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SOP for Calibration of Coulter Counter


Standard operating procedure to calibrate the 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 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 following.
       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 on 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                                                                                                     
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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