Stability test chambers are designed to conduct stability and shelf life studies on different products.
What are Stability Chambers used for?
Stability test chambers are measure the effects of particular circumstances on everything from biological materials, industrial materials, and even electrical components.
A stability chamber is responsible for reproducing temperature changes, humidity, and light for a specified time period. It functions similarly to a large refrigerator for scientific instruments. Stability test chambers are used to determine the shelf life of pharmaceutical items. It is critical for pharmaceutical businesses seeking to launch new medications
Types of Stability Chambers
-Environmental chambers
-Temperature – humidity chambers
Stability tests:
The following are some of the stability tests that must be conducted on a new product:
- Standard tests include appearance, assay, degradation products, microbiological testing, dissolution, and moisture on stability test samples.
- The ICH rules also encompass additional tests, such as enantiomeric purity, particle size, and polymorphic form.
- Light-resistance.
- Typically, stability tests are chosen based on their quality, purity, potency, and identification. This is due to the fact that during storage certain qualities are prone to alter.
- Integrity of packaging
- For liquid injectable solutions, for example, microbiological tests may include sterility, preservation efficacy, and bacteria count.
Specifications for the Selection of Stability Test Chambers:
Analyzing the units and how they help to the development of safe, effective medications that remain effective across the world's many climates is essential.
Control, conditioning, and construction are the three Cs : It is vital to ensure that the models considered meet the critical three Cs when selecting humidity and stability chambers.
- Conditioning: Across chamber interiors, temperature and humidity levels must be uniformly distributed. Electrically driven heaters with a cutout temperature prohibit the cabinet from surpassing its design limitations are used to heat the cabinet. The heaters are originally set although users can program it too.
- Construction: Its features include self-closing secure locking, stainless walls for cleanliness reasons, CFC-free foam concrete insulating material reducing the heat transmission, as well as a heater wire for door gasket that is anti-condensate and thermostatically controlled.
- Control: A completely programmable logic microprocessor is used to control the chamber. A single multifunction keypad controls all setpoints: ramp soak, product and ambient temperature, heating/cooling mode, humidity, door ajar, power failure, and sensor failure, etc.