SOP-Operation and Calibration of Stability Chambers

This Document describes (Standard Operating procedure) Sop for Operation and Calibration of Stability Chambers.

Sop for Operation and Calibration of Stability Chambers.

I. Purpose & Scope:

• The Purpose of this SOP is to lay down the procedure for Operation and Calibration of Stability Chambers .
• This procedure is applicable for operation and calibration of Stability Chambers used in Quality Control Department

II. Responsibilities:

• All Quality Control personnel shall be responsible to follow and implement this SOP i.e. Operation and Calibration of Stability Chambers.

III : Introduction and Procedural Part:

Operation and Calibration of Stability Chambers:

Precautions:

• Ensure that the stability chamber is clean.
• Ensure the calibration status of temperature and humidity sensor is within its calibration period
• Ensure continuous water supply to the boiler reservoir tank.
• Do not use the hard water for the boiler tank, the water should be demineralised water.
• Ensure that the port holes & door is closed while running the chamber.
• Do not keep chamber in high temperature area, the chamber should be kept in an Air Condition room or in a well ventilated room.
• Do not keep the chamber near the back wall.
• Do not change the internal parameter of the controller .
• Check continuous water supply to the boiler reservoir tank.
• Check that the port hole & door is closed.
• Check that the conditioning duct is provided at the back side of main working area which consists of a cooling coil, air heaters, circulating blower & motor arrangement.
• Switch on the main power supply & switch on the power which provided on the front side of humidity chamber.
• All the below points will be on when the main switch is ON
  • • Display on temperature control.
    • Display on humidity control
    • Display on safety control
    • Display on P.C./Printer interfacing box.
    • Inside chamber motor ON.

Operating Procedure :

• Put “ON” the mains on the switch board.
• Put “ON” the mains on the control panel of the stability chamber. This will give display on temperature and humidity controller, display on safety controller, inside the chamber motor “ON”, display on printer interface “ON”.
• Set the desired temperature on temperature controller by pressing increment and decrement key, which will display the set point. The bottom display will show the set temperature and top display will show the actual temperature.
• Set the desired humidity on the humidity controller. Similarly do the same for temperature controller.
• Set the safety controller with same set temperature as that set on the temperature controller.
• The set temperature of safety controller should be set same as that of temp. on the temp. Controller.
• Set the alarm band ± 2⁰C of set temp and ± 5% of set RH. The safety controller will cut off the mains contactor in case over shoot or under shoot of the temperature above alarm band. Also it will cut off the supply in case of inadequate water supply to boiler tank.
• Put “ON” the cooling switch of the control panel. This will start the condenser motor and compressor.
• Put “ON” humidity switch of the control panel. This will start the boiler heater.
• Ensure that temperature and humidity is reached as desired.
• The stability chambers shall be kept continuously “ON” for 24 hrs. The following temperature and relative humidity conditions are maintained in stability Chambers.

• Print out of Temperature and humidity shall be taken for all four channels and Minimum, Maximum and Average value shall be noted for all individual channels.
• Print out of Record of Temperature and Humidity shall be taken on the next day in first half. The person who has taken the printout shall check and put his sign with date on print out. These printouts shall be verified by QA person.
• The excursions in temperature and humidity shall be reviewed.
• In case the stability chamber is not working due to any reason in that case shift the sample in Stand by Stability chamber.

Following criteria’s shall be considered while receiving the spikes in the predefined temperature and RH conditions.

• In case of any eventuality/major break down or maintains of stability chamber which will take more than 24 hrs. Then the samples will be shifted to other chamber i.e. Standby Chamber, which is routed change control.
• In case of power failure, stability chambers shall run on Auto generator.
• If stability chamber cannot be started within 24 hrs, transfer all the samples to other stability chamber set with the same parameters of temperature and humidity and raise a deviation for the same.
• In case of failure of regular humidity and refrigeration system the PLC of chamber will change over to stand by humidity and refrigeration system.
• In case power failure due to government notification for no supply of power for a duration more than 24 hours or in case of any major breakdown for a duration more than a day Stability in-charge shall raise a deviation stating the reason and list comprising details of samples and there age and shall forward it to Head QA.
• Head-QA shall evaluate the lapse time (The duration in number of days during which period the samples under on-going stability study were exposed to ambient condition due to non-functioning of stability chamber). Depending on the lapse time, the Head QA shall recommend extension in stability program for number of days of lapse time plus one day.
• The Stability In-charge shall amend the stability calendar based on the Head-QA recommendation if required.
• The amended stability calendar shall be followed for the remaining age of stability samples charged in the stability chambers affected due to power failure / major breakdown.
• In case of any breakdown in the normal functioning of stability chambers inform maintenance department to rectify immediately. Maintenance department shall contact the manufacturer of stability chamber if problem cannot be rectified by maintenance department.

IV: Calibration:

Calibration Frequency:

• Calibration of Stability Chamber shall be performed by outside agency in a year (± 01 month)

Note: Operation and Calibration of Stability Chambers shall be done as per standard operating procedure.