
If the quality and safety of all the products we consume are important, this is crucial in the pharmaceutical sector.
Pharmaceutical Climate chambers play a crucial role in this process, allowing the stability of products to be tested in controlled environmental conditions.
In today's article we will see how these laboratory instruments operate, what types of tests can be performed and above all how to choose the pharmaceutical climate chamber that is right for our needs, with particular attention to its size.
What are Pharmaceutical Climate Chambers Used For
Pharmaceutical Climate chambers are laboratory instruments that are used to recreate precise and reproducible environmental conditions.
Their main function is to perform stability tests on pharmaceutical products, ensuring that they maintain their efficacy and safety in different climatic conditions. These tests are essential to meet regulatory requirements and to ensure the quality of products before they are placed on the market.
Here's how they work: pharmaceutical climate chambers consist of a compartment isolated from the outside and within which it is possible to alter and control a series of fundamental parameters such as temperature, humidity and light.
The temperature can be kept stable or subjected to cyclical variations, while humidity is regulated to simulate different environmental conditions, from dry to very humid climates. Some models are equipped with specific lighting systems for photostability tests, allowing the effect of natural and artificial light on products to be evaluated. All these parameters are managed through high-precision sensors and advanced control systems, ensuring the reproducibility of the tests.
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The Main Tests in Pharmaceutical Climate Chambers
Le camere climatiche farmaceutiche vengono utilizzate per condurre diversi test fondamentali nel settore:
- Stability tests: they are used to determine the shelf life of drugs and how their chemical and physical characteristics vary over time.
- Photostability tests: they verify the sensitivity of pharmaceutical products to exposure to light, simulating real storage conditions.
- Research and development (R&D) tests: these are conducted to improve drug formulations and ensure their resistance to different environmental conditions.
All these tests must comply with international regulations such as the ICH (International Council for Harmonisation) guidelines and good laboratory practices (GLP). In particular, the ICH Q1A(R2) guidelines for stability tests and ICH Q1B for photostability tests provide precise indications on the parameters to monitor and the methodologies to follow to ensure the quality of pharmaceutical products over time.
Selection of the Pharmaceutical Climate Chamber
One of the most underestimated aspects in the choice of the pharmaceutical climate chamber is its size. Depending on the internal volume, in fact, pharmaceutical climate chambers can be divided into four distinct categories.
- Benchtop climate chambers: ideal for small laboratory tests and for limited quantities of samples. Volume range: 100-400L
- Medium-sized climate chambers: used for testing larger volumes of products and/or samples. Volume range: 400-800L
- Large climate chambers: suitable for large-scale production and extended stability testing. Volume range: 800-1500L
- Walk-in chambers: designed to test entire batches of drugs or products on a large scale. Volume range: over 1500L
To help you choose the climate chamber that best suits your needs, in the attached White Paper you will find a detailed table indicating which types of tests can be performed with each category of chamber.
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Pharmaceutical climate chambers by FDM
FDM - Environment Makers’ pharmaceutical climate chambers are designed to conduct all the fundamental tests required by the industry.
In addition, our engineers are always available to design the ideal solution based on the specific needs of each customer.
Download the White Paper below and contact us to learn more!
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