SOP for Operation and Calibration Procedure for Stability Chamber

OBJECTIVE 

To lay down a procedure for the Operation and Calibration of the stability Chamber installed in the Quality Control Laboratory. 

SCOPE 

This procedure is applicable to the stability Chamber (Make-Thermo Lab scientific equipment) installed in the Quality Control Department at XYZ Limited.

RESPONSIBILITY 

Execution: Chemist and above - QC department. 

Checking: Asst. Manager and above - QC department.

PROCEDURE

Operating Procedure 

TO START THE CHAMBER 

• Put ON the mains switch on the control panel. 
• The display of HMI should be as shown below. 

MAIN SCREEN: 

• It shows the Set Point and Process value of the controlling sensor at the top of the screen. 
• AT at the top right of the Setpoint window indicates the Auto Tuning Status for Temperature and Humidity. 
• REFRIG. SYS Indicates which refrigeration system is running. 
• HUMID. SYS Indicates which humidity system is running. 
• CHAMBER Indicates chamber status with countdown time.  e.g. OFF MODE, RUNNING MODE, STABILIZATION, etc. 
• TEMP. SENSOR Indicates which temperature sensor is in control MAIN OR STANDBY. 
• HUMID. SENSOR Indicates which humidity sensor is in control MAIN OR STANDBY. 
• Just below the sensor status strip shows the active alarm status. If the strip is red it indicates the alarm is active. If the strip is yellow it indicates the alarm is accepted. 

Switch ON the chamber through PLC

• When the Start button is pressed to start the chamber, the system should only start the main contractor. The blower and Refrigeration system should start only after 2 mins. After starting of blower and Refrigeration system, with a delay of around 30 seconds, Air heater and healthy humidity system should start with the PID action (soft start). 

ALSO READ: SOP for Difference between Stability and Release Specification

STARTING THE CHAMBER WITH REGULAR SYSTEMS:

• If the START button on HMI is pressed to start the main contactor, only if the water level is present with the door is closed, the safety thermostat temperature contact is closed & the safety thermostat in the humidity tank is closed and the mains power supply is present, at least one sensor of both temperature & humidity should not be open (i.e. it should be closed) then PLC will switch ON the mains contactor after 5 sec. 

Set the temperature on HMI 

• To set the temperature select the Menu button from the main page, which will navigate to the page shown below. 

• Select TEMP. CONT. a button from the Main Menu Page which will navigate to the page shown below 

• THE TEMPERATURE SETTINGS page allows doing the following settings in temperature. In this page, user can set the parameters for temperature controlling sensors and temperature scanners. In this page, user can also start the temperature auto-tuning by pressing the button which is given top-right side of the screen. After the required settings are made press the save button on the HMI to save the settings made. 
• Select HUMID. CONT. a button from the Main Menu Page which will navigate to the page shown below 

• The HUMIDITY SETTINGS page allows doing the following settings in humidity. In this page, users can set the parameters for humidity-controlling sensors and humidity scanners. On this page, the user can also start the temperature auto-tuning by pressing the button which is given top-right side of the screen. After the required settings are made press the save button on the HMI to save the settings made. 

Check Scanner Reading

• A scanner of 8 channels is provided inbuilt in PLC with 4 sensors for temperature mapping & 4 sensors for humidity kept at different locations with printer and PC interface facility available through HMI. One can download the scanned data on the Stability Control System software and the same can be printed on a dot matrix printer. 
• One can view scanner readings by selecting the VIEW button from the Main Page which will Navigate to the page shown below. 

ALSO READ: SOP for Hold Time Study in Pharmaceuticals

• TEMP 1 to TEMP 4: Displays the current process value of channel 1 to 4 temperature sensors. Value with Red background indicates out of range from upper limit. Value with Blue background indicates out of range from the Lower limit. 
• HUMI 1 to HUMI 4: Displays the current process value of channel 1 to 4 humidity sensors. Value with Red background indicates out of range from upper limit. Value with Blue background indicates out of range from the Lower limit.

Check Graph : 

• Select the GRAPH VIEW button from the Main Menu Page, select the Trends button, and then select temperature or humidity to view the respective trends. 

Check Chamber / Scanner Report from HMI: 

• On touching the SYSTEM Button on Main Menu page will navigate to the below page. 

• Print Format: On touching the Report Header Setting button will navigate to the format page, where the Following details are to be entered such as Equipment Name, Equipment ID, Department Name, Company Name & Header Name and then select Save button to save the data. 

• On touching the Offline Print button on Main Menu Page will navigate to the Offline Print page as shown below  

• Select the REPORT Type. Enter START PRINT Date & START PRINT Time from which data printing is required is to be entered in DD MM YY format and HH MM format respectively. Enter END PRINT Date & END PRINT Time till which data printing is required to enter DD MM YY and HH MM format respectively. 
• Print Interval: Print Interval can be entered from 1 to 999 minutes.(60 minutes for daily printout) 
• Print Report: Temperature and humidity records for the stability chamber shall be maintained by taking printouts on a daily basis. 

Set Safety Thermostat 

• The safety thermostat with the range of 0°C to 120°C is provided in the control panel. The Safety Thermostat is provided as an extra safety to safeguard the inside test samples from exposure to high temperatures. It is a safety precaution because it cuts off the Mains Contactor through PLC with text indication on HMI and alarm if the set temperature overshoots by accident.

Set Humidity Safety Thermostat 

• The safety thermostat with the range of 0°C to 150°C is provided in an evaporative tray. Set the safety thermostat at 110°C temperature. On humidity safety thermostat cut off, the PLC should trip the chamber with alarm & indication ON. 

1. Switch on the power. 
2. Switch on the instrument. 
3. After switching on, the drum would initialize itself to the loading position, the logo screen will flash for 3 seconds and the login screen will be displayed. Enter the username and password. 
4. The system is now ready for setting the test parameter and running the test. 
5. Press the start key to run the test. 
6. The drum will start rotating and will stop automatically after four minutes or after completing 100 Counts or whatever the setting has done. 
7. Take out the tablets from the collection tray, de-dust them & then weigh the tablets. 
8. Calculate the % loss as shown below:  

    9. Switch ‘OFF’ the mains. 

SOFTWARE OPERATION 

USER LOGIN PAGE 

• After the software installation is complete execute the Stability Control System icon on the desktop of your system, and the Main Login Page will appear on the PC screen. Enter the valid Login ID ("admin" for the first time) in the space in front of the text User Name. Enter the valid password ("admin" for the first time) in front of the text Password. 
• It takes 10 to 15 seconds for the current status page to display on the screen. If the user name/password is not correct then the software shows an error message in red text. 

REGISTER APPLICATION PAGE 

• After getting logged in to the current status page single click on the Help option. After a single click on the Help option, the Navigation window drags out on the extreme left of the Software screen. The Navigation window shows two options User Manual and About Us. The About Us option has sub-options such as Register Application and Change Password which can be viewed with a single click on the drop-down arrow (in black color) in front of the text About Us. Now single-click on the text Register Application. The Register Application page opens on the right-hand side of the Navigation window. 
• Single-click on the Edit button and enter the Serial number of the Dongle (which is written on the USB Dongle). After entering the Serial number of the Dongle single click on the Save button. The Software will give a popup message of "Serial number saved successfully". Click OK to remove the popup message. During the Registration of the Serial Number if the user by mistake enters the wrong Dongle number then the same can be canceled by a single click on the Cancel button. 
• Once the Dongle registration number is saved log in from the software go to START RUN type is reset and press the enter key. The command prompt will appear and disappear after some time. 

USER MASTER PAGE 

• After the registration process is complete single click on the Admin option of the software. When the user clicks on the Admin option the Navigation window on the extreme left of the screen shows two options Main Options & Security. 
• Single click on the option Security. As soon as the user clicks the option Security three sub-options appear in the drop-down of the security Auto Backup Setting, User Master, and Rights Assignment. Single-click on the option User Master to create a new user or to search the details of the existing user. 
• When the User Master text is single clicked then the User Master window appears on the right-hand side of the Navigation window. The user can search the details of the existing user by typing the Login ID of the user and single-clicking on the microscope symbol in the field of the Login ID. If the user does not exist or if the validity of the user is expired then the Search Dialog popup appears which indicates that the record does not exist in the system. With the help of the Edit option on the toolbar of the User Master window the user can edit the details of the existing user. 
• The password cannot be edited in the User Master window since a separate window is provided to change the password. To create the new user single click on the New option on the toolbar of the User Master window. All the mandatory fields of the User Detail section of the User Master window in red indication have to be filled by the user to create a new user.

ALSO READ: System Maintenance Procedure for Walk in Type Stability Chamber

• After filling in all the fields of the User Detail section of the User Master window click on the green color plus sign indication in the User Role Relation section of the User Master window to assign a role (Admin, Master, or General) to the user. As soon as the plus sign in green colour in the User Role Relation is clicked the Role Detail section appears. The user has to manually type the role in the Role Name field. 
• As soon as the Role Name says ADMIN is typed the role automatically appears in the drop-down as ADMIN and below ADMIN is written as ADMINISTRATOR. A single click on the text ADMIN, ADMINISTRATOR, and the Role Name and Description fields will be assigned in the Role Relation section automatically. Once the role name is entered click on the save button in the menu bar of the User Master window. The message will be displayed as Record saved successfully.

ADMIN PAGE (CHAMBER CREATION) 

• After the registration process is complete single click on the "Admin" option of the software. When the user clicks on the Admin option the Navigation window on the extreme left of the screen shows two options Main Options & Security. 
• The main Options drop-down contains the sub-options Chambers and Assign Cambers. Single click on the text Chambers to view the chamber details of one chamber which is by default present in the Chambers window. The user has to click on the row where the chamber is created; a light blue color appears on the row which indicates that the entire row is selected and then click on the Edit option on the toolbar of the chamber window to edit the details of the Chamber. 
• As soon as the Edit option is clicked from the toolbar the Equipment ID, IP Address, and Equipment Name options of the Chamber List (at the bottom of the same window) get activated. Fill in the information as per the chamber and single-click on the Get Configuration button. After clicking the Get Configuration button the text in the Chamber List section appears in red color as Connecting to the chamber along with the IP address. For example, if the user enters the IP address of the Chamber in Chamber List as 192.168.1.119 then after clicking on the Get Configuration button on the left of the Chamber List the text appears in red color appears as Connecting to chamber 192.168.1.119. 
• Within a few seconds, all the information is acquired automatically by the software. The red color text disappears after acquiring the configuration from the chamber. Log out from the software and close the application. Then go to START --> RUN type iisreset and press ENTER. The command prompt appears for a few seconds and then disappears. If the user wants to create a new chamber then click on the Add New option on the toolbar of the window of the chamber. As soon as the user clicks on the Add New option on the toolbar of the chambers window the blank options on the Chamber List section at the bottom appear. The fields of the Chamber List which has to be filled by the user are Equipment ID, IP Address & Equipment Name. After filling these fields click on the Get Configuration button.

• The Get Configuration obtains the information from the chamber automatically. This information includes No. of Channels (4, 6, 8¼etc), Chamber Type (Stability, BOD¼etc), Door Enable (Which is the status of Door Access system; ON or OFF), SMS Enable (Which is the status of GSM system; ON or OFF), and Refrig. System Enable (which is the status of the Refrigeration System in the Chamber; ON or OFF). Click on the Save option on the toolbar of the window of the chamber. A green color text appears on the top right-hand side of the window of the chamber as Records saved successfully. 
• Once the chamber is successfully created in the software, log in from the software, close the application go to START-->RUN type iisreset and press ENTER. The command prompt appears for a few seconds and disappears automatically. Is Active Chamber checkbox is used to disable the chamber that is not in use. (The user must note that it is mandatory to reset IIS once after successfully creating the chamber). 

ADMIN PAGE (ASSIGN CHAMBERS) 

• After the successful creation of the user and chamber in the software, the user has to assign the chamber access rights to the newly created user. Single-click on the option Admin in the software. The navigation window on the extreme left of the screen shows two options Main Options & Security. 
• The main Options drop-down contains the sub-options Chambers and Assign Cambers. Single click on the text Assign Chambers. Assign Chambers window appears on the right-hand side of the Navigation window. To assign the chamber access rights select the user in the Users field with the help of the drop-down arrow in the Users field. After selecting the particular user single click on the Show button present in the Assign Chambers window. 
• The window shows the total number of chambers present in the software with columns Chambers and Allow. The Allow column contains the check box. First, click on any one chamber in the Chambers section. The complete horizontal line will be selected in a light blue color. Now double click on the checkbox to activate the checkbox. Now single-click on the checkbox to allow the access of that chamber to the selected user. 
• A tick mark will appear in the checkbox. Now click on the Save button at the bottom of the Assign Chambers window. A popup message will appear as Record Saved Successfully. Click on the OK of the popup to remove the popup 

CURRENT STATUS PAGE 

• After performing the above 5 steps log out from the software and again log in. The Current Status page will be visible to the user. The current status page shows the set point (SP) and the process value (PV) of Temperature and Humidity respectively. 
• The process Value section indicates the current process values of all 8 channels of Temperature and Humidity respectively. The Status Details section indicates: 

1. The current Refrigeration System is ON (Regular or standby). 
2. The current Humidity System is ON (Regular or standby). This section will not be visible for the Cooling Cabinet, BOD, and Deep Freezer. 
3. Temperature sensor in use (Main or Standby). 
4. Humidity sensor in use (Main or Standby). This section will not be visible for the Cooling Cabinet, BOD, and Deep Freezer. 
5. The mode of the Chamber (Starting, Running, or OFF mode) 
6. The Last Refresh shows the latest refresh the software has performed. 
7. The START button can be used to start the chamber. The user can STOP the chamber by entering the correct password. 

• The active Alarms section shows all the alarms generated in the chamber. A mute button can be used to mute the alarm. This button is activated when the audio alarm is present in the chamber. The accept button can be used to acknowledge the active alarms. 
• Start the chamber by pressing the START button on the current status page of the software. The chamber should get started and all the status of the. If the user wants to stop the chamber then press the STOP button on the current status page of the software. The software will ask for the password to stop the chamber. 
• Enter the valid password of the user who has logged in to STOP the chamber and press OK. The Active Alarm section will indicate the active alarms of the HMI. Generate the fault in the chamber (E.g. Make the Regular water level low. The Active Alarm section must show the Alarm in red colour along with the date and time. As soon as the alarm is generated the Mute & Accept button of the Current Status page gets activated. 
• Single click on the Mute button to mute the audio alarm of the chamber, after the audio alarm of the chamber gets Mute the Mute button of the Current Status page is deactivated. Single click on the Accept button to acknowledge the active alarms in the Active Alarms section. If the fault is rectified then the error gets removed automatically after pressing the Accept button. But if the error is not rectified and the Accept button is pressed then it remains in the Active Alarms section in yellow color. 
• The user must note that if after pressing the Accept button all the active alarms in the Active Alarms section will be acknowledged.

Note:

The alarms remain in the Active Alarms Section in RED color unless it is acknowledged by the user. 

Once the alarms are acknowledged by the user it remains in the Active Alarms section in YELLOW colour unless it is rectified. 

Once the error is rectified it gets removed from the Active Alarms screen. 

The RED color text shows "Dongle is connected" valid dongle is connected to the software. The RED Colour text turns to "Dongle is disconnected" as soon as the dongle is removed. 

(Note: The user must note not to work with the software unless and until the text "Dongle is disconnected" gets converted to "Dongle is connected"). 

CALIBRATION PROCEDURE 

Frequency: Yearly 

Note: Calibration of the instrument is to be carried out by third-party 

ABBREVIATION(s) 

SOP: Standard Operating Procedure 

Q.C: Quality control 

REVISION HISTORY

Nil

ALSO READ: SOP for Forced Degradation Study