Calibration of Oven , Purpose :
Calibration of Oven , The purpose of this SOP is to describe the operation, calibration and cleaning of Oven (256 L) (Brand: Memmert, Model: UNE 600) used for drying of glassware in the quality control laboratory at XX Pharmaceuticals Ltd.
Calibration of Oven , Scope :
This SOP applies for operation, cleaning and calibration of Oven (256 L) (Brand: Memmert, Model: UNE 600) in quality control laboratory of XX Pharmaceuticals Ltd.
Definitions/Abbreviation:
Standard Operating Procedure (SOP): Standard Operating Procedure.
Responsibilities:
The roles and responsibility is as follows:
Sr. Executive/Executive, Quality Control
[][]To follow the instructions of this procedure correctly.
[][]To maintain the records properly as per SOP.
Manager, Quality Control
[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[][]Schedule calibration of the instrument at the defined intervals.
Manager, Quality Control
[][]Approval of SOP
[][]To ensure the overall implementation of the SOP.
Annexure:
N/A
Procedure:
General Precaution(s):
[][]Do not wipe with damped cloth at on position.
[][]Do not overload the chamber with glassware.
[][]Do not keep the items those may produce inflammation with air.
[][]Keep glassware to avoid the touch of inner surface of the chamber.
[][]Avoid opening the door for long period.
[][]Do not move the oven at on position. Severe vibrations may cause serious damage of the temperature probes.
Operation:
[][]Connect the instrument to the main power supply.
[][]Switch ‘ON’ the mains.
[][]Press push/turn control key to put on the main power switch in front of the instrument. The oven will start in normal mode with the display of timer, the chamber temperature, alarm temperature (red color indication).
[][]Hold down the SET key and turn the push/turn control key at the clockwise or anti clockwise for setting date, local time, operating temperature, alarm temperature. After setting, SET key will be released the display briefly flashes the set point.
[][]The display then changes to the actual current temperature and starts to the setting temperature. The temperature will be automatically increased at setting temperature and display the setting temperature digitally.
[][]Observe the display temperature until stable position.
[][]Hold down the SET key (appr. 3 seconds) to select the operation mode, if require. The current operating mode will be flashed on the display. There are three operating mode in the oven:
Normal Operation
Weekly Programmer
Ramp time Programme Operation
[][]Select the required programme and set as per operation manual.
[][]Select the fan speed to set the air changes.
[][]Turn the push/turn control at clockwise until the fan symbol flashing to move the air slider opens and closes the air valve to control the supply and discharge of air.
[][]Check the chamber temperature using by a calibrated digital thermometer, when the setting Temperature reaches.
[][]Keep the glassware’s inside the oven.
[][]The oven will automatically control the Temperature.
[][]The instrument will automatically adjust the temperature. When the temperature exceed the setting temperature, “off” light will illuminate and if the temperature decrease the “on” light will illuminate.
Cleaning Procedure :
[][]Switch off the oven and disconnect the power plug.
[][]Remove all glassware’s from the chamber of oven.
[][]Clean inside & outside of the chamber with dry cloth.
[][]Reload all items into the chamber when reach to dry the chamber surface.
[][]At the end of cleaning, connect the power plug and switch on the oven.
[][]Clean the chamber once in a month.
[][]Clean the outer surface of the oven every day.
Calibration Procedure:
[][]Switch ‘ON’ the mains of instrument.
[][]Set the desired temperature. Follow above operation procedure
[][]Allow sufficient time to equilibrate the set temperature.
[][]Check the temperature using a calibrated thermometer/data logger and record the temperature in the calibration certificate as per Annexure-V of Engineering SOP
[][]Carry out others two calibration temperatures in the same manner.
[][]Calibrate the oven once in a year ± 15 days.
Maintenance :
[][]If oven shows any mechanical, electrical or any others problem, inform to supplier or Engineering Department for corrective action.
[][]After corrective action, recalibrate the oven if it is necessary.