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1.0 OBJECTIVE : To provide guidelines for the calibration of the Thermometer/Clock/Humidity Meters & Data Loggers.
2.0 SCOPE : This procedure is applicable for the calibration of all the Thermometer/Clock/Humidity Meters & Data Loggers used for monitoring & recording the temperature & humidity.
3.0 RESPONSIBILITY
3.1 QC Officer/Engineering Officer shall carry out the activity as per the procedure described in this SOP.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his/her designee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Perform the calibration of the Thermometer/Clock/Humidity Meters & Data Loggers within due time.
5.2 During Calibration of the Thermometer/Clock/Humidity Meters & Data Loggers using calibrated stability chamber as a controlled environment, make sure that the doors of the stability chambers are not kept opened for longer time.
6.0 PROCEDURE
6.1 Procedure for calibration of the Thermometer/Clock/Humidity Meter
6.1.1 Use calibrated Data logger / Thermo-Hygrometer as reference to perform the calibration of the Thermometer / Clock / Humidity Meters.
6.1.2 Perform calibration of the test Thermometer/Clock/Humidity Meter using calibrated stability chambers of condition 25°C + 2°C/60%RH + 5%RH, 30°C + 2°C/65%RH + 5%RH and 40°C + 2°C/75%RH + 5%RH as controlled environment.
6.1.3 Before placing the reference Data logger inside the stability chamber, set the program of the data logger to record data every after 20 minutes.
6.1.4 Place the reference data logger or thermo-hygrometer inside the stability chamber with condition 25°C + 2°C/60%RH + 5%RH. At the same time place the test Thermometer / Clock /Humidity Meter, inside the stability chamber.
6.1.5 Wait for 1 hour, then record the Temperature & Humidity readings of the test Thermometer /Clock/Humidity Meter for 3 consecutive readings at 20 minutes interval.
6.1.6 Record the readings in such a way that it matches with the record time of the reference data logger.
6.1.7 After recording the readings in the first chamber, place the reference Data Logger & test Thermometer / Clock/Humidity Meter in the second chamber with condition 30°C + 2°C/65%RH + 5%RH.
6.1.8 Wait for 1 hour, then record the readings of Temperature & Humidity of the test Thermometer /Clock/Humidity Meter.
6.1.9 Similarly, place the reference Data Logger & test Thermometer / Clock/Humidity Meter in the third chamber and record the readings after 1 hour.
6.1.10 Record the readings in Annexure – I (FRM No. FQC/304).
6.1.11 Frequency of calibration: Yearly + 15 days.
6.2 Procedure for calibration of the Data Logger:
6.2.1 Use a calibrated & certified Data Logger as a reference one (either in-house or rented from an existing supplier who has agreement with BPL to provide services in the same field). The validity of calibration of the reference data logger has to be ensured.
6.2.2 Firstly, place the probe (s) of the certified data logger in different positions of the selected refrigerator with temperature – 20°C. At the same time, place the data loggers to be calibrated inside the same refrigerator.
6.2.3 Collect data for 1 hour at an interval of 5 minutes and download the data and take print out.
6.2.4 Then, place the probe (s) of the reference data logger and the data loggers to be Calibrated in a refrigerator with temperature 2-8°C and collect data for 1 hour at an interval of 5 minutes and download the data and take print out.
6.2.6 Finally, place the probe (s) of the reference data logger and the data loggers to be calibrated in stability chambers with conditions 25°C + 2°C/60%RH + 5%RH, 30°C + 2°C/65%RH + 5%RH and 40°C + 2°C/75%RH + 5%RH one after another and similarly collect data for 1 hour (in each condition) at an interval of 5 minutes and download the data and take print out.
6.2.7 Record the readings of the reference data logger and the test data loggers in Annexure-II (FRM No.: FQC/333).
6.2.8 Frequency of calibration: Yearly + 15 days.
6.3 In case any thermometer/ clock/humidity meter or data logger fails to meet the calibration requirement, it has to be discarded immediately replacing with a new one.
