Stability Chambers and It’s Features
In the medical industry, stability testing gives evidences to show that the nature of a medication will shift with time under an assortment of ecological conditions including temperature, humidity, and light exposure. This testing should be finished before a medication enters the market.
To test the nature of the medication under specific temperature and humidity, a cluster of the medication is placed in a stability chamber that has controlled temperature and humidity for a predefined measure of time. Tests are checked periodically for quality examination. Since stability testing happens over intervals of time going from one week, to a half year, to one year or more, the stability chambers should be consistent and reliable.
Thermolab’s unique range of differentiating technologies and services ensure that its clients receive the most innovative and effective solutions to their needs. With 5 decades of rich experience, Thermolab is one of the best stability chamber manufacturers in India that provides all technical grids under one roof, effectively matching its client’s expectations.
Thermolab Scientific Chambers are perfectly designed to meet the requirements of stability studies and climatic tests. They are specifically developed to meet FDA/ICH stability requirements generating exceptional control and uniformity of both temperature and humidity. Thermolab’s Stability Chambers feature various safety features, audio visual alarms, 21 CFR part 11 software and a vast range of options which makes them a preferred choice for stability studies. These equipments repeatedly produces required conditions, structural integrity that keeps the chamber working properly through years of demanding test cycles and measuring equipment’s that precisely records all test data.
Standard Features:
- Double walled modular structure with 3” thick PUF insulation.
- Inside Stainless Steel and Outside Mild Steel Powder Coated OR Stainless Steel.
- Handle and hinges for positive sealing with lock and key arrangement.
- Heavy-duty door hinges and latches to maintain a secure and uniform seal.
- Humidity system with evaporation tray and reservoir tank with water level arrangement.
- 65 mm Port Hole with rubber seal to insert sensors for validation purpose.
- Compressor with CFC Free R 134 A / R 404 (Eco Friendly) refrigerant having state of art by-pass system for continuous run of compressor
Optional Features:
- 21 CFR Part 11 Compliance Window based communication software for data management.
- Stand by refrigeration system & Stand by humidity system (Except for 90 Ltrs).
- Scanner 4 point temperature and 4 point humidity scanner complete with sensors and printer interface and data storage facility Door Access Security system.
Specifications:
- Standard Model(S) : Inside S.S. 304 with mirror polish & outside mild
- GMP Model(G) : Inside S.S. 304 with mirror polish & outside with S.S. 304 matt buff
- Temperature Range : 20°C to 60°C
- Temperature Accuracy : ± 0.2°C
- Temp Uniformity : ± 2°C
- Humidity Range : 40% to 95% RH
- Humidity Accuracy : ± 2% RH
- Humidity Uniformity : ± 3% RH
In the uncommon occasion that your medicine’s lab isn’t running stability testing, stability chambers can be valuable for different applications. For instance, since they keep up steady temperature and humidity, they make extraordinary capacity vessels for tests that should be kept in stable conditions.
Stability testing for the medication industry requires a major time investment and choosing the right instrument should not be taken for granted. Stability chambers used to test drugs for stability under varying temperature, humidity, and light exposure need to be reliable, stable, and adhere to ICH guidelines. Thermolab’s Stability Chambers fulfill all of these needs as they maintain consistent temperature over time and provide multiple features that adhere to FDA/ICH guidelines.