Operation, Calibration and Maintenance of Humidity chamber

1.0 OBJECTIVE 

To lay down the procedure for the Operation, Calibration and Maintenance of Humidity  chamber.  

2.0 SCOPE

This SOP is applicable for Operation, Calibration and Maintenance of Humidity chamber. 

3.0 BACKGROUND 

NIL

4.0 RESPONSIBILITY

4.1 QC-Chemist 

4.2 QC-Executive

4.3 QC-Head

5.0 PROCEDURE

5.1. Safety Precautions

5.1.1 Use gloves and goggles while handling equipment (where appropriate).

5.1.2 Don’t switch on the equipment with wet hands.

5.1.3 Don’t open the door while equipment is in operation.

5.1.4 Do not block the air passage area with samples.

5.1.5 Do not place anything on the top of equipment.

5.1.6 Sensor should not be covered with samples.

5.1.7 Air circulation holes at the top and bottom back side of the chamber should not be blocked.

5.2 Cleaning of Equipment

5.2.1 Remove the trays and clean it with the help of cloth soaked in water and soap solution, followed by cleaning with dry cloth.

5.2.2 Clean the walls of the equipment with dry cloth.

5.3 Operating Procedure

5.3.1 Loading of samples:

5.3.1.1 Before loading the samples, ensure all the power switches are in ON position.

5.3.1.2 Ensure adequate water supply to the equipment (Ensure valves are in open condition).

5.3.1.3 Open the door by lifting the handle and turning it in clockwise direction.

5.3.1.4 Load the samples and close the door by turning handle in anti-clockwise direction and pressing down. 

5.3.1.5 After Keeping samples ensure that there are no alarm logs. Enter the details of Loading and unloading of samples in “Usage Log Book of Humidity chamber”(Refer Annexure-1).

NOTE:  Do not open door for more than 5 minutes.                              

5.3.2 ALARMS

Alarms are generated for deviation in temperature, relative humidity, utility failure or system problem. These alarms are generated to attract attention of operators. ALARM SILENCE SWITCH: An audio hooter is activated with the alarm. The alarm message is displayed on the screen. The audible alarm can be silenced by touching ACK button on the screen (HMI) .The alarm silence circuitry will automatically reset  when the out of limit condition returns to normal.

NOTE: Alarm hooter sound can be acknowledged only by trained personnel (or) trained service engineer only after intimation to responsible personnel or department Head.

Following is the list of alarms generated and its description

NOTE: Alarm hooter sound can be acknowledged only by trained personnel (or) trained service engineer only after intimation to responsible personnel or department Head.

ALARM	DESCRIPTION
Door open Alarm	Door of chamber open alarm (more than 5 minutes)
High Temperature Alarm	Temperature of controller or scanner above high temperature limit (more than 10 minutes)
Low Temperature Alarm	Temperature of controller or sensor below low temperature limit (more than 10 minutes)
HT Alarm	High thermostat alarm for cutting of heater ( above 30°C)
LT Alarm	Low thermostat alarm for cutting of cooling system ( below 15 °C)
RH Low Alarm	A low humidity alarm will be generated if the measured humidity remains lower than the set limit for more than 10 minutes.
RH High Alarm	A high humidity alarm will be generated if the measured humidity remains higher than the set limit for more than 10 minutes.

5.3.3 ICDAS SOFTWARE

5.3.3.1 Before starting ensure the configuration of equipment, equipment and PC shall be networked or Ethernet LAN.

5.3.3.2 After switching on the system, software shall open automatically. Click on login button, a login window will open, the user has to login individually with Login Name and Password.

5.3.3.3  Main menu bar shows File, Equipment settings, Analysis Reports, History Report and Help.

5.3.3.4 Click on File it shows Change password and Log out.

5.3.4  Equipment setting

Click on Equipment setting on the menu bar, it displays Equipment master, Equipment status, Header and Footer master. 

5.3.4.1 Click on Equipment Master, it shows the list of equipments which are connected to the software. It consists of different options like Browse Equipment, Equipment Details and Equipment Parameters. In Browse Equipment , select Equipment  Name PE024 (Double click), then it goes to Equipment Details, the window displays   Display Name, IP address, Log Rate, Code , Type, No of Parameters , No of Sensors and On Line status.

5.3.4.1.1 IP Address: Displays unique TCP / IP address for communication.

5.3.4.1.2 Log Rate: This option displays the recording / logging interval for temperature and   Humidity. (minimum 5 minutes).Note: User has to change the log rate, if required.( with the approval of department Head). 

5.3.4.1.3 Equipment parameters

5.3.4.1.4 Click on equipment parameters, this option helps to view the below parameters.

5.3.4.1.5 Set value for Temperature: 

This field allows to create the set valve (25 °C) or appropriate. 

5.3.4.1.6 Lower Limit : User has to assign the lower (alarm) limit (23 °C).

5.3.4.1.7 Upper Limit : User has to assign the upper (alarm) limit (27 °C).

5.3.4.1.8 Set Value for humidity : This field allows to create the set valve ( 60%RH) or appropriate.

5.3.4.1.9 Lower Limit : User has to assign the lower (alarm) limit (55%RH).

5.3.4.1.10 Upper Limit : User has to assign the upper (alarm) limit (65%RH ).NOTE: Accuracy control parameters PID KP, PID TL , PID TD , PID TS ,PID cycle time are factory set. Default value will be shown. Do not modify or change those values. Changing of these values to be done after consulting with technical support team of Newtronic  Equipment Company (P) Ltd.

5.3.4.2 Equipment Status

5.3.4.2.1 Equipment Status option displays equipment is active or inactive. (only admin level user can activate or deactivate the connection of equipment to the software)

5.3.4.3 Header and Footer Details

5.3.4.3.1 Used to create Header and footer for Report formats.                             

5.3.5  Analysis Report

5.3.5.1 Analytical research personnel shall download and verify the data and submit to group leader or  his designee on daily basis. On weekly offs and holiday’s data shall be reviewed on immediate working day.

5.3.5.2 Click on “Analysis Reports” on menu bar and click on” Equipment Data Log”

5.3.5.3 Select Equipment PE024, mention date and time to get the data of Temperature and  Humidity and click on search button.

5.3.5.4 To get a tabular representation, click on report. The report will be generated based on the above data and to print the report, click on “print” button.

Note: In the report, out of limit values will be displayed in Bold.

5.3.5.5 For exporting data in other format, e.g, Acrobat, click on “Export” button, select the  path and type File name to export the displayed data.

5.3.5.6 To get a graphical representation, click on “Graph” icon. Select the option of 2D line graph or 2D bar graph. Three straight lines, one each of set value, upper limit and lower limit shall be displayed on the graph along with the graphical display of actual acquired values.

5.3.6 History Report

This field allows to take history report of Master (Equipment Master, Mobile  Detail Master, User Master, Header Footer Master) Equipment Data Log, Alarm Log and Audit trails (Equipment Audit Trails, Alarm Audit Trials, SMS Transmission Trial, User Audit Trial).

5.3.6.1  Mobile Detail Master

5.3.6.1.1By enabling this option mobile numbers of concern person to whom the software will send alarm SMS in case of out of limit in temperature or humidity. In this form maximum 6 persons can be listed. PLC which will transmit alarms to defined numbers in the event of PC communication failure.

5.3.6.2 User Master

5.3.6.2.1 It Consist of Browser user (consisting of User name, Login name of all personal usingPE024) and User Details (Consisting of User Name, Login Name, Status, Password Change Duration etc.

5.3.6.3 Alarm Log

5.3.6.3.1 Select the Equipment Name ( PE024 ) Date and Time for which alarm log is to  be viewed and click on the search button to get details. To get print click on report option followed by print option. 

5.3.6.4 Equipment audit Trail

5.3.6.4.1 Select the Equipment PE024, User name, Date and Time for which audit trail is to be viewed and click on the search button to get audit trails details. To get print click on report option followed by print option.

5.3.6.5 Alarm Audit Trail

5.3.6.5.1 Select the Equipment PE024, User name, Date and Time for which audit trail is to be viewed and click on the search button to get audit trails details. It consists of  Alarm Ack Date ,Ack Time and comments , to get print click on report option followed  by print option.

5.3.6.6  User audit Trail

5.3.6.6.1 In search filter option, select the User, Date and Time for which the data has to be viewed and click on the search button. It will display the audit Trail details. To get print click on report option followed by print option.

5.3.7  Real Time Display and Real Time Summary

To check the status of the controlled parameters in the chamber in a graphical representation click on Real time display. To check the status of the controlled parameters in the chamber in a tabular form, click on” Real Time Summary”.

5.3.8  Inputs and Outputs

By clicking on “inputs and outputs” button it shall show online status of the Device utilities and the subsystems of the equipment with digital input, digital output and analog inputs to the system.

5.3.9   Alarm Log of the Humidity Chamber

5.3.9.1 During taking print outs of the chamber data, when temperature or humidity of the  chamber found out of the limits, click on  “Alarm log”.

5.3.9.2 In this window the user shall view list of Equipments connected to the software. Select equipment name PE024 , date, time and click on the search icon. User can view the list of alarms and status of the alarm.

5.3.9.3 “Alarm Log” icon is continuously blinking indicating Unacknowledgement of alarms.

5.3.9.4  After reviewing the alarm log analyst shall intimate the group leader or head of department and service engineer for corrective action (if required). Take report of the alarms by clicking  on the “Report” icon and attach to the data report in case of temperature or humidity readings found out of limits and comment on it. Acknowledge the alarms with proper justification.

5.3.9.5 If the temperature or humidity inside the chamber is not uniform, check for the proper functioning of the blower motor fans situated on the backside of the stability chamber.

5.3.10  Alarm Acknowledge

5.3.10.1 To acknowledge the alarm, double click on the status of alarm (Not ACK) .Click on Acknowledge button, the software shall ask for conformation, after clicking “Conformation” enter comments in comment box. Once the alarm is acknowledged it will not be displayed in the alarm log.

5.3.10.2    Whenever, for any equipment alarm is logged, acknowledge the alarm.

5.3.11 Review of print outs

5.3.11.1 Group leader shall review the print outs of humidity chamber including alarm log. He shall prepare a report on the nature as well as duration of deviations , if any and submit the same to Head Analytical Research or his designee for appropriate action.

5.3.12 Investigation of Abnormal Events

5.3.12.1 Incase any outage is recorded, review the same for the duration of the outage due to power failure or is generated by the software.

5.3.12.2 If the total duration of the outages recorded on a single day is more than 4 hours report the same to engineering department through “Reporting, Investigating and Disposing of Incidents and Deviations in Laboratory”.                

5.3.13 Monitoring of Stability chambers

Monitoring of humidity chamber or stability chambers data and alarm log shall be done every day. On  weekly offs and holiday’s data shall be reviewed on immediate working day.

5.4 Enter details of Humidity chamber usage during loading of samples or withdrawing of samples in “Usage Log Book of Humidity Chamber.” (Annexure-1).

5.5 Calibration

5.5.1 Calibrate the humidity chamber for the following parameters, Temperature and Humidity.

5.5.2 Calibration shall be performed by Qualified Personnel (or) External Vendor.

5.5.3 Performance verification of Temperature and Humidity.

5.5.3.1 Distribute temperature & humidity sensors (External) in chamber at eight corners (Refer Annexure-2) (If samples are not loaded, load the chamber with dummy loads, approximately 70% of its capacity) and set the recording interval as 10 min in data logger. Close and lock the door of equipment immediately, allow the equipment to attain the required temperature and humidity (25OC and 60 % RH) , now start recording the temperature and humidity of the equipment for minimum of 24 hours. Enter the details of calibration in “Usage Log Book of Humidity chamber” (Refer Annexure-1).

5.5.3.2 Collect the data at three different time intervals in a day (i.e morning, afternoon and evening ) and record the observations in (Refer Annexure-3).

5.5.3.3 After completion of 24 hours take the print outs of both external data loggers data and chamber sensors data. Group leader or Head of department shall review the data and shall submit the data to service engineer.

5.5.3.4 Frequency: Yearly once or after every major maintenance job.

5.5.3.5 Acceptance criteria: Data loggers temperature and chamber temperature shall not  differ by  25 ± 2 °C. Relative Humidity values of the data loggers or external sensors and the chamber sensors shall not differ by 60 ± 5 %RH. 

5.6  Maintenance

5.6.1 Maintenance shall be performed by Service Engineer (or) External Vendor.

6.0 REFERENCES

6.1 Newtronic humidity chamber instruction manual operation guide.

7.0 VERSION HISTORY

8.0 ANNEXURES