Stability Testing of Active Drug Substances and Prescribed Drugs

October 20 , 2022
Stability testing is a study designed to provide information on how an active pharmaceutical ingredient or completed pharmaceutical program is affected by temperature, humidity, climate and light over time. Compliance check durations, expiration dates and recommended storage conditions for active pharmaceutical substances are derived from this information, and stable compartments are essential when conducting these studies.

Stability Chamber - Survival of the Fittest

Reliability and repeatability, dependability and robustness of factors in an ongoing procedure will be the best goals for a stable maintenance chamber. The solid stainless steel inside must be resistant to ageing and easy to clean. Coding should be easy to use, and calibration certificates, info loggers and verification documents should of course be included.

Environmental Test Chamber for stability compartments in the pharmaceutical industry

What practical options are currently available to meet these requirements? Which elements must I pay particular attention to? What are the pros and cons of the various practical options? This website provides you with original information.

1. Damp heat inspection and insulation room

The constant temperature and humidity chamber quickly decomposes all attainable ideal values of temperature and humidity. Efficiency options generally differ for the various stabilization compartments. For example, some models satisfy each of the weather conditions given in the ICH recommendations and the conditions for the five weather regions given in the ICH recommendations. This model is very general and can be combined together as a general backup if needed. Other models only simulate some weather conditions, so they have very few procedures.

2. Horizontal or top-down airflow

With side-to-side airflow, the air is evenly distributed on each shelf, regardless of the shelf's condition in the stable holding chamber. Optimum temperature and humidity cycling is achieved when starting the holding chamber. The same is true for the issue of lateral airflow on both sides.

In the matter of air flowing from top to bottom, i.e. bottom to top, the air diffuses through the rack, starting at the bottom, increasing the center, and eventually reaching the best rack. Each shelf basically disables oxygen circulation.

3. Humidifying water

It's not just the type of humidification that matters - the liquid supplied to the stabilization holding chamber also needs to be of good quality. A water supply and drainage site attached to the site is only one option, when using a bulk tank to provide fresh water and keep the indoor accumulation of wastewater directly in stabilization is another option. The second option allows the holding chamber to be installed away from the water supply on the site. In both cases, the ion exchanger will prepare the fresh water to the desired quality.

4. Continuous program

The stable maintenance chamber works continuously for more than 8,000 times a year. Robust models, solid resources and components developed for optimum credibility will be the foundation, ensuring that these tough operating situations will last a long time.

In order to be able to reduce the chance of time-consuming cross-contamination and to control internal biocontamination, there is a complete need for an interior that is easy to thoroughly clean.

Substantial alloy stainless steel, removable racks, steam humidification and lack of synthetic resources inside are just some of the elements that matter. Some models also offer a long temperature range of up to 100°C, which means sterilization is possible.

5. Coding and recording

A key point in relation to approved software will be the availability of complete and complete documentation of all relevant factors under each operating condition. Needless to say, calibration certificates for temperature, climate, information loggers (method file independent information recording) and confirmation documents with IQ (setup qualification), OQ (function qualification) and PQ (performance qualification).

If you have any questions about our Medical Stability Test Chamber, please contact us at
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