Calibration of Centrifuge Apparatus : Pharmaguideline

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.

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)

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

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

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

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 :