Follow
1.0 OBJECTIVE
To set up a procedure for the operation, cleaning and calibration of Refrigerator.
2.0 SCOPE
This SOP is applicable for the operation, cleaning and calibration of Refrigerator-IV, ID.: QC/223 (Berjaya, Model No. XR30CX), of Quality Control Laboratory (F-2) of (Company Name).
3.0 RESPONSIBILITY
3.1 QC Officers / Analysts are responsible for carrying out the procedure.
3.2 Overall responsibility for training, implementation and follow-up with the QC Manager or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Never unplug the refrigerator by pulling on the power cord. Always grip the plug firmly and pull straight out from the outlet.
5.2 Do not plug in any other appliance at the same power point as the refrigerator or use extension cords or double adapters.
5.3 Never store volatile or flammable materials in the refrigerator or freezer as they may explode.
5.4 Do not keep the door of the refrigerator opened for more than 1.5 min.
6.0 PROCEDURE
6.1 Operation
6.1.1 Plug the refrigerator to the mains. Turn on the power at the wall socket.
6.1.2 Push the ON/OFF key, the instrument is switched on. To switch the instrument off push again the ON/OFF key.
6.1.2 Open the door of Refrigerator after switching on the light.
6.1.3 Keep the materials (reference standard, working standard, stability sample, standard solution/samples as per requirement) on the trays / racks in orderly manner avoiding mix-ups of sample vials.
6.1.4 Close the door.
6.1.5 Changing the set point
6.1.5.1 Push he set key for more than 2 sec to change the set point value.
6.1.5.2 The value of the set point will be displayed and the “°C” or °F” LED starts blinking
6.1.5.3 To change the set value push the up and down arrow keys within 10 sec.
6.1.5.4 To memories the new set point value push the SET key again or wait 10 sec.
6.1.6 Checking of set point
6.1.6.1 Push the SET key, the display will show the set point value.
6.1.6.2 Push and immediately release the SET key and wait for 5 sec to display the probe value again.
6.1.7 If required, push the DEF key for more than 2 sec and a manual defrost will start.
6.2 Monitoring of daily temperature
6.2.1 Place the probe of certified digital thermometer in the middle compartment of the Refrigerator.
6.2.2 Record the temperature (actual, maximum and minimum) twice daily in Temperature Register as per Annexure-I (FRM No.: FQC/066).
6.2.3 The Temperature Register (FRM No.: FQC/066) contains Instrument name, Instrument ID, Location, Thermometer ID No. should be pre-printed for the refrigerator.
6.3 Cleaning
6.3.1 Wipe over the interior surfaces with soft lint free cloth.
6.3.2 Clean exterior surfaces with soft lint free cloth. If needed moisten the cloth with warm water and detergent.
6.3.3 Do not use harsh, abrasive cloths or cleaners or highly perfumed, strong smelling cleaners or solvents on any part of the refrigerator.
6.3.4 It is important when cleaning the exterior door surface of refrigerator, to only use liquid dishwashing detergent dissolved in warm water.
6.3.5 Dry the door with a clean, lint free cloth. The use of abrasive or stainless steel cleaners and solvents will damage the door surface.
6.3.6 Clean the shelves and bottle rack with soft lint free cloth
6.4 Calibration
6.4.1 Temperature Mapping
6.4.1.1 Uniformity of temperature in the refrigerator should be checked by placing sufficient number (As designated in the validation validation program) of calibrated data loggers in the different positions of the shelves inside the refrigerator.
6.4.1.2 The data loggers to be placed in the positions programming to record data at a defined interval. After completion of the data recording for one hour, take out the data loggers and print the data and transfer data of 10 min, 20 min, 30 min, & 60 min to Annexure-II (FRM No. FQC/617-00)
6.4.1.3 Repeat the above at empty, minimum load and maximum load condition (During initial qualification).
6.4.1.4 During routine qualification (once in a year) the temperature mapping shall be done at as it is condition following steps 6.4.1.1 & 6.4.1.2 with recording data every after 30 minute up to 24 hours and reporting shall be done as per pre-approved protocol for each qualification.
6.4.1.5 Acceptance Criteria:
The temperature in all points should be stable (Variation between 6 readings of each data logger : within +1.0°C).
Uniformity of temperature in all points should be within ± 2.0ºC.
Accuracy of Temperature within the refrigerator should be: set point + 3°C.
6.4.2 Frequency : Routine qualification shall be done once in a year ± 15 days of due date.
