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 37^oC. Press the enter key.

6.4.3        Allow the temperature to reach to 37^oC.

6.4.4        When the display shows the temperature 37^oC, 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 37^oC±2^oC.

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