Testing is the only way to ensure that a drug meets the outcome that it is expected to achieve. The quality of the drug depends on various factors such as environmental conditions that include temperature, humidity, and its reaction to light. Testing is essential before the drug is introduced to the market. Quality analyses of samples determine their efficacy and therefore stability testing in a stability chamber is the surest way to measure the shelf life and the safety of the drug.
How does a stability chamber work?
The stability chamber maintains the relative humidity (RH) and temperature in its chamber. The working of the stability chamber is based on the principle of physics that the higher the temperature the more the capacity of the air to retain humidity. Stability chambers replicate natural conditions artificially for pharmaceutical companies. Medicines can be exposed to various environmental conditions with help of the stability chamber. It also helps pharmacists understand the adjustment of medicine and its accelerated effects when exposed to certain atmospheres that may be adverse for the medicine. It offers insight into how the medicines can be enhanced to suit all area and climate types.
How does the stability chamber in a pharmaceutical work?
Various factors must be considered before a drug is ready for the market. Among the several procedures of testing comes the stability testing of a drug. This helps to understand how the drug will vary with time, under different environments (temperature, humidity, and light exposure). This testing is crucial before the drug is sent to the market.
The stability chamber can control temperature and humidity for a specific period when a batch of medicines are put in the chamber and checked for quality analysis. The testing takes place over a period which could be anywhere from a week to months or more than a year. Therefore, the stability chamber needs to maintain consistency and quality. The stability of the drug to light and UV light is another important consideration. A photostability chamber that can emit UV light and visible light for a long period is used.
ICH Stability Testing Guidelines.
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), followed by the regulatory bodies worldwide state six guideline Q1A-Q1F. Specific details have been laid down for adequate testing.
The temperature within the stability chamber should not deviate more than 2-3 °C, humidity must not vary by more than 5%. Therefore, the stability chamber that is used for this type of testing should have low temperature and humidity deviations for the length of the testing period.
The unit should maintain a uniform temperature throughout. The chamber supporting non-direct airflow, using a fan mounted at the top of the unit, will push the air through the wire shelves. However, if the shelves are filled with samples, the air movement will be blocked, and this would lead to a temperature difference within the chamber. Thus, the stability testing for overall samples in that chamber will be compromised.
Conversely, a stability chamber using horizontal laminar airflow will exert positive pressure feed plenum on one side of the chamber and negative pressure return plenum on the other side. This creates a horizontal airflow that is directed across the surface of each shelf. The advantage of horizontal airflow is that it maintains stable and consistent airflow even when the shelves are blocked with samples. Maintaining uniformity, they are ideal for large sample batch testing.
Why choose Igenels?
Choosing the right stability chamber is crucial and a trusted and reliable company like https://www.igenels.com who maintain quality and product efficiency is a natural choice.
Features:
- Built on a rigid stainless-steel frame, thick gauge 304-316 is used.
- High-density PUF insulation between inner and external chambers
- The temperature range is from 10°C to 60°C, humidity range 35% to 95% RH.
- Following ICH guideline of storage condition 25°C at 60% RH, 40°C at 75% RH, 30°C at 65% RH and 25°C at 40% RH.
- CFC free refrigeration compressors, hermetically sealed with noiseless operation.
- SS Tubular air heater generated warm chamber temperature.
- Automatic water filling and low water safety devise, ISI mark immersion heater to maintain humidity.
- Motorized blower assembly for uniform air circulation and noise-free long service life.
- Self-programmed PID Control, featuring set and processed value. PCL Based HMI controller featuring color touch screen, can be programmed on customer specifics.
- LED/Florescent lights, cycle timer, Auto ON/OFF.
- Temperature, temperature variation and current protected.
- Data logging features.