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
OBSERVATIONS:
1. Calibration
for temperature maintenance:
Temperature setting:
37oC.
Limit:
Beaker 1: 35oC
to 39oC
Beaker 2:
35oC to 39oC
2. Calibration
of number of cycles per minute:
Limit: 29
to 32 cycles/ minute.
3. Calibration
of distance travelled:
Limit: 55±2mm.
Conclusion:
Satisfactory/ Not satisfactory.
|
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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