Calibration of Centrifuge Apparatus : Pharmaceutical Guidelines

Calibration of Centrifuge Apparatus

Learn how to verify the performance of centrifuge apparatus using calibrated tachometer, digital thermometer and stop watch.

PROCEDURE

  • Ensure that all connection of instrument are proper
  • Operate the instrument as per the operating instructions
  • Use duly calibrated tachometer, digital thermometer and stopwatch during calibration of the equipment.

Calibration of time

  • Set the time for five minutes using set parameters. Record the results by using a digital stopwatch. Repeat the test for ten minutes.
  • Calibration of revolutions per minutes (RPM)

Fixed angle rotor

  • Set the RPM of rotor to 12000. Record the results by using tachometers.
  • Set RPM of rotor to 6000. Record the results by using tachometers

Swing out rotor

  • Set the RPM of rotor to 4000. Record the results by using tachometers.
  • Set RPM of rotor to 2000. Record the results by using tachometers.

Calibration of temperature

Fixed angle rotor

  • Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 5°C, RPM: 12000 and time 45 minutes.
  • Record the temperature of the sample solution by using digital thermometer.
  • Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 10°C, RPM: 12000 and time 45 minutes. Record the temperature of the sample solution by using digital thermometer
  • Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 20°C, RPM: 12000 and time 45 minutes. Record the temperature of the sample solution by using digital thermometer

Swing out rotor

  • Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 5°C, RPM: 4000 and time 45 minutes.
  • Record the temperature of the sample solution by using digital thermometer.
  • Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 10°C, RPM: 4000 and time 45 minutes. Record the temperature of the sample solution by using digital thermometer
  • Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 20°C, RPM: 4000 and time 45 minutes. Record the temperature of the sample solution by using digital thermometer

Frequency

Perform the calibration after every six months. Record the results in the calibration record format.

Maintenance and cleaning

  • Only neutral agents may be used for cleaning and disinfection (70% isopropanol/ water mixture or an alcohol -based disinfectant)
  • After cleaning with detergent, the rubber seals in the rotor chamber should be rinsed well in water and lubricated with glycerin in order to prevent the seals from becoming brittle.
  • If condensation water forms in the rotor chamber after freezing occurs, dry with a soft absorbent cloth.
  • The rotor and bucket must be cleaned regularly to prevent contamination caused by residue.
  • When instrument does not comply with the specified limits the instrument should be labeled as “out of calibration” and should get repaired /serviced.
  • After servicing /repairing the instrument must be calibrated as per above-mentioned procedure.

QUALITY ASSURANCE DEPARTMENT
CALIBRATION RECORD FOR THE EPPENDORF CENTRIFUGE MACHINE 
Page 1 of 2
SOP Reference     :
Date
:
Instrument No.    
Frequency
: Every six months
Make                      : 
Model
: 
Rotor Type Used : Swing Out Rotor
A] Speed Measurement
Instrument Used : Digital Tachometer (Non contact Version)
Sr. No.
RPM Set
RPM on Display
RPM on Tachometer
Tolerance RPM
1
4000


±100
2
2000


±100
Remark : Satisfactory / Not satisfactory.
Performed by :                                                                 Checked by:
Date :                                                                                Date           : 
B] Temperature Measurement
Instrument Used : Digital Thermometer
Sr. No.
Temp Set (°C)
Temp on Display (°C)
Temp on Thermometer (°C)
Tolerance (°C)
1
5


±2
2
10


±2
Remark : Satisfactory / Not satisfactory.
Performed by :                                                                 Checked by:
Date :                                                                                Date           : 
C] Time Measurement :
Instrument used : Stop Watch
Sr. No.
Time Set (Min.)
Time on Display (Min.)
Time on Stop watch (Min.)
Tolerance (Min.)
1
5


±2
2
10


±2
Remark : Satisfactory / Not satisfactory.
Performed by :                                                                 Checked by:
Date :                                                                                Date           : 








QUALITY ASSURANCE DEPARTMENT
CALIBRATION RECORD FOR THE EPPENDORF CENTRIFUGE MACHINE 
Page 2 of 2
SOP Reference     :
Date
:
Instrument No.     : 
Frequency
: Every six months
Make                    : 
Model
Rotor Type Used : Fixed Angle Rotor
A] Speed Measurement
Instrument Used : Digital Tachometer (Non contact Version)
Sr. No.
RPM Set
RPM on Display
RPM on Tachometer
Tolerance RPM
1
12000


±100
2
6000


±100
Remark : Satisfactory / Not satisfactory.
Performed by :                                                                 Checked by:
Date :                                                                               Date           : 
B] Temperature Measurement
Instrument Used : Digital Thermometer
Sr. No.
Temp Set (°C)
Temp on Display (°C)
Temp on Thermometer (°C)
Tolerance (°C)
1
5


±2
2
10


±2
3
20


±2
Remark : Satisfactory / Not satisfactory.
Performed by :                                                                 Checked by:
Date :                                                                               Date           : 
C] Time Measurement :
Instrument used : Stop Watch
Sr. No.
Time Set (Min.)
Time on Display (Min.)
Time on Stop watch (Min.)
Tolerance (Min.)
1
5


±2
2
10


±2
Remark : Satisfactory / Not satisfactory.
Performed by :                                                                 Checked by:
Date :                                                                               Date           : 
Conclusion : Instrument working is Satisfactory / Not satisfactory.
Next calibration due on :
Performed by :
Date :
Checked by :
Date :





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.
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