Stability chambers maintain controlled temperature and humidity to test product stability, especially in pharmaceuticals.
Chambers typically operate at temperatures from -20°C to 94°C, though common ICH pharmaceutical conditions include 25°C/60% RH and 40°C/75% RH. Humidity levels range from 20% to 95% RH, with options for lower (5%) or higher (98%) via accessories.
Temperature control uses heating, cooling, and fans for uniformity, while humidity relies on steam generators or desiccants. Sensors, data loggers, and alarms ensure precise monitoring and safety.
Guidelines specify long-term (25°C/60% RH), accelerated (40°C/75% RH), and other zones like 30°C/65% RH for shelf-life testing. Deviations should not exceed ±2-3°C or ±5% RH.
There are various types of stability chambers, each designed to fulfil particular testing requirements:
Reach-in Chambers: These chambers offer easy access for rapid testing while preserving regulated conditions, making them perfect for smaller quantities.
Walk-in Chambers: Ideal for larger batches, these chambers provide enough room for in-depth stability tests and are made for longer testing times.
Additionally, there are a number of specialty chambers. Environmental chambers replicate particular climate conditions, usually keeping humidity levels between 60% and 75% and temperatures between 25°C and 30°C. They are therefore crucial for focused testing. In order to expedite stability tests or replicate the aging process, Accelerated Testing Chambers subject products to harsh conditions, often at 40°C and 75% humidity.
Temperature-humidity chambers accurately regulate both temperature and humidity, as their name implies. They usually keep the temperature between 25°C and 30°C and the relative humidity between 60% and 75%. For comprehensive stability assessments of pharmaceutical items, this control is essential. Last but not least, photostability chambers are used to test how items respond to light exposure. They usually replicate circumstances similar to sunlight, with 200 watt hours of UV radiation per square meter and an intensity of about 1.2 million lux over a predetermined period of time. To ensure that items retain their quality in a variety of lighting situations, testing is crucial.
In pharmaceutical applications, stability testing chambers are used for:
