To lay down the procedure for operation and calibration of Environmental / Humidity chambers
1.0 PURPOSE
To lay down the procedure for operation and calibration of Environmental / Humidity chambers.
2.0 SCOPE
2.1 This SOP is applicable for Environmental / Humidity Chambers in QC Laboratories.
3.0 RESPONSIBILITY
3.1 Executive-QC
4.0 ACCOUNTABILITY
4.1 Asst. Manager-QC
5.0 OPERATIONAL PROCEDURE
5.1 Operational procedure for Humidity / Walk-in chamber:
5.1.1 Ensure that the electrical supply and purified water supply is given to the chamber.
5.1.2 Switch on the power supply followed by the Main switch.
5.1.3 Operation of Temperature Indicator:
5.1.3.1 To unlock the keypad, Press the “SEL” button for one sec, Press ‘?’?and ‘?’ keys to select the “LoC”, press again on “SEL” button to change the key lock status. Press ‘?’ until it displays “0”. Press “SEL” button to for one sec to conform the change.
5.1.3.2 Set the temperature by pressing ‘?’?and ‘?’ keys provided on the Temperature indicator.
5.1.3.3 The bottom display will show the set temperature in green color and the top display will show the actual temperature maintaining inside in red color.
5.1.3.4 To Lock the keypad, Press the “SEL” button for one sec, Press ‘?’?and ‘?’ keys to select the “LoC”, press again on “SEL” button to change the key lock status. Press ‘?’ until it displays “0”. Press “SEL” button to for one sec to conform the change.
5.1.4 Operation of Humidity Indicator:
5.1.4.1 To unlock the keypad, Press the “SEL” button for one sec, Press ‘?’?and ‘?’ keys to select the “LoC”, press again on “SEL” button to change the key lock status. Press ‘?’ until it displays “0”. Press “SEL” button to for one sec to conform the change.
5.1.4.2 Set the Humidity by pressing ‘?’?and ‘?’ keys provided on the Humidity indicator.
5.1.4.3 The bottom display will show the set humidity in green color and the top display will show the actual humidity maintaining inside in red color.
5.1.4.4 To Lock the keypad, Press the “SEL” button for one sec, Press ‘?’?and ‘?’ keys to select the “LoC”, press again on “SEL” button to change the key lock status. Press ‘?’ until it displays “0”. Press “SEL” button to for one sec to conform the change.
5.1.5 Set the required temperature on the safety controller by pressing red button provided on the controller and by adjusting coarse and fine knobs.
5.2 Operation of cooling and Humidity system:
5.2.1 Switch on any one cooling system (Cooling 1 or Cooling 2 If there)
5.2.2 Switch on any one humidity system (Humidity 1 or Humidity 2 If there)
5.2.3 Change over to ‘Stand by system’ (if there):
5.2.4.1 Switch off the running cooling and humidity system.
5.2.4.2 Switch on the stand by cooling and humidity system.
5.3 Procedure for daily printouts of temperature & humidity records:
5.3.1 Through PC:
5.4.1.1 Ensure that the computer is ‘ON’.
5.4.1.2 Double click on the icon ‘Shortcut to Enviro” icon on the desktop.
5.4.1.3 “Stability Chamber Monitoring System” window will appear.
5.4.1.4 Ensure that the data download is in “Download ON” mode.
5.4.1.5 Select the Chamber Number.
5.4.1.6 Ensure that the printer is connected with the PC.
5.4.1.7 Ensure that the printer is ‘ON’ and stationary is attached to the printer.
5.4.1.8 Select the Time and Date.
5.4.1.9 Click ‘Report’.
5.4.1.10 Click ‘Print’ and ‘OK’.
5.4.1.11 Sign all the records and file appropriately.
5.4 Operation of Printer interface:
5.4.1 The Printer Interface shall be used to print the recorded data incase of any problem in software downloading.
5.4.2 Connect the printer card provide In the back side of the chamber.
5.4.3 Press ‘SEL’ key of Enviro provided in front side of the chamber
5.4.4 ‘Display No’ will display on the screen
5.4.5 Press ‘SEL’ again.
5.4.6 ‘Set time and date’ used to set time and date for requirement by using ‘up’ and horizontal key.
5.4.7 Press ‘SEL’
5.4.8 ‘Printer interval’ used to set the printer interval.
5.4.9 Press ‘SEL’
5.4.10 ‘Page LEN’ used to set the page length for printing.
5.4.11 Press ‘SEL’
5.4.12 ‘Print Page #’, Enter required page no and press enter key
5.4.13 Press ‘SEL’
5.4.14 ‘Set page’ will display.
5.4.15 Press ‘SEL’
5.4.16 ‘Password’ will display, then enter the password and press enter key.
5.4.17 ‘Log in ok’ will display.
5.4.18 The set value and actual value of temperature and humidity is also displayed on the PC/Printer interfacing box (ENVIRO).
5.5 Safety controller Alarm system:
5.5.1 Incase of any deviation from the set values of safety controller, the system beeps a Alarm and it gets trip off.
5.5.2 Press the reset button, to restart the chamber.
5.6 Safety precautions:
5.6.1 Keep the water level provided at the back of the Incubator by supplying fresh purified water continuously.
5.6.2 Do not use hard water for the boiler tank. The water should be Purified water.
5.6.3 Ensure that the electrical switches are grounded.
5.6.4 Check the chamber and condenser fan, if found loose, tighten it, also ensure the cleaning of these fans.
5.6.5 Check the working of the safety cut off alarming systems.
5.6.6 Keep the doors of the Incubator closed when not in use.
5.6.7 Inform immediately to the Maintenance Engineer in case of any break down.
5.6.8 Check the chamber and condenser fan, if found loose, tighten it, also ensure the cleaning of these fans.
5.6.9 Check the working of the safety cut off alarming systems.
5.6.10 Ensure that all the portholes and floor and door is closed while running the stability chamber.
5.6.11 The door shall not be opened for longer time, as this will affect the climatic conditions prevailing inside the chamber.
6.0 CALIBRATION PROCEDURE:
Calibration of Stability Chamber shall be performed by Instrument engineer / Third party as per the following procedure:
6.1 For Temperature and Relative Humidity Mapping in the Stability Chamber:
6.1.1 Use Master Calibrator that is certified by NIST or ERTL or NPL or ETDC equivalent authorities and the tracebility certificate should be obtained.
6.1.2 Distribute the sensors of Temperature and Humidity of Calibrator at different location of the Stability Chamber as described in the attached Diagram.
6.1.3 Set Temperature and Relative Humidity. Allow to stabilize to start recordings of Temperature and Relative Humidity of the Calibrator for the minimum period of 1 hour at a interval of not more than15 minutes.
6.1.4 Record the digital display readings for Temperature and Relative Humidity of the calibrator sensors in the attached format (QC048-F01).
6.1.5 Calculate the difference of Temperature and Relative Humidity of the Calibrator from set Temperature and Relative Humidity.
6.1.6 Acceptance Criteria: ± 2°C of Set Temperature and ± 5% of Set Relative Humidity.
6.1.7 Frequency: 1 year ± 30 Days
6.1.8 Certificate for Temperature and Relative Humidity mapping shall be prepared by Instrument Engineer / External Agency and the supporting data’s pertaining to above calibration/mapping shall also be maintained.
6.1.9 Certificate shall be authorized by Head Stability QC.
END OF THE DOCUMENT
Quality control, humidity chambers, operation, calibration
