There are lots of different products out there and before they get to market, products need to be tested in all kinds of environmental conditions to make sure that both quality and shelf life are maintained. However, it’s not easy to move products around just to replicate different climate conditions.
This is where stability chambers come in. Specially designed for product testing, stability chambers are vital pieces of equipment that are used to determine the shelf life of products such as drugs, electrical components, industrial materials and more using various parameters like temperature and humidity to conduct thorough checks in variable conditions. They also assist in assessing changes in product quality when in situations of alternating environmental exposure.
Stability testing forms an integral part of the product manufacturing processes, in order to ensure that the final product is working properly, and is of higher quality and longevity. The testing provides valuable data to the manufacturer for improvement of their products, and guidance towards adjusting products that are already on the market. However, stability testing may take weeks, months or even years to complete, according to the product’s requirement.
There are different kinds of stability chambers available according to their applications:
- Environmental Chambers
- Temperature-Humidity Chambers
- Accelerated testing chambers
- Photostability Chambers
These are further available in two types which are:
Reach In Chambers
These are usually small in size and are used for testing small batches of products. They are space-saving, easily movable and very convenient to use.
Walk in Chambers
These are much larger stability chambers that can be walked into and can be purchased as a pre-manufactured unit for instant installation or configured to fit specific requirements. They are used for the testing of larger batches of products which require testing for given conditions over an extended period of time:
- Moisture/humid conditions
- Dry regions
- Rainy conditions
- Exposure to sun
- High temperature conditions
- Extreme environmental changes
Stability Chambers in the Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces and markets drugs that provide valuable medical benefits. These drugs may be used by many patients around the world in order to treat, cure, prevent, or diagnose a disease or to promote well-being. Therefore, ensuring the proper manufacturing of drugs is vital.
Defective drugs that have been developed may cause adverse side effects or toxic symptoms once consumed. This is why stability testing of drugs especially for different conditions is essential.
Stability chambers help in testing drugs in varied conditions for temperature, humidity, PH, radiation and etc. They’re used to determine how long a product will be viable and efficient for use and to provide evidence on the integrity of the product’s packaging.
Such testing would draw attention to errors in drugs that might turn toxic due to certain environmental conditions and prevents the loss of time and life if said drug was taken.
In addition stability testing helps to determine the expiry date of any drug or its effective shelf life, from the date of manufacture to how long it would remain viable based on specific storage conditions. The expiry date must be determined through stability chamber testing and printed on the box for consumer awareness.
According to the International Commission of Harmonisation (ICH), the given temperature and humidity conditions for stability studies on pharmaceutical samples, especially Active Pharmaceutical Ingredients (API) cover:
- Long-term studies: 25°C +/- 2°C, 60 +/- 5%RH, with a minimum of 12 months or 6 months time period (for existing APIs only)
- Intermediate studies: 30°C +/ – 2°C, 65% +/- 5% RH, with a minimum of 6 months time period
- Accelerated stability studies: 40°C +/- 2°C, 75% +/- 5% RH, with a minimum of 6 months time period
Stability chambers may also be used for storing drug samples that require stable conditions and uniform temperatures not achieved by natural means.
The continued maintenance and checking of chambers should be conducted regularly in order to ensure that all drug testing is done error-free.
ETS STABILITY CHAMBERS
Our Stabilty Chambers are designed to keep drugs, cells, plants, tissue, fungal cultures and other samples which require accurate temperature control and consistent uniformity. They incorporate an optimised evaporation and condensation system, with strong cooling and low energy consumption along with standard temperature control and alarm monitoring features.
Contact us for a quote or to answer any questions you may have.