Stability Chamber New BR-700
₨300,000.00 – ₨400,000.00
Stability chamber BR-700
7 inches LCD with Touch Screen
Intervals can be selected for printing in this Stability Chamber
Built-in Data Logger
For storage of Temperature and Humidity data with Time & Date. It can Store about 1000+ set of Records
It can also be operated online by Logging in from your Mobile or PC
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Table of Content
- Stability Chamber and ICH Guidelines
- Stability Chamber as a Storage Chamber
- Stability chamber and warehouse storage challenges
- Suitable Solutions from El-lab
- Validation of stability chamber and warehouse processes
- Benefits of choosing El-lab data loggers for stability chambers and warehouse storage
Stability Chamber is a type of environmental Chamber that is designed and used to satisfy demanding environmental testing requirements with exceptional temperature and Humidity control. A stability chamber is also the type of environmental test chamber that is used to measure the particular circumstances on everything from biological materials, industrial materials and also used in electrical components. Stability Chamber plays a vital step in the development of new drugs and pharmaceuticals substances.
This is an essential element in the licensing process defined by federal regulation controls. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance of the stability chamber. Together with the help of experts in the pharmacy industry and assembly from the pharmaceutical industry and experts from the licensing authorities (Such as the FDA) have developed the ICH guidelines for the harmonization of stability tests.
The purpose of Stability testing is to provide evidence on how the quality of drug substances or drug products varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substances or shelf life for the drug.
- Stability Chamber and ICH Guidelines
In the pharmaceutical industry, stability testing helps provide evidence as to how the quality of the drug will vary with time under a variety of environmental conditions including temperature, humidity, and light exposure. This testing must be completed before a drug enters the market.
The guidelines for stability testing are outlined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and are observed by regulatory bodies worldwide including the Food & Drug Administration (FDA), European Commission (EC), and Health Canada. Six ICH guidelines—Q1A through Q1F—provide the specific details for adequate testing.
These guidelines are highly specific and require that the temperature in the stability chamber deviates by no more than 2 or 3°C depending on the condition and that humidity diverges by no more than five percent. Therefore, stability chambers used for this type of testing need to have low temperature and humidity deviations that have been observed over long testing periods. The temperature also needs to be uniform throughout the unit.
Stability chambers that use traditional non-directed airflow systems use a fan mounted at the top of the unit to push air down through wire shelves. When the shelves are filled with samples, this air movement will be blocked, leading to varying temperature conditions throughout the chamber. This inconsistency could compromise the stability conditions and the stability testing overall. In contrast, stability chambers that use a horizontal laminar airflow system include a positive pressure feed plenum on one side of the chamber and a negative pressure return plenum on the other to create horizontal airflow directed across the surface of each shelf.
Using this method means that, even when the shelves are filled with samples, they will receive a consistent flow of conditioned air allowing for optimum temperature uniformity throughout the chamber and across all samples. Horizontal laminar airflow systems also increase the capacity of the stability chambers by ensuring temperature uniformity even when the shelves are full, allowing for the testing of larger sample batches.
- Stability Chamber as Storage Chamber:
All pharmaceutical products must be placed on a stability trial. Even after approval, it is normal to have ongoing stability trials, which continually monitor quality throughout the lifetime of the product. Storage conditions in e.g., stability chambers and warehouses have been standardized to some degree.
Normal conditions are 25°C at 60% RH and 40°C at 75% RH. However, with biotechnology and the development of more biological products, storage at –20, -40 and even –80°C is not uncommon. Some products are stored in relatively small cabinets, but bulk materials are often stored in very large rooms or warehouses. It is important that the normal storage conditions do not deviate from those of the stability trials.
- Stability chamber and warehouse storage challenges:
Testing products for stability performance(s) is rather time-consuming, while the material costs are quite marginal, the overall costs are relatively high. Therefore, the quality of the test and data validity is of great importance. When it comes to storing the final product, be it in warehouses or freezers, can result in stocks of several million EUR being held in one place. The cost of a monitoring system with alarm conditions is insignificant compared to the cost of the product that it safeguards.
- Suitable Solutions from Ellab:
Ellab recommends using TrackSense® LAB Wireless Temperature Data Loggers and TrackSense® LAB Relative Humidity and Temperature Data Loggers that both are ideal for continuously monitoring and recording the temperature and humidity in stability chambers, environmental chambers, and warehouses. The data loggers are equipped with a LED and have various alarm functions, making it immediately clear when a cabinet strays from its normal conditions.
- Validation of stability chamber and warehouse processes:
Qualification of stability chambers, rooms, and warehouses do require similar standards as those applied to the qualification of autoclaves, ovens, etc. Especially for warehouses, one of the most important parameters is the calculation of MKT, Mean Kinetik Temperature, which is a part of the ValSuite™ Software. Some organizations rely on initial OQ to map cabinets and then continuous monitoring afterward.
However, more companies are realizing the need to increase their process validation effort with respect to stability chambers and therefore validate on an annual basis. Benefits of choosing Ellab data loggers for stability chambers and warehouse storage.
- Benefits of choosing Ellab data loggers for stability chambers and warehouse storage:
- Minimizes loss of product cost
- Built-in alarm functions
- Real-time data with SKY option
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