Disintegration apparatus Calibration SOP


1.0  OBJECTIVE:
To lay down the calibration procedure of Disintegration apparatus.
2.0  SCOPE:
This shall be applicable to the Disintegration apparatus of Quality Control Instrument Laboratory.
3.0  RESPONSIBILITY:
3.1  Technical Assistant/ Helper.
3.2  Q.C Analyst.
4.0  ACCOUNTABILITY:
4.1  Manager-Quality Control.
5.0  MATERIAL AND EQUIPMENT:
5.1  Disintegration apparatus.
5.2  Calibrated thermometer.
5.3  Calibrated scale.
6.0  PROCEDURE:
6.1  Switch ON the mains.
6.2  Operate the apparatus according to SOP.
6.3  Calibration of number of cycles per minute:
6.3.1        Press the start key once to start the test.
6.3.2        Note the number of cycles in one minute.
6.3.3        Repeat the test 4 times to confirm the results. And record in Annexure-1.
6.3.4        Results are found satisfactory if the number of cycles per minute is in between 28-32.
6.4  Calibration for temperature maintenance:
6.4.1        Ensure that the beakers are filled with purified water.
6.4.2        Press the ’Set’ & ‘Temp’ key and set the temperature at 37oC. Press the enter key.
6.4.3        Allow the temperature to reach to 37oC.
6.4.4        When the display shows the temperature 37oC, insert one calibrated thermometer into the beaker.
6.4.5        Note down the reading. 
6.4.6        Repeat the test 4 times to confirm the results. And record in Annexure-1.
6.4.7        Results are found satisfactory if the temperature lies between 37oC±2oC.
6.5  Calibration of distance travelled:
6.5.1        Press the start key once to start the test.
6.5.2        Note the travelling distance of the basket rack assembly on the device from a calibrated scale.
6.5.3        Repeat the test 4 times to confirm the results. And record in Annexure-1.
6.5.4        Results are found satisfactory if the distance travelled is between 53 to 57mm.
6.6  Record the result on the “Calibration Record”, “Calibration Log Book” & paste the “Calibration Status Sticker” on Disintegration apparatus.
6.7  If the results are found unsatisfactory, put ‘Out of order’ tag on the instrument. Inform the same to engineering dept./ manufacturer for repair.
7.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

8.0  REFERENCES:
8.1  Not Applicable.
9.0  ANNEXURES:
Annexure 1: Calibration report of Disintegration apparatus.







Annexure: 1
CALIBRATION REPORT OF DISINTEGRATION APPARATUS
Calibration report of Disintegration Apparatus
Calibration date
Date of last calibration done
Next due for calibration



INSTRUMENT DETAILS:
Instrument name
Instrument make
Instrument identification no.




OBSERVATIONS:
1.      Calibration for temperature maintenance:
Temperature setting: 37oC.
Sr.#
Observed temperature
Remarks
Beaker 1
Beaker 2

















Limit:
Beaker 1: 35oC to 39oC
Beaker 2: 35oC to 39oC




2.      Calibration of number of cycles per minute:
Sr.#
Observed up/down (cycles/ minute)
Remarks













Limit: 29 to 32 cycles/ minute.

3.      Calibration of distance travelled:
Sr.#
Observed oscillation
Remarks
Arm 1
Arm 2

















Limit: 55±2mm.

Conclusion: Satisfactory/ Not satisfactory.


Done by/date
Checked by/date





10.0    ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Q.C
Quality control
Q.A
Quality assurance
QCEB
Quality control equipment calibration
F
Format
g
Grams
Kg
Kilograms
mm
Millimeters
%
Percentage
Sr.#
Serial number


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