A stability chamber works on the principle of maintaining the relative humidity (RH) and temperature of the chamber with the help of thermostats and water reserved in the chamber. As per the law of physics, the air can maintain higher humidity with the help of high temperatures in the chamber because the high temperatures increase the capacity of air to maintain higher humidity in specific conditions, that is the stability chamber working principle
Stability chambers are designed to create artificially replicating conditions for medicines that might be exposed to various environmental conditions. Sometimes it is used to accelerate the effects of exposure to atmospheric conditions that may be adverse in any area where this medicine may be stored.
Users also Read: USFDA inspection checklist for pharmaceutical facility
The product manufactured in the US may not be sustainable in Indian environmental conditions, so it is very necessary to check the stability of the product by testing it, by keeping it in Indian environmental conditions developed in a stability chamber in a US laboratory, It allows the manufacturer to analyze the effects of stability chamber’s conditions on the product in a short span of time by accelerating the conditions.
SOP for the Stability Chamber
Objective
To lay down a procedure for the operation of a stability chamber with total PLC control and touch screen HMI [LABO].
Scope
This procedure is applicable to the Quality Control Department of XYZ Pharma company.
Responsibility
Quality control Officer/Executive.
Quality control Manager.
Accountability
QA Head.
Procedure:-
- Put ON the mains switch on the control panel to start the stability chamber.
- The main screen shows the Set Point and process value of the controlling sensor at the top of the screen.
- AT at the right of the set point window indicates the auto-tuning status for the temperature and humidity.
- REFRIG. SYS indicates which refrigeration system is running.
- HUMID. SYS indicates which humidity system is running.
- CHAMBER indicates chamber status with a countdown timer. For example OFF MODE, RUNNING MODE, and 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 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 alarm is accepted.
- System can be started through PLC, when the start button is pressed, the system shall only start the main contactor. The blower and refrigeration system should start only after 2 minutes. After the starting of the blower and refrigeration system, with a delay of around 30 seconds, Air heater and healthy humidity system shall start with PID action.
SET THE TEMPERATURE ON HMI
1 To set the temperature select the Menu button from the main page, which will navigate to the page shown below.
2 Select TEMP. CONT. a button from the Main Menu Page which will navigate to the page shown below.
3 On this page User can set the parameter for the temperature-controlling sensor and temperature scanners.
4 On this page user can also start the temperature auto-tuning by pressing the button which is given top-right side of the screen
5 After the required setting, press the save button on the HMI to save the setting made.
SET THE HUMIDITY ON HMI
1 Select HUMID. CONT. button from the Main Menu Page which will navigate to the page shown below.
2 On this page user can set the parameters for humidity-controlling sensors and humidity scanners.
3 On this page user can also start the temperature auto-tuning by pressing the button which is given top-right side of the screen.
4 After the required setting is made press the save button on the HMI to save the setting made.
CHECK SCANNER READING
1. A Scanner of 8 channels is provided with built-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.
2. One can view scanner reading by selecting the VIEW button from the main page which will Navigate to the page shown below.
3. TEMP 1 To TEMP 4: Display the current process value of channel 1 to 4 temperature sensors. Value with Red background indicates out of range from the upper limit. Value with Blue background indicates out of range from the Lower limit.
4. HUMI 1 to HUMI 4: Display the current process value of channel 1 to 4 humidity sensors.
5. 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
1. Select the GRAPH VIEW button from the Main Menu page, select the Trends button, then select temperature humidity to view the respective trends
To check the chamber/scanner report from HMI touching the SYSTEM Button on the Main Menu page will navigate to the below page.
PRINT FORMAT
1.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 select the Save button to save the data.
2. On touching the Offline Print button on the Main Menu Page will navigate to the Offline Print page as shown below
3. Select the REPORT Type. Enter START PRINT Date and START PRINT Time from which data printing is required is to enter in DD MM YY format and HH MM format respectively. ENTER PRINT Date & END PRINT Time till which data printing is to enter DD MM YY and HH MM format respectively.
4. Print Interval: Print Interval can be entered from 1 to 999 minutes.
List of annexures and formats.
None
References
SOP on SOPs.
Equipment manual- Thermolab
Safety Precautions
Do not touch the power chord with moist hands.
Summary
In fact, the stability chamber working principle is the same for all industries’ stability chambers, but the SOP for the stability chamber may be different according to the type of product for a particular industry. In this article, we discussed the SOP for the stability chambers used in the pharmaceutical industry. However, in every industry environmental chambers are used to accelerate temperature and relative humidity to check the stability of the product in artificially worse-developed conditions.
Frequently Asked Questions:
How does a stability chamber work?
In the stability chamber, the temperature is increased with the help of thermostats and heaters, then the air present in the chamber maintains the moisture in it. The temperature value is controlled by regulators that result in a constant relative humidity in the chamber.
What is a stability chamber?
A stability chamber is a physics instrument that is widely used in the pharmaceutical manufacturing industry to evaluate the self-life and quality status of products at different levels of atmospheric conditions. Probable adverse conditions are generated inside the chamber to do stability studies of pharma products in an accelerated manner of time.
Related Posts:
- LATEST DPCO LIST 2020
- PRINCIPLE OF AUTOCLAVE
- UV spectrophotometer calibration
- HPLC calibration method
- KARL FISCHER TITRATION AND CALIBRATION
