Climatic Chamber Configurator
Discover the Climatic Chamber Configurator
Our guide to choosing the climate chamber best suited to your needs.
While the quality and safety of all the products we consume is important, this is crucial in the pharmaceutical sector.
play climate chambers Pharmaceutical a crucial role in this process, allowing product stability to be tested under controlled environmental conditions.
In today's article, we'll look at how these laboratory instruments work, what types of tests they can perform , and, most importantly, how to choose the right pharmaceutical climate chamber for your needs, paying particular attention to its size.
What are Pharmaceutical Climate Chambers Used For?
Pharmaceutical climate chambers are laboratory instruments used to recreate precise and reproducible environmental conditions.
Their primary function is to perform stability tests on pharmaceutical products, ensuring they maintain their efficacy and safety under various climatic conditions. These tests are essential to meeting regulatory requirements and ensuring product quality before they are released to 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 parameterssuch as temperature, humidity and light.
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 test reproducibility.
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The main tests in pharmaceutical climatic chambers
Pharmaceutical climate chambers are used to conduct several fundamental tests in the industry:
- Stability tests: These are used to determine the shelf life of drugs and how their chemical and physical characteristics change over time.
- Photostability tests: these tests verify the sensitivity of pharmaceutical products to exposure to light, simulating real-life 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 Harmonization) guidelines and good laboratory practices (GLP). In particular, the ICH Q1A(R2) guidelines for stability testing and ICH Q1B for photostability testing 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 climatic chamber
One of the most overlooked aspects when choosing a pharmaceutical climate chamber is its size. Depending on their internal volume, pharmaceutical climate chambers can be divided into four distinct categories.
- Benchtop climate chambers: ideal for small laboratory tests and limited sample quantities. Volume range: 100-400L
- Medium-sized climatic 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
- chambers Walk-in: Designed for testing entire batches of drugs or products on a large scale. Volume range: greater than 1500L
To help you choose the climatic chamber best suited to your needs, the attached White Paper provides a detailed table indicating the types of tests that can be performed with each chamber category.
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FDM Pharmaceutical Climate Chambers
FDM – Environment Makers ’ pharmaceutical climate chambers are designed to conduct all the essential tests required by the industry.
Furthermore, our technicians are always available to design the ideal solution based on each customer's specific needs.
Download the white paper below and contact us to learn more!
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ICH Conditions for Pharmaceutical Stability Testing
The ICH Q1A(R2) guidelines define standardized conditions for stability tests depending on the climatic zone of destination of the product:
| Type of study | Temperature | Relative humidity | Minimum duration | Frequency of sampling |
|---|---|---|---|---|
| Long term (Zone II) | 25 ± 2 °C | 60 ± 5% RH | 12 months (registration) | 0, 3, 6, 9, 12, 18, 24, 36 months |
| Long term (Zone IVb) | 30 ± 2 °C | 75 ± 5% RH | 12 months | 0, 3, 6, 9, 12, 18, 24, 36 months |
| Intermediate | 30 ± 2 °C | 65 ± 5% RH | 6 months | 0, 6, 9, 12 months |
| Accelerated | 40 ± 2 °C | 75 ± 5% RH | 6 months | 0, 3, 6 months |
| Photostability (ICH Q1B) | 25 °C | Controlled | Option 1/2 | 1.2 M lux h + 200 W h/m² UV |
Reference Regulations for the Pharmaceutical Sector
- ICH Q1A(R2) — Stability Testing of New Drug Substances and Products
- ICH Q1B — Photostability Testing
- ICH Q1C — Stability testing for new dosage forms
- ICH Q1D — Bracketing and matrixing designs
- ICH Q1E — Evaluation of stability data
- EU GMP Annex 1 — Manufacture of Sterile Medicinal Products
- EU GMP Annex 15 — Qualification and Validation
- FDA 21 CFR Part 211 — cGMP for Finished Pharmaceuticals
- WHO TRS 1010 Annex 10 — Stability testing of active pharmaceutical ingredients
- USP — Good Storage and Distribution Practices
Authoritative Sources and External Links
- ICH — International Council for Harmonisation — Official document Q1A(R2) and complete set of guidelines.
- EMA — European Medicines Agency — European guidelines on pharmaceutical quality and stability.
- FDA — Drug Guidance — Official documentation on 21 CFR Part 211 and stability testing.
- AIFA — Italian Medicines Agency — Italian regulatory authority for GMP audits.
Frequently Asked Questions about Pharmaceutical Environmental Chambers
What tolerances must an ICH test chamber guarantee?
The ICH Q1A(R2) standard requires ±2°C temperature and ±5% RH humidity at set point. FDM ICH chambers far exceed these requirements with uniformity of ±0.5°C and ±2.5% RH, a requirement for IQ/OQ/PQ thermal mapping and to ensure operating margin for extended studies of 36+ months. IQ/OQ/PQ qualification is a mandatory prerequisite for GMP studies.
Do you need a different chamber for each ICH condition?
Not necessarily. Many chambers can cover all ICH set points (25/60, 30/65, 40/75, 25°C for photostability) at different times. In practice, however, laboratories with continuous production use dedicated chambers for each condition to avoid interruptions. FDM walk-in chambers support up to 4 independent climate zones in the same cabinet.
What happens if the chamber goes out of ICH range during the study?
The guidelines require that any deviationsbe documented in the Quality Assurance form with a stability impact analysis. Short-term deviations (<24 hours) within reasonable limits are generally accepted; prolonged deviations may invalidate the study. This is why a continuous monitoring system (audit trail 21 CFR Part 11) is critical: the FDM chamber automatically records every deviation with multi-threshold alarms.
Are pharmaceutical climate chambers only for finished drugs?
No. They are also used for APIs (Active Pharmaceutical Ingredients) in the development phase, excipients, primary packaging (blisters, bottles, seals) for container-content compatibility tests, medical devices (ISO 13485/IEC 60601) and cosmetic shelf-life studies according to EU Regulation 1223/2009. The veterinary industry and master pharmaceuticals also use the same ICH conditions.
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Do you need to pass a regulatory test or are you looking for a chamber designed to your test protocol? Tell us your needs: the FDM technical team will respond to you, without intermediaries.
