Follow
1.0 OBJECTIVE : To set up a procedure for the calibration of Incubators.
2.0 SCOPE : This SOP is applicable for calibration of Incubator I, II and III in Quality Control Department of (Company Name).
3.0 RESPONSIBILITY
3.1 QC Officer/Analyst shall carry out the activity as per procedure.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Ensure proper earthing.
5.2 Ensure 230 volts AC stabilized power supply to the system.
5.3 Ensure the door is properly closed while running the incubator.
5.4 Do not change the internal parameters of the controller, which might change the calibration.
5.5 Do not keep the incubator in high temperature area.
5.6 Do not keep the incubator near the back wall. At least 2 feet clear distance should be provided from all sides of the incubator.
6.0 PROCEDURE
6.1 Data Logger / Certified calibrator (Calibrated temperature indicator) is used to perform the calibration.
6.2 Make sure that the incubator is off. Open the validation port at the right side of the incubator. Insert the eight temperature probe of the calibrator through this port into the incubator.
6.3 Open the door of the incubator. Set the probes at the eight defined places into the incubator. Connect the calibrator to the mains. Close the door.
6.4 Keep a printer near the calibrator (It is recommended to use LX-300 Epson Dot Matrix printer). Connect the printer with the calibrator. Set papers as much as required. Connect the printer to power supply.
6.5 Connect the incubator to the mains.
6.6 Turn ON the switch of the incubator located on the upper right hand side of the instrument.
6.7 Set 33ºC temperature by pressing increment key () [to increase the temperature] or decrement key () [to decrease the temperature].
6.8 Move and fix the “Safety Thermostat” knob to the temperature same as that of the set temperature.
6.9 Allow sufficient time to reach the desired set temperature. When the temperature is reached to the desired level, switch on the calibrator.
6.10 Record the readings for the calibrator for about one hour.
6.11 Follow steps 6.8 to 6.11 for the other 43ºC and 36 º C temperatures.
6.12 Print the data. Keep the records of calibration with printout as per Annexure-I.
6.13 Affix a calibration sticker on the door of the instrument.
6.14 Acceptance Limit: Set Temperature ± 1°C.
6.15 Frequency of Calibration : One year ± 15 days.
