In the pharmaceutical industry, stability chambers are designed to store the drug product or material in different storage conditions.
Let’s understand What are stability chambers in pharmaceuticals? How stability chambers work? What is the purpose of stability chambers in pharmaceuticals?
What are stability chambers in pharmaceuticals?
For the testing of products and also to determine a product’s shelf life, stability chambers are specifically designed equipment. These can be used to test drug samples, electronic components, industrial materials, etc., where you can adjust the temperatures and humidity to conduct a thorough analysis over varied conditions.
Testing different products require different types of conditions, and moving between different climates is not feasible in most cases. The stability chamber is the answer to the problem and makes the job easier.
Additionally, they are able to assess changes that might affect the product quality when it is exposed to alternating environments.
The purpose of this type of testing is to ensure that no errors are present in the final product and that it operates properly. In case there is any defect in the product that went unnoticed, the stability chambers will identify it and alert us to its existence.
Based on the requirements of the product, this type of testing can take weeks, months, or even years.
There are different types of stability chambers available in the market according to their uses. Those are:
- Temperature and humidity chambers
- Accelerated testing chambers
- Environmental Chambers
- Photostability chambers
The stability chambers in pharma are available in 2 types; 1. Walk-in-chambers and 2. Reach in chambers.
Walk-in stability chambers:
Its name suggests that this type of chamber is larger in size and can be easily walked into. A larger batch of a product, which requires uniform conditions for an extended period of time, can be tested using them.
Reach in chambers:
These types of chambers are small in size and used for small size batches of the product. These chambers are very convenient for usage.
What are stability chamber uses?
Stability chambers are used to measure the performance of the drug product under different conditions such as;
- Dry regions
- High-temperature condition
- Extreme environmental condition
- Exposure to sun
- Rainy condition
- Moisture and humid condition
How do stability chambers in pharma work?
The working principle of a stability chamber is, stability chambers work on the principle that by maintaining a constant temperature, the relative humidity will also remain constant.
Basically, relative humidity is the ratio between how much water the air contains and how much it can potentially hold.
Temperature increases lead to an increase in the amount of water that air can hold, which translates into a decrease in relative humidity. With this method, the relative humidity and the existing temperature co-respond; both are adjusted simultaneously.
Generally, it is essential to follow the ICH guidelines that state that the stability chamber’s temperature should not vary more than 2°C to 3°C and its humidity should not vary more than 5%.
Incorporating both corrosion-resistant stainless steel and proper insulation, the chamber’s body is made of stainless steel on the outside and stainless steel on the inside. The stability chambers in pharma is equipped with shelves where the product can be easily removed.
A temperature and humidity sensor is also attached to the chamber. Temperature and humidity are maintained uniformly within the chamber due to the controlled airflow. It is preferable to have a horizontal laminar flow for better uniformity.
It is possible to ensure a consistent flow of air to the shelves, even when they are fully loaded with samples. The circulation of air is maintained by blowers on the shelves. To receive and transmit information, data loggers are used.
In addition, a glass door is also added which makes it possible for the observer to observe what is taking place inside without disturbing the temperature. There are ports for regularly removing exhaust air.
In Environmental Chambers, also called climatic chambers, different conditions are created for the purpose of testing various products.
With this kind of chamber, any climatic condition can be met, whether dry or humid or rainy or corrosive. There are a wide variety of sizes of tanks and they can be as large as a room, or they can be as small that they are easily accessible from a bench.
When a product has to be assessed for how it will behave under a combination of white light and UV light, photostability testing is required. In this case, safety is a concern as it involves a form of UV light that can be damaging to humans if contacted directly. UV lights should be switched off automatically when chamber doors are opened in order to maximize protection.
Why do pharmaceutical companies use stability chambers?
A stability chamber can be used in a number of ways. The chambers are an integral part of completing a specific manufacturing process. As well as to the automotive industry, cosmetic industry, packaging, studies and research, it is used in many other fields as well.
Research, development, and marketing of pharmaceuticals can prove helpful in medical science. Drug manufacturing becomes quite a priority because they are going to benefit a large number of people around the globe.
People can experience toxic symptoms and side effects when they consume defective drugs. Therefore it is necessary to to drug testing in different conditions.
These are used for testing drugs under different conditions of temperature, humidity, pH, radiation, etc. The products are also used to determine how long the products will be effective. A stability chamber test can also provide evidence regarding the integrity of the product’s packaging.
In addition to identifying errors in the drugs that may make them toxic under certain conditions, they help save time and money by preventing major problems from occurring. The testing can also determine when medication will expire.
Shelf life of a drug is the amount of time a drug will remain effective if it is stored under specified conditions from its date of manufacture. These numbers must be determined through stability chambers and placed on the box to make consumers aware of them.
As Temperature and humidity conditions for stability studies on pharmaceutical samples are defined by the International Commission of Harmonization (ICH) as follows:
Long Term Condition : 25°C +/- 2°C, 60% RH +/- 5% RH
Intermediate Condition : 30°C +/- 2°C, 65% RH +/- 5% RH
Accelerated Condition : 40°C +/- 2°C, 75% RH +/- 5% RH
These chambers can be used to maintain a required temperature uniformity, and they can also be used to store drugs without the need for stable conditions to be achieved in the natural world.
It is essential to maintain and properly check stability chambers in pharmaceutical industry so that drugs can be tested without error.
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