This document details the procedure for the Operation and Calibration of Humidity Chamber. It is the policy of Xyz Limited that a written procedure shall be followed the Operation and Calibration of Humidity Chamber and its use monitored in order to ensure smooth operation and its use monitored to obtain consistent and reproducible results and to minimize downtime and to meet regulatory requirements.
This
procedure is to be applied at the time of Operation and Calibration of
Humidity Chamber.
RESPONSIBILITY AND Accountability
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.
PROCEDURE
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 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 65 % RH with the help of the Humidity controller by pressing 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 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
PC / Printer interface unit is applicable for the recording of the data of the
chamber at a specified time period of time and to connect
the chamber to 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 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.
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 of time 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 display
according.
5.4.9
Press print to get the printout or select key to exit in case of the graph
and select “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, 2hour, 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 operation and calibration of instrument
to 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 In the 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 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
