Stability testing of active pharmaceutical ingredients and finished drugs

Stability testing is a study designed to provide information on how an active pharmaceutical ingredient or finished pharmaceutical product is affected by temperature, humidity, climate and light over time. The duration of follow-up inspections, expiration dates and recommended storage conditions for active pharmaceutical ingredients are based on these data, and stability chambers are essential when conducting these studies.

Stability Chamber - Survival of the Fittest
Accuracy and repeatability of parameters in continuous operation, reliability and durability are the top priorities of the stabilization chamber. The solid stainless steel interior should be corrosion resistant and designed to be easy to clean. Programming must be intuitive, and calibration certificates, data loggers and validation documentation should of course be included.

Basic requirements for stability chambers in the pharmaceutical industry
What technical solutions are currently available to meet these requirements? What factors must I pay special attention to? What are the advantages and disadvantages of various technical solutions? This blog provides you with initial insights.

1. Temperature and humidity test chamber
The temperature humidity chamber provides a quick overview of all achievable temperature and humidity values. The performance range of different stabilization chambers varies widely. For example, some models satisfy the conditions of five climatic zones I to IVb in addition to all the climatic conditions specified in the ICH guidelines. Such models are very generic and can be combined with each other as generic backups if desired. Other models only simulate certain climatic conditions, so their application is very limited.

2. Horizontal or vertical airflow
With horizontal airflow, the air spreads evenly on each shelf regardless of the shelf's position in the stabilization chamber. Optimum temperature and humidity distribution is achieved when loading the chamber. This is especially true in the case of double-sided horizontal airflow.

In the case of vertical airflow, i.e. from bottom to top, the air diffuses through the shelves, starting at the bottom, going up the middle, and finally reaching the top shelf. Each shelf basically blocks air distribution.

3. Humidifying water
It's not just the type of humidification that matters - the water supplied to the stabilization chamber must also be of good quality. Connecting to an on-site water supply and drainage facility is one option, while using bulk tanks to supply fresh water and collect wastewater directly in the stabilization chamber is another option. The latter option allows the chamber to be installed away from the on-site water supply. In both cases, the ion exchanger will prepare the fresh water to the desired quality.

4. Continuous operation
The stability chamber operates continuously for more than 8,000 hours per year. Robust designs, durable materials and components developed for maximum reliability are the foundations, ensuring these demanding operating times will last for years.

In order to minimize the risk of time-consuming cross-contamination and stabilize indoor biocontamination, an easy-to-clean interior is absolutely necessary.

High-alloy stainless steel, removable shelves, steam humidification and the absence of synthetic materials inside are just some of the key aspects. Some models also have an extended temperature range of up to 100°C, which means sterilization is possible.

5. Programming and Documentation
An important factor regarding approval applications is the availability of complete and end-to-end documentation of all relevant parameters for each operational state. Needless to say, calibration certificates for temperature, climate, data loggers (process documentation independent data records), and verification documents with IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).


If you have any questions about our stability chamber, you are welcome to contact us at thchamber.com.