Stability testing – Quality assurance right from the start
Convenient solution for stability testing
It takes a number of steps before active substances, drug products, vaccines, cosmetics and other items can obtain regulatory approval for the market. Part of this process includes stability tests, which are also known as shelf-life tests. The goal of these tests is to ensure sustained efficacy and prevent harmful effects in internal or external applications on living beings. When these types of products are stored or shipped, the manufacturer needs to know at what point, and under what conditions, they will begin to lose their effectiveness and when degradation will set in. This in turn affects the packaging, the expiration date, and the instructions for handling and storage. Especially when it comes to drugs and the active substances they contain, strict compliance with the specifications defined for stability and shelf-life is a must.
Quality control from the get-go
Stability tests are used for quality assurance in development, production, and packaging processes. If a product is to be marketed at a global level, the testing must take into consideration the different climates involved. This is especially true for the development of pharmaceuticals, vaccines, and biotechnological and diagnostic products, but it applies to homoeopathic drug products as well. Aside from the pharmaceutical industry, similar testing is also necessary in the food industry and the automotive field. In the latter case, raw materials must undergo stability testing because of their intermittent exposure to heavy loads, such as stresses occurring during rapid changes in temperature, meaning that climate is a significant factor here as well.
No regulatory approval without stability studies
In a stability test, every environmental condition that a product could be exposed to is simulated in a laboratory setting. For pharmaceutical and cosmetic products, as well as foodstuffs, this mainly concerns climatic influences, since temperature, light, and humidity can all have a negative impact on shelf-life and effectiveness. Once the relevant climate zone has been simulated, extensive microbiological, physical, or chemical analytics are performed as part of the stability study. Here, different parameters must be tested depending on the climate in which the product is to be used. This means that, in some cases, large-scale stability studies can be necessary, e.g., to account for all climate types when products are to be marketed globally.
Strict testing criteria help to ensure safety
The procedure for conducting stability tests on drugs is governed by the ICH Guidelines (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), of which ICH Quality Guidelines Q1A–Q1F play a particularly important role. The WHO (World Health Organization) and ICH work together to harmonize varying requirements in the different climate zones, which include the temperate, subtropical, and tropical climates. The U.S. Food and Drug Administration (FDA) also publishes its own stability testing guidelines based on the ICH requirements—for example, its “Guidance for Industry. Q1A(R2) Stability Testing of New Drug Substances and Products.”
To ensure that stability tests are conducted in compliance with applicable guidelines, certain specifications must be met. The challenge here is to design a self-contained testing environment that is capable of accurately simulating the parameters defined for a given climate zone.
Humidity test chamber – A cost-efficient solution
The environmental conditions found in each climate zone can be reproduced extremely accurately in the lab. It doesn’t even take much space to do so when testing active substances, pharmaceutical products or cosmetics. Humidity test chambers from BINDER are equipped with programmable temperature controls, humidifier devices, and light sources. The product under evaluation can be tested over a defined period of time with little effort and at a reasonable cost, eliminating the need to purchase a more expensive climate chamber.
Accuracy is the key requirement for ensuring product safety. Humidity test chambers from BINDER are perfectly equipped for a wide range of different applications. Each series is available in multiple sizes. One unique feature that comes standard on all chambers is the versatile water supply. That and the sturdy dual swivel casters that include a brake on larger systems make flexible setup in the lab simple and easy. In addition, a preheating chamber technology ensures that set climate parameters remain constant, even over longer periods of time. All humidity test chambers have been engineered to maintain the uniformity and consistency of the set climate conditions (temperature, humidity, light).
BINDER technology you can grow with
With 5 different series of humidity test chambers to choose from, BINDER does more than cover the broad spectrum of requirements for each customer’s individual climate parameters: Every single constant climate chamber can also be expanded to include a host of different accessories, such as a data logger, LED strip lights, illumination cassettes, additional racks, and more. This gives customers plenty of freedom to design their very own high-quality unit. The system hardware and software complement one another perfectly, and the interfaces provided allow users to record stability data, control processes, and monitor operation. This provides an optimal solution for documenting the results of the stability test.
Additional information and an overview of our constant climate chambers are available in this video.
For stability tests involving a simulation of the dynamic conditions found in some climates—such as material tests performed in the automotive industry —our dynamic climate chambers offer an ideal solution.