- What are stability Chambers?
- How does it work?
- What is the purpose of stability chambers in the pharmaceutical industry?
- What are the best stability chambers providers / solutions?
What are stability Chambers?
Stability Chambers are specially designed equipment for the testing of products and also to determine their shelf life such as drug, electrical components, industrial materials etc which enables you to tweak parameters like temperature, humidity to conduct a thorough check over varied conditions. Different products need different kinds of conditions for testing but it’s practically not feasible to move around the place for different climate conditions. And that's where stability chambers come to the rescue and makes the job easier. They also manage to assess changes that might cause the product quality in situations of alternating environmental exposure.
This kind of testing forms an integral part of many product making procedures simply because it gives the green signal for no error in the final product and its proper working.
If there’s any defect in the product which went unnoticed then the stability chambers can detect it and bring to our attention. This kind of testing can take upto weeks or even months or years according to the requirement of the product.
There are different kinds of chambers available according to their applications. They are:
- Environmental Chambers
- Temperature-Humidity Chambers
- Accelerated testing chambers
- Photostability Chambers
Stability Chambers are available in two types which are:
Reach in Chambers:
These are the ones usually small in size which are used for testing small batches of products. They are very convenient to use.
Walk in Chambers:
This kind as the name suggests are larger in size and can be walked into to manage it. They are used for the testing of bigger batches of products which require uniform conditions for an extended period of time.
The stability chambers are used to record performance of a product in these given conditions:
- Moisture/humid conditions
- Dry regions
- Rainy conditions
- Exposure to sun
- High temperature conditions
- Extreme environmental changes
How does it work?
The working of a stability chamber is based on a simple principle which is that by maintaining a stable temperature, stable value of relative humidity will also be maintained.
Relative humidity is the ratio of how much water the air has and how much it could potentially hold. With increase in the existing temperature, the amount of water that air can hold increases which leads to the corresponding decrease in the relative humidity. This is how both the parameters are adjusted simultaneously and automatically.
It is very important to adhere to the ICh guidelines which states that the temperature in the stability chamber should not deviate by more than two to three degrees and humidity should deviate no more than 5%.
The outer body and inner body of the chamber is made up of corrosion resistant stainless steel with the inner body lined with proper insulation. A number of shelves are provided inside the chamber for placing the product which can be easily removed. Sensors are also attached for detecting temperature and humidity levels inside the chamber. Due to the controlled air flow inside the chamber uniform conditions of temperature and humidity is maintained. Horizontal laminar airflow is preferred for better uniformity of required conditions. With this kind of a system, even when the shelves are fully loaded with samples, they will receive a consistent flow of air. Proper circulation of sir is maintained through attached blowers. Data loggers are used for receiving and transmitting of data.
A very useful feature is also added that is the glass door which allows the person for the observation of what is happening inside without disturbing the internal temperature conditions. Ports are available for regular removal of exhaust air.
Environmental Chambers also known as climatic chambers are used specifically for creating different ranges of climatic conditions for the testing of certain products. From dry or humid conditions to rainy to corrosive, this kind of chamber can provide any required climatic condition. Their sizes are variable and can be as big as a room or as small that it can be accessed from a bench also.
Photostability testing is required when assessment has to be done about how a product will behave under the combined effect of white light and UV light. This probes safety as a concern as it involves dealing with UV light which is harmful to humans if came in direct contact. Chambers that automatically switch off UV light when the door is opened should be used for added protection.
What is the purpose of stability chambers in the pharmaceutical industry?
The applications of stability chambers are diverse. They are an integral part in completion of manufacturing a specific product. It also has uses in automotive industry, cosmetic industry, packaging, biological or microbiological tests, research work and many more.
Pharmaceutical industry deals with developing, researching and marketing drugs that can prove helpful in the medical science. These drugs are going to cater to a lot of people in different parts of the world and hence ensuring proper manufacturing of drugs becomes quite a priority.
A defective drug developed and consumed by people can lead to side effects and toxic symptoms. Therefore stability testing of drugs in different conditions becomes essential.
Stability Chambers are used for this purpose in this industry. They help for the testing of drugs in varied conditions of temperature, humidity, pH, radiations etc . They are also used to check for how long the product will be efficient to use. Also evidence about the integrity of the packaging of the product is also known from stability chamber testing. The testing draws your attention to error in the drugs that might cause the drug to be toxic in certain environmental conditions and saves a major amount of time and loss to happen. Expiry date of any drug is also determined through this testing.
From the date of manufacture, for how much time the drug will remain effective if stored in specified conditions is called shelf life of a drug. It is mandatory to determine this number through stability chambers and put in on the box for the awareness of a consumer.
As per International Commission of Harmonisation (ICH), the given temperature and humidity conditions for stability studies on pharmaceutical samples are :
Long-term studies: 25°C +/- 2°C, 60 +/- 5%RH
Intermediate studies: 30°C +/ – 2°C, 65% +/- 5% RH
Accelerated stability studies: 40°C +/- 2°C, 75% +/- 5% RH
As these chambers are able to maintain a required stable uniform temperature, they are also leveraged for storing drug samples that require stable conditions that can not be achieved by natural means.
The maintenance and proper checking of chambers should be taken seriously in the pharmaceutical industry so the testing of drugs is error free.
What are the best stability chambers providers / solutions?
Of all the options available today, to use the appropriate stability chambers for industrial use is vital as it decides whether your product is fully ready or not to get in the market and put to commercial use. The chambers put to use should be stable, consistent and reliable. Adding to this, even a slight malfunction can cause break down of the chamber and months of serious efforts can go in vain. So make sure to check the durability of the chamber and its long term performance while choosing the best stability chamber in the market.
The right kind of stability chamber should meet all ICH guidelines and should be operated accordingly.
Also to choose proper software that works behind the chambers is a primary step.
Proper systems and options should be available to address different issues like shelving, doors, documentation, security and many others.
Enviro technologies provide the best solutions for the management and testing of stability chambers given the intensive research and experience they hold. It is a microcontroller based electronic device and also gives you an LED alarm system in case of fluctuations from desired levels of temperature. It does come with a 128*64 alphanumeric graphical display. The software allows you to have audio trail reports, graphs, reports etc related to the testing conducted of a certain product.
Enviro has designed it in a way that it records as well as monitors various important parameters like temperature,humidity, LUX and UV. It adds an advantage to the user as it reduces manual work of recording different results and saves time.
Huge loss will be faced if the data of certain testing is lost or accessed by a person without authority. Hence it is advisable to have data backups at regular intervals for security. Enviro technologies provides a solution for stability chambers that has automatic data back-up feature and also a top notch data management system. The software also comes with a safe and secure login system with password. It’s transaction capacity is upto 4500 with one PID with one parameter.
A lot of manufactures of stability chamber solutions are available in the market but to shortlist the one that serves all purposes and is secure is critical. Enviro Technologies brings you the kind of solution you have been looking for that works with utmost accuracy and consistency.
For more details, features and specifications you should check out https://www.enviro-technologies.com