

Annexure-1     Instrument usage log book                              XXX/FRM/000

8.0         History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision

Annexure – 1
Date	Name of Sample	A. R. No.	B. No.	Used by	Remark
SOP No. : XXX/SOP/000-00         Format No. : XXX/FRM/000-00