Stability chambers in pharmaceuticals are used for a steady, temperature-controlled environment for testing for continuing stability, R&D, and clinical studies of pharmaceutical drugs. They provide actual monitoring, real-time reporting, and an intuitive user interface. Stability chambers are designed based on the specific temperature and relative humidity. The stability study of the product for the entire shelf life is required at the worst temp and relative humidity. These worst conditions are maintained by these chambers. On basis of this stability study, OEMs decide the life of the pharma product. Worldwide ich guidelines for stability chambers are being followed. 
The Testing for chemical, biological, and microbiological processes is possible in a stability chamber. Products can be examined within the chamber to see whether environmental elements like humidity, light, and temperature have an impact on them while they are being stored. Companies can determine how long a product can be stored under specific conditions as well as the drug’s shelf-life by testing the factors that cause changes in the quality of the drug.
Pharmaceutical firms can assess how environmental changes affect a product’s quality with careful observation in testing chambers. Pharmaceutical, life science, medical, biomedical, and other storage, research, and other uses are all well suited for stability test chambers.
Different types of Stability chambers in the markets
• Environmental Chamber.
• Temperature-Humidity Chamber.
• Accelerated test chamber.
• Photostability Chamber.
Stability Zones as per ICH :
International Council for Harmonisation ICH guidelines divide the entire world into 4 different Zones as below:
| Stability Zones | Climatic Condition |
| Zone 1 | Temperate Zone |
| Zone 2 | Mediterranean /Sub-tropical Zone |
| Zone 3 | Hot Dry Zone |
| Zone 4 A | Hot Humid Tropical Zone |
| Zone 4 B | Hot/Higher Humidity |
As a result of differences in temperature and humidity across the globe, there exist numerous climatic zones. According to the Stability zone, ICH has specified certain stability conditions for investigations. The following is a description of the drug product stability research conditions:
Long-Term Stability Testing Conditions
| Stability Zone | Temperature | Humidity | Minimum Duration |
| Zone I | 21°C ± 2°C | 45 %RH ± 5 % RH | 12 Months |
| Zone II | 25°C ± 2°C | 60 %RH ± 5 % RH | 12 Months |
| Zone III | 30°C ± 2°C | 35 %RH ± 5 % RH | 12 Months |
| Zone IV A | 30°C ± 2°C | 65 %RH ± 5 % RH | 12 Months |
| Zone IV B | 30°C ± 2°C | 75 %RH ± 5 % RH | 12 Months |
Working Principle of Stability Chamber:
Stability chambers are operated under a closed premise with maintaining a very steady temperature, and a very stable relative humidity with very less tolerance. The ratio of the amount of water in the air to the amount it can hold is known as relative humidity. With the increase in the existing temperature, the amount of water that air can contain increases which leads to the equivalent drop in the relative humidity. This is how the parameters are automatically and simultaneously modified.
It is crucial to follow the ICh criteria, which indicate that the humidity in the stability chamber shouldn’t vary by more than 5% and that the temperature shouldn’t vary by more than two to three degrees.
The chamber’s inner body is lined with appropriate insulation, and both the outer and inner bodies are constructed of corrosion-resistant stainless steel. Inside the chamber, a number of shelves are available for storing products that can be removed with ease. Moreover, sensors that measure temperature and humidity inside the chamber are installed. Owing to the controlled airflow inside the chamber, consistent humidity, and temperature levels are kept.
This entire setup and the perforated shelves have a study flow of air with controlled temperature and RH used to stock the drug stability samples. . In-line Blowers are used for penetrated air flow & air recirculation. Data loggers with transmitters use for actual monitoring of the temp. and RH at multiple locations.
Adding a glass door, which allows one to observe what is going on inside without upsetting the temperature conditions within, is another highly beneficial feature.
Climate chambers are used to simulate a variety of environmental conditions for the testing of some specific drugs. These more sensitive drugs are kept in a type of chamber that maintain these environmental conditions, whether dry or humid, rainy or corrosive. Their dimensions can range from being as large as a room to be so small that they can also be reached from a bench.
Testing for photostability is necessary when determining how a product will behave when exposed to both white light and UV radiation. This raises questions about safety because it deals with UV radiation, which is dangerous to people if it comes into close contact. To provide further protection, employ chambers that turn off UV light when the door is opened. All testing will be done as per the SOP of Best Laboratories practices.
Major Components of the Stability Chambers:
Equipment | Programmable logic controller (PLC) based Walk – In Stability Test Chamber |
Air Circulation | Motor and blower arrangement to have uniformity of Temperature and RH under loaded conditions. |
Construction | 60mm thick Puf Insulated Panels Both sides 0.5mm thick Stainless steel with cam lock arrangement |
Trays | Stainless steel 304 rack & Trays. |
Insulation | 60mm Thick CFC-free PUF Insulation. |
Lighting | Interior illumination for working area. Fluorescent light |
Heating System | U-shaped S.S. Nichrome wire air heaters. |
Refrigeration System | Hermetically Sealed CFC Free Emerson Compressor with R 134a/R404 refrigerant has state of art bypass system for a continuous run of the compressor. |
Stand by System | Cooling and Humidifier stand by the system. |
Humidity System | Non-condensing type steam injection system with low water level sensor arrangement with insulation to save heat energy. |
Auto change over system | Provide auto change over the system through the PLC program in case of failure of the regular humidity system. |
Control System | Programmable logic controller (PLC): 8-point temperature + 8-point humidity data logging system with sensor placed at specific points in the chamber. |
Calendar for cooling system | Calendar program for the cooling system to operate as settable time (i.e. 3.5 days regular system and 3.5 days standby system) |
Program / Menu | Provide system setting like Temperature control, humidity control, system reset, graph view, user view, SMS election off print line etc. |
Auto start | In case of power fails and resumes system starts automatically with the default set parameter |
HMI / Display | HMI (Touch Screen) |
Validation Port | 40 mm validation Port |
Software | 21 CFR Software Part 11 compliance |
Data storage | The data storage facility in HMI & PC to chamber readings (Temperature and humidity) with the print facility, data transfer facility, and Settable interval time in a minute through Ethernet & LAN connectivity. |
Connectivity | Ethernet, WiFi & LAN connectivity |
Operating software | Provide operating software |
Door Access system | Password-protected door access system |
Remote Alarm System | Chamber has a remote alarm system |
Mobile Alert System | The equipment has an SMS Alert system. |
Power | Works on 440V AC single phase 50Hz. |
Other | Having MCB, with Heavy duty latch integrated with lock & key. |
Safety Features of Stability Chamber in pharma:
| The main safety feature is following which are necessary for stability chambers: | |
1. | The float switch to cut off the Heater supply in case of low water level in the reservoir tank with a low water level alarm system. |
2. | Additional safety thermostat to cut off the boiler system in case of overshoot of temperature. |
3. | Safety control system for overshoot and undershoot temperature and humidity system with audio/ visual alarm. |
4. | Will have 180 Sec. compressor ‘ON’ /OFF post delay timer which is a protection to the compressor. Electrical overload cutoff relay for the compressor. |
5. | Provided Safety bell inside the chamber and bell located at the center place for emergency purposes. |
6. | The emergency door opens from the inside when it’s locked inside. |
7. | Electrical Circuit Breaker, MCB, ELCB. |
Critical parameters of Stability Chambers in pharmaceuticals
Stability chambers, also known as stability testing chambers or environmental chambers, are specialized equipment used in the pharmaceutical industry to conduct stability studies on drugs, vaccines, and other pharmaceutical products. These chambers provide controlled conditions for testing the stability, shelf-life, and quality of pharmaceutical products under different environmental conditions. Some of the critical parameters of stability chambers in pharmaceuticals include:
Temperature: Temperature is a critical parameter in stability chambers as it directly affects the chemical, physical, and microbiological stability of pharmaceutical products. Stability chambers typically have a wide temperature range, typically from -20°C to 70°C or even higher, to simulate various storage conditions that the products may encounter during their shelf-life.
Humidity: Humidity is another critical parameter in stability chambers, as it can influence the stability of pharmaceutical products. Humidity conditions in stability chambers can range from dry conditions (e.g., 0% relative humidity) to highly humid conditions (e.g., 90% relative humidity) to simulate different storage environments.
Light: Light exposure can also impact the stability of pharmaceutical products, especially those that are light-sensitive. Stability chambers may have options for controlling light exposure, such as providing complete darkness or controlled levels of light, including fluorescent or ultraviolet (UV) light, depending on the requirements of the stability study.
Air Flow: Air flow is important in stability chambers to ensure proper distribution of temperature and humidity throughout the chamber. Uniform airflow helps maintain consistent conditions within the chamber and prevents localized temperature or humidity variations that can affect the stability of study results.
Chamber Size: The size of the stability chamber is another critical parameter to consider, as it determines the capacity and flexibility of the chamber for conducting stability studies on different product quantities or sizes. Stability chambers come in various sizes, ranging from small bench-top units to large walk-in chambers, depending on the requirements of the stability study.
Calibration and Validation: Calibration and validation of stability chambers are crucial parameters to ensure accurate and reliable results. Regular calibration and validation of temperature, humidity, and other relevant parameters of the stability chamber are necessary to maintain the integrity of the stability study data and comply with regulatory requirements.
Monitoring and Data Logging: Stability chambers should have a robust monitoring and data logging system to continuously monitor and record the temperature, humidity, and other critical parameters during the stability study. This allows for real-time monitoring and data analysis, and helps ensure that the stability study is conducted as per the predetermined conditions.
Alarm System: Stability chambers should be equipped with an alarm system that can alert operators in case of any deviations from the predetermined temperature, humidity, or other critical parameters. This ensures timely intervention in case of any out-of-specification conditions, helping to maintain the integrity of the stability study.
Security: Stability chambers should have appropriate security measures in place to prevent unauthorized access and tampering with the stability study conditions or data. This includes physical security features such as access controls, as well as digital security measures such as user authentication, audit trails, and data encryption.
Compliance with Regulatory Requirements: Stability chambers used in the pharmaceutical industry should comply with relevant regulatory requirements, such as those set by regulatory agencies like the FDA, ICH, and WHO. Compliance with these regulations ensures that the stability studies are conducted in accordance with accepted industry standards and guidelines.
It is essential to carefully monitor and control these critical parameters in stability chambers to ensure accurate and reliable stability study results, which are crucial for determining the shelf-life, quality, and safety of pharmaceutical products. Proper validation, calibration, and monitoring of stability chambers are essential for maintaining regulatory compliance and ensuring the integrity of stability study data.
Stability Chamber Manufacturers (OEM):
There are many manufacturers of the water system In India, some of the best and legacy OEMs are:
- Newtronics
- Labindia Instruments
- Thermolab Scientific
- HMG India
- Osworld Scientific Equipments Pvt. Ltd.
FAQ Regarding Stability Chamber:
What is a stability chamber in the pharmaceutical industry?
Answer: A stability chamber is a specialized equipment used to conduct stability studies on drugs, vaccines, and other pharmaceutical products to determine their shelf-life, quality, and safety.
Why are stability studies important in pharmaceuticals?
Answer: Stability studies provide data on the changes in the quality and characteristics of pharmaceutical products under various storage conditions, helping to determine their shelf-life and storage recommendations.
What are the critical parameters monitored in stability chambers?
Answer: The critical parameters monitored in stability chambers include temperature, humidity, light exposure, airflow, and other relevant parameters, depending on the specific requirements of the stability study.
What temperature range is typically maintained in stability chambers?
Answer: Stability chambers typically maintain a temperature range from -20°C to 70°C or higher, depending on the stability study requirements.
Why is humidity control important in stability chambers?
Answer: Humidity control is important in stability chambers as it can impact the stability of pharmaceutical products, especially those that are sensitive to moisture.
What is the purpose of light exposure control in stability chambers?
Answer: Light exposure control in stability chambers is necessary for studying the effects of light on pharmaceutical products, particularly those that are light-sensitive.
Why is air flow important in stability chambers?
Answer: Air flow helps in maintaining consistent temperature and humidity distribution within the stability chamber, ensuring uniform conditions for the stability study.
What is the significance of chamber size in stability chambers?
Answer: Chamber size is important as it determines the capacity and flexibility of the stability chamber for conducting stability studies on different product quantities or sizes.
What is calibration and validation in stability chambers?
Answer: Calibration and validation are processes to ensure that stability chambers are accurately measuring and maintaining the desired temperature, humidity, and other parameters, in compliance with regulatory requirements.
Why is monitoring and data logging important in stability chambers?
Answer: Monitoring and data logging allow for real-time tracking and recording of stability study parameters, ensuring accurate and reliable data for analysis and compliance purposes.
What is the purpose of the alarm system in stability chambers?
Answer: The alarm system in stability chambers alerts operators in case of any deviations from the predetermined parameters, allowing for timely intervention and preventing potential issues.
How often should stability chambers be calibrated and validated?
Answer: Stability chambers should be calibrated and validated as per the manufacturer’s recommendations and regulatory requirements, typically at regular intervals and after any significant changes or repairs.
What are the different types of stability chambers?
Answer: Different types of stability chambers include reach-in chambers, walk-in chambers, temperature-only chambers, humidity-only chambers, and combined temperature and humidity chambers, among others.
What is the purpose of compliance with regulatory requirements in stability chambers?
Answer: Compliance with regulatory requirements, such as those set by the FDA, ICH, and WHO, ensures that stability studies are conducted in accordance with accepted industry standards and guidelines.
How should stability chamber data be documented?
Answer: Stability chamber data should be properly documented, including the details of the study parameters, calibration and validation records, and any deviations or corrective actions taken.
What are the best practices for operating stability chambers?
Answer: Best practices for operating stability chambers include regular calibration and validation, monitoring and data logging, proper handling of samples, and adherence to standard operating procedures (SOPs).
How should stability chambers be cleaned and maintained?
Answer: Stability chambers should be regularly cleaned, maintained, and inspected for any potential issues or malfunctions, as per the manufacturer’s recommendations and SOPs.
How many types of stability chambers are there?
Answer: There are different types of stability chambers, including reach-in chambers, walk-in chambers, temperature-only chambers, humidity-only chambers, and combined temperature and humidity chambers, among others.
What is the guideline for stability chamber?
Answer: The guidelines for stability chambers are provided by regulatory agencies such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO). These guidelines provide recommendations on the design, operation, and monitoring of stability chambers for conducting stability studies.
What are stability chambers?
Answer: Stability chambers are specialized equipment used in the pharmaceutical industry to conduct stability studies on drugs, vaccines, and other pharmaceutical products to determine their shelf-life, quality, and safety.
How does it Stability chambers work?
Answer: Stability chambers work by maintaining controlled conditions of temperature, humidity, light exposure, and air flow, as per the requirements of the stability study. Pharmaceutical products are stored in stability chambers for specific time periods, and samples are periodically tested to evaluate their stability and quality over time.
What is the purpose of stability chambers in the pharmaceutical industry?
Answer: The purpose of stability chambers in the pharmaceutical industry is to conduct stability studies to determine the shelf-life, quality, and safety of pharmaceutical products under different storage conditions, helping to ensure their efficacy and safety for use by patients.
What are the best stability chambers providers/solutions?
Answer: There are several reputable providers/solutions for stability chambers in the market, and the choice of the best one would depend on specific requirements, budget, and other factors. Some popular stability chamber providers/solutions include Thermo Fisher Scientific, Binder, Memmert, Esco, and Angelantoni, among others.
What is the use of stability chambers in the pharmaceutical industry?
Answer: Stability chambers are used in the pharmaceutical industry to conduct stability studies, which are an essential part of the drug development process, to determine the shelf-life, quality, and safety of pharmaceutical products and comply with regulatory requirements.
What is the difference between a stability chamber and a humidity chamber?
Answer: A stability chamber is designed to maintain controlled conditions of temperature, humidity, light exposure, and air flow, while a humidity chamber is specifically designed to maintain controlled conditions of humidity only. Stability chambers are more comprehensive and versatile, whereas humidity chambers focus solely on humidity control.
What is the temperature of a stability chamber?
Answer: The temperature of a stability chamber can vary depending on the specific requirements of the stability study, but typically, stability chambers maintain a temperature range of -20°C to 70°C or higher.
What are the four climate zones for stability study?
Answer: The four climate zones for stability studies, as per the ICH guideline, are Zone I (25°C/60% RH), Zone II (30°C/65% RH), Zone III (30°C/75% RH), and Zone IV (40°C/75% RH).
How many zones are there in a stability study?
Answer: There are four zones in a stability study as per the ICH guideline, namely Zone I, Zone II, Zone III, and Zone IV, each with specific temperature and humidity conditions.
What is Zone 4 stability?
Answer: Zone 4 stability refers to the climatic condition of 40°C/75% relative humidity (RH) as per the ICH guideline, which is one of the four climatic conditions used in stability studies to evaluate the stability of pharmaceutical products under accelerated storage conditions.
In India, many vendors have the setup for Stability Chambers if you want to know more about the system. Please feel free to contact: admin@flairpharma.com
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