SOP on Operation, Maintenance& Calibration of Incubator

SOP on Operation, Maintenance& Calibration of Incubator

1.0 Purpose: This SOP explains the operation, maintenance and calibration of incubator.
2.0 Scope: This SOP is for the incubator located in ther Quality Control laboratory. 

3.0 Responsibility: 

3.1 The Quality Control microbiology department is responsible for the correct operation, routine maintenance or setting, and cleaning and disinfecting of the incubator, and recording all operations in the incubator log. The Qaulity Control microbiologist is responsible for ensuring these procedures are followed.
3.2 The maintenance department is responsible for making adjustments and repairs to the incubator and for recording them in the maintenance log.
3.3 Quality Assurance must be notified of any repairs via an incident / deviation report.
3.4Quality Assurance is responsible for performing the yearly calibrations and for assessing the need for revalidations after repairs.
4.0 Materials and Equipment: 

 Incubator, model, serial no.
 Thermometer (certified), model / manufacturer / range
 Cleaning solutions
 Traceable reference thermometer
 Maintenance log
5.0 Procedure:

5.1.0 Operation – 

5.1.1 Turn on power.
5.1.2 Set temperature.
5.1.3 Let temperature stable for 60 minutes.
5.1.4 Set high limit thermostat.
5.2.0 Temperature Verification (every day)
5.2.1 Check the calibration date of certified thermometer. 
5.2.2 Check the temperature on the digital read out and with the certified thermometer and record in the incubator log book
5.2.3 Notify supervisor and engineering department
a. if digital readout and thermometer temperature differ by > 0.50C.
b. if thermometer is outside the accepted range specified on the incubator.
5.3.0 Maintenance (monthly) 
5.3.1 Prepare a solution of the cleaning reagent.
5.3.2 Wash interior surfaces and shelves.
5.4.0 Calibration (once a year Quality Assurance will calibrate the incubator at 3 different temperatures e.g. 250, 350, 450.
5.4.1 Set the first calibration temperature.
5.4.2 Place the thermometer in the center of the incubator ensuring the bulb does not touch the shelves.
5.4.3 Wait 60 minutes for the incubator temperature to stabilize.
5.4.4 Compare the reading on the reference thermometer with the digital display.
5.4.5 If there is a difference – Put the display into calibration mode by rotating the knob. Allow the incubator temperature to stabilize and repeat step 5.4.4.
5.4.6 Repeat section 5.4.1 to 5.4.5 for two other temperatures.
6.0 Reporting: 

6.1 Record each use in the incubator (date, time, temperature). All samples in the incubator must be clearly marked. 
6.2 Record maintenance information and calibration data in the log (date, time, cleaning solution, operator).
6.3 Record all calibration data in the incubator log (date, time, set temperature, digital temperature, thermometer temperature, and operator).
6.4 Report all problems in the operation of the incubator immediately to the supervisor.
6.5 Update calibration sticker.

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