Humidity Chamber-Stability Chamber Operation and Calibration

1.0   Purpose    : The purpose of this SOP is to lay down the operating procedure for handling of                Humidity Chamber.

2.0 Objective   : To provide a guideline how to operate and calibrate the Humidity Chamber in QC department of ------ Pharmaceutical Ltd.

3.0   Scope        : The Scope of this SOP is to train and qualify the person in Humidity Chamber.     

4.0   Responsibility:

·        Primary: QC Officer

·        Overall: Manager QC

5.0              Procedure:

5.1       Instruments details:

                        Name      :  Humidity Chamber

Make      :  EIE Instruments

Model     :  EIE-106

I. D. No.  : 

5.2         Operation:

5.2.1   Plug the chord of instrument to power supply and switch ON the Main mains toggle switch.

5.2.2 The digital temperature controller display for process value (PV) as ambient temperature.   

5.2.3    Set the desired temperature on Temperature Controller by pressing knob point of the dial.

5.2.4    Set the desired humidity on Humidity Controller by pressing knob point of the dial.

5.2.5    The Set temperature / humidity can be varied to any point within the full range of 10 to 60 ^oC of temperature and 45 to 95 %.

5.2.6   Compressor should be kept continuously ON while setting the temperature below ambient but it should be “OFF” for temperatures above ambient.

5.2.7    Set Time period by using ON /OFF Timer

5.2.8    Open the R.O. Water valve for water filling the reservoir. The Humidity Chamber is ready to use once the desired temperature and Humidity is achieved.

5.2.9    Put “OFF”‘the Humidity Chamber whenever not required for a longer period.

5.3       Calibration Procedure:

5.3.1  .Keep the calibrated thermometer in three different locations Top, Middle, Bottom and note the readings in display of microprocessor. The difference between the Calibrated thermometer and display should be NMT 0.5 ^oC.

5.3.2   Keep the calibrated R.H meter in three different locations Top, Middle, Bottom and note the readings in display of microprocessor. The difference between the Calibrated thermometer and display should be NMT 1.0 RH.

       6.0    Precautions:

6.1              Keep the instrument in clean dust free, air room and in ambient temperature.

6.2              Connect the reservoir tank to the chamber, avoid using hard water for reservoir tank, don’t Use high pressure tap water.

6.3              Don’t open the doors wide for long time period.

6.4               If the instrument does not produce reliable results or if the response is poor, label it as “UNDER MAINTENANCE” & should be repaired or serviced.

6.5               Preventive maintenance is done when ever required.

      Clean the chamber from inside and outside after use.

HUMIDITY CHAMBER CALIBRATION RECORD

                                                                                                                                                       

             Date of Calibration:                                                   Next Calibration due on :

CALIBRATION SUMMARY

1.   Check the Instrument for Cleanliness:                                       

            Observation: Satisfactory/ Not Satisfactory                                                      

                                               

2.   Any other Maintenance:                                                                       

            Observation: Required / Not Required                                                  

Calibration performed using Calibrated Thermometer:

Thermometer used:                                          Code No:

Range:                                                              Date of Calibration:

Set temperature: 40.0^oc and 75% ± 5 .0 RH.

Location	Temperature in Digital Display	Temperature of Calibrated Thermometer	RH Digital Display	RH in Calibrated RH meter.
Top
Middle
Bottom

Remark: The Instrument is calibrated as per the written procedure and Complies/ Does not comply with the acceptance criteria.