SOP For Operation and Calibration of Humidity Chamber

This document details the procedure for the Operation and Calibration of the Humidity Chamber

It is the policy of Xyz Limited that a written procedure shall be followed for the Operation and Calibration of the Humidity Chamber and its use monitored to ensure smooth operation and its use monitored to obtain consistent and reproducible results minimize downtime and meet regulatory requirements.

This procedure is to be applied at the time of Operation and Calibration of Humidity Chamber.

RESPONSIBILITY 

Persons along with their responsibilities and accountability are given below:

Executive – Corporate Quality Assurance, To prepare the SOP. To maintain the records as per SOP and Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst, To follow the SOP accordingly and To ensure implementation of SOP Manager – Quality Assurance.

 Operation and Calibration of Humidity Chamber

5.1 PRELIMINARY CHECK

5.1.1 Check and ensure that:

5.1.2 The Equipment is clean and free from dust.

5.1.3 There should not be any powder/material inside and the chamber should be free from dust.

Check the availability of water and its label in the boiler tank.

The boiler heater pin should be connected to the boiler heater.

There should not be any clogging between the storage tank and the boiler tank.

5.2 OPERATION PROCEDURE

5.2.1 Switch `ON’ the mains switch on the control panel 

5.2.2 Set the specified temperature (30°C) on the temperature controller of the chamber with the help of the Temperature controller by pressing the up or down keys.    

The bottom SV (Set Value) display shows the set temperature and the top PV (Process Value) display will show the actual temperature.

Set the humidity on the humidity controller of the chamber to 65 % RH with the help of the Humidity controller by pressing the up or down keys.

5.2.5 The bottom SV (Set Value) display shows the set Humidity. And the top PV (Process Value) display will show the actual Humidity

5.2.6 Set the digital safety controller to 30°C. The safety controller cut off the main contactor in case of an overshoot or undershoot of the temperature by 5°C. In case of this type of trip restart the chamber by pressing the pushbutton switch on the control panel.

5.2.7 Allow the chamber to attend the specified temperature

5.3 OPERATION OF PC / PRINTER INTERFACE UNIT:

5.3.1 The PC / Printer interface unit is applicable for the recording of the data of the chamber at a specified period and for connecting the chamber to the PC through the computer software.

5.3.2 To view the specified parameters, press and “SEL” key and view the parameters.

5.3.3 To change the parameters press and hold the “SEL” key till “PASSWORD”  displays.

5.3.4 Select the password by pressing the up key.  Or Down key  

5.3.5. Now select the desired parameter using the “SEL” key and press enter key.

5.3.6 Chang the desired parameter by pressing the up or down key as per the requirement and pressing the enter key to confirm the same.

5.3.7 Again set other parameters like date & time, time interval, printer setting etc. using the same  

5.3.8 Finally select the parameter “LOG OUT” using the “SEL” key and press the enter key to save the selected parameter.

5.3.9 To view the data select the display channel.

Procedure for the Operation and Calibration of Humidity Chamber

5.4 OPERATION OF THE SOFTWARE

5.4.1  Run the Thermolab data acquisition software “enviro” by double-clicking on the icon.

5.4.2 Software will open with a detailed display, which shows the reading received from the chambers.

If NA (Not Applicable) is displayed for any of the Chamber it means the chamber is not connected.

Select the Desired Chamber No. of which the current reading is required to display in current reading windows.

Minimum and Maximum limits can be set by the red colour icon.

To download the data select the green coloured icon to download on position, the data acquired will lead to the system.

5.4.7 To view or to take the printout of the data of a specific period select the date and time and then press Graph or Report.

5.4.8 The graph and or report of the temperature and/or humidity will be displayed according.

5.4.9 Press print to get the printout or select the key to exit in case of the graph and select the “close” key to close the report format

5.5 Maintain the logbook as per Appendix I of  SOP   XYZ/CQA/SOP-016 (Stability of Finished Products)   

6.0 CALIBRATION

6.0.1 Calibration Frequency: Half-yearly

6.0.2 Calibrated Digital hygrometer is used for calibration of the Humidity chamber.

6.0.3 Insert the hygrometer as near as possible to the sensor of the Humidity chamber

6.0.4 Set the temperature first at 30°C & RH 65 %.

6.0.5 When the temperature is stable note down the temperature reading as displayed by Humidity Chamber and reference hygrometer (used for calibration) simultaneously.

6.0.6 Record the temperature and humidity readings at 1 hour, 2 hours, and 3 hours.

6.0.7 Record the calibration data  on XYZ/CQA/SOP-071/FR-01 as Calibration Datasheet Appendix I

6.0.8 After calibration of the instrument, affix the calibration sticker on the instrument and fill in all the required details as per SOP No.XYZ/CQA/SOP-006, Labelling policy.

6.0.9 Report any discrepancy observed during the operation and calibration of the instrument to the Section Incharge or his representative for corrective and preventive action as per SOP No. XYZ/CQA/SOP-030.

6.1 VALIDATION:

6.1.1 Carry out the validation of the chamber to check the temperature distribution at different locations, once in a year or after any major repairs as per respective validation protocol by an external agency or house.

6.1.2 In case of validation fails to meet the desired specifications/criteria, call the service engineer/maintenance personnel. Also, put a label on the equipment indicating its breakdown.  

7.0 GENERATION OF INSTRUMENT CALIBRATION NUMBER    

Generate the instrument calibration number on the calibration datasheet as INSCALXXYYZZZ where INS denotes instrument, CAL denotes calibration, XX denotes the year, YY denotes month and ZZZ denotes sequence number.

8.0 ABBREVIATION

XYZ                  XyzLimited

SOP                 Standard Operating Procedure

QC                   Quality Control

CQA                Corporate Quality Assurance 

>Procedure for the Operation and Calibration of LC/MS/MS


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