Operation And Calibration Of Liquid Particle Counter

1.0              OBJECTIVE:

           

The objective of this SOP is: To describe the procedure for operation of Liquid Particle Counter.

2.0              RESPONSIBILITY:

2.1               The Quality Control – Chemist shall be:

2.1.1.        Responsible for operating the liquid particle counter as per the SOP.

2.2               The Executive – Quality Control shall be:

2.2.1          Responsible for ensuring the adherence of SOP

3.0              ACCOUNTABILITY

Head - Quality Control

4.0              PROCEDURE

4.1              Operating Procedure:

4.1.1          Power ‘ON’ the equipment to get sterilize.

4.1.2          Turn ‘ON’ the computer.

4.1.3          Double click on the Pharm spec V 1.4 icon.

4.1.4          Then put operator name and Password.

4.1.5          Click set up icon and go to the sample control menu.

4.1.6          Click the Prime to rinsing the syringe and menu Arm Up.

4.1.7          Click exit to come out of main menu.

4.1.8          Again press setup menu and press sample identification menu.

4.1.9          Type in the sample identification:  sample name, Batch No., Batch Size, Date, Analyst. Etc..

4.1.10      As per requirement, then press OK to save the information.

4.1.11      Then  press  USP<788>.

4.1.12      Then select Small Volume Injection (SVI) Test or Large volume Injection (LVI) test as per requirement.

4.1.13      For SVI test type number of containers and total volume of containers (Total volume of sample: Minimum 30 ml).

4.1.14      Then click “Run” counter to analysis the sample.

4.2              Calibration Procedure:

4.1.15      Calibration of the Liquid particle counter shall be done with co-ordination of an Approved external Agency.

Frequency:   Once in a year