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Centrifuge Machine Calibration SOP

Web of Pharma December 30, 2019

Centrifuge Machine Calibration SOP 

1.0  OBJECTIVE:
To lay down the calibration procedure of Centrifuge machine to provide a system to calibrate, control and maintain the equipment used for inspection measuring and test equipment in order to ensure the correctness of measurement and test status.
2.0  SCOPE:
This shall be applicable to the Centrifuge machine 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  Centrifuge machine.
5.2  Calibrated digital tachometer.
5.3  Calibrated digital thermometer.
5.4  Calibrated stop watch.
6.0  PROCEDURE:
6.1  Ensure that all the connections of instrument are proper.
6.2  Operate the instrument as per the operating instructions given in SOP.
6.3  Calibration of time:
6.3.1        Set the time for 5 minutes using set parameters.
6.3.2        Record the results by using digital stop watch.
6.3.3        Repeat the test for 10 minutes.
6.4  Calibration of revolution per minute:
6.4.1        Fixed angle rotor:
6.4.1.1  Set the RPM of rotor to 12000.
6.4.1.2  Record the results by using calibrated digital tachometer.
6.4.1.3  Repeat the test for 6000 RPM. Record the results.
6.4.2        Swing out rotor:
6.4.2.1  Set the RPM of rotor to 4000.
6.4.2.2  Record the results by using calibrated digital tachometer.
6.4.2.3  Repeat the test for 2000 RPM. Record the results.
6.5  Calibration of temperature:
6.5.1        Fixed angle rotor:
6.5.1.1  Fill the two sample tubes with ethylene glycol.
6.5.1.2  Place it in sample holder.
6.5.1.3   Set the parameters like temperature 5oC, 12000RPM and time 45 minutes.
6.5.1.4  Record temperature of the sample solution by using digital thermometer.
6.5.1.5  Similarly repeat the test for the 2nd parameters like temperature 10oC, 12000RPM and time 45 minutes. And 3rd the parameters like temperature 20oC, 12000RPM and time 45 minutes. And record the temperature of the sample solution respectively by using digital thermometer.
6.5.2        Swing out rotor:
6.5.2.1  Fill the two sample tubes with ethylene glycol.
6.5.2.2  Place it in sample holder.
6.5.2.3   Set the parameters like temperature 5oC, 4000RPM and time 45 minutes.
6.5.2.4  Record temperature of the sample solution by using digital thermometer.
6.5.2.5  Similarly repeat the test for the 2nd parameters like temperature 10oC, 4000RPM and time 45 minutes. And 3rd the parameters like temperature 20oC, 4000RPM and time 45 minutes. Record the results respectively.
6.6  Frequency:
6.6.1        Perform the calibration after every six months. Record the results in the calibration record format.
6.7  Record the result on the “Calibration Record”, “Calibration Log Book” & paste the “Calibration Status Sticker” on Centrifuge machine.
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 record of Centrifuge machine.


Annexure: 1
Calibration record of Centrifuge machine.
CALIBRATION RECORD OF CENTRIFUGE MACHINE
SOP Reference: _____________________

Calibration date
Date of last calibration done
Next due for calibration




Instrument details
Instrument name
Instrument make
Instrument identification No.



Location:

Frequency:


Rotor type used: Swing out rotor.
A.    Speed measurement (RPM):
Instrument used:
Calibrated digital tachometer.
Sr.#
RPM Set
RPM on Display
RPM on Tachometer
Tolerance RPM
Remarks
1.       
4000


±100

2.       
2000


±100








B.     Temperature measurement:
Instrument used:
Calibrated digital thermometer.
Sr.#
Temp Set
(oC)
Temp on Display
(oC)
Temp on Thermometer
(oC)
Tolerance (oC)
Remarks
1.       
5


±2

2.       
10


±2


C.    Time measurement
Instrument used:
Calibrated stop watch.
Sr.#
Time Set
(min)
Time on Display
(min)
Time on stop watch
(min)
Tolerance (min)
Remarks
1.       
5


±2

2.       
10


±2


Rotor type used: Fixed angle rotor.
A.    Speed measurement (RPM):
Instrument used:
Calibrated digital tachometer.
Sr.#
RPM Set
RPM on Display
RPM on Tachometer
Tolerance RPM
Remarks
1.       
12000


±100

2.       
6000


±100






B.     Temperature measurement:
Instrument used:
Calibrated digital thermometer.
Sr.#
Temp Set
(oC)
Temp on Display
(oC)
Temp on Thermometer
(oC)
Tolerance (oC)
Remarks
1.       
5


±2

2.       
10


±2

3.       
20


±2


C.    Time measurement
Instrument used:
Calibrated stop watch.
Sr.#
Time Set
(min)
Time on Display
(min)
Time on stop watch
(min)
Tolerance (min)
Remarks
3.       
5


±2

4.       
10


±2






Remarks: The calibration procedure of instrument is within tolerance limit and gives satisfactory/ not satisfactory results.

Calibration 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
oC
Degree centigrade
min
Minutes
RPM
Revolution per minute


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