SOP for Calibration of Coulter Counter

1.0 OBJECTIVE

To calibrate the equipment for reliable and accurate results.

2.0 SCOPE

This procedure is applicable to calibrate the coulter counter installed in the quality control department.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

Frequency: Once in a three month
5.1 Program and operate the instrument as per SOP.
5.2 Use the ‘menu cursor’ keys to select the following option on the ‘SET UP’ menu.
5.3 Set the parameters as follows.
Orifice size :70 & 100 µ alternately
Diameter/Length: Enter the aperture diameter and length of the orifice tube selected for calibration.
Set up: Select 'Automatic'
Analysis: Select 'Sample'
Calibration: Select 'New'
Size: Enter the (number mode) of the latex particles used for calibration and the assay Diameter of the chosen latex size should be 20 % of the aperture diameter for optimum results.(e.g. 2.15 E1 means 21.5 m)
Size units: Select mm
5.4 Select ‘FULL RANGE’.
5.4.1 X-Axis ----> Select ‘Lin Dia’.
5.4.2 Y-Axis ----> Select ‘Number Diff’.
5.4.3 Blank subtract ---> Select No.
5.4.4 Channels-----> 256
5.4.5 Channel data --> No.
5.5 Observe reading as per S.O.P.
5.5.1 Move the upper and lower cursor to coincide with peak height.
5.5.2 Press SET UP key and select record on the calibration line on SET UP menu.
5.5.3 The new Kd factor will display .
5.5.4 Press the CAL key, the instrument is now calibrated for that electrolyte solution and orifice tube for diameter and volume.
5.5.5 Print the graph and set up menu with new Kd factor for recording. Record the observation as per annnexure. If calibration is out of limit, follow the S.O.P.

6.0 ABBREVIATIONS

6.1 No.= Number
6.2 Lin.Dia.= Linear diameter
6.3 Diff = Difference
6.4 mm= Micrometer
6.5 m= Micron

ANNEXURE-I

Q. C. DEPARTMENT

CALIBRATION REPORT OF COULTER COUNTER

CALIBRATION  DATE	DATE OF LAST CALIBRATION DONE	NEXT DUE FOR CALIBRATION

INSTRUMENT DETAILS
INSTRUMENT NAME	INSTRUMENT MAKE	INSTRUMENT IDENTIFICATION NO.

Name of std. Calibration solution  : CC standard L5 Polystyrene Latex

Lot No.                                        :

Size of Latex particles                   : 

Conductivity fluid                          : Filtered N.Saline

Label claim                                   :

For 70µm aperture diameter          : 3 drops per 50ml

For 100µm aperture diameter        : 3 drops per 50ml

OBSERVATION

Orifice Diameter     Observed Kd value                                       Limit of  Kd value

70 microns                                                                                  677+/-10%

100 microns                                                                                930 +/- 10%

Orifice Diameter     Observed diameter of latex particles used      Limit of  latex particles

70 microns                                                                                  +/- 2 % of label claim. (Limit:     to     µm)

100 microns                                                                                                     

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