ICH Stability Chamber for the Pharmaceutical INdustry

Pharmaceutical Stability Testing :Mastering ICH Compliance Over Time

The pharmaceutical industry is at a turning point. Today, the strict requirements of health authorities are compounded by a complex reality on the ground: aging climate control facilities, the progressive ban on older refrigerants (F-Gas regulations), and the need to control energy costs.

For an R&D laboratory, a production unit, or a storage site, the challenge is no longer just being compliant on the day of the audit. It is maintaining this compliance over time, without risking the loss of a batch or the interruption of a long-term stability study.

It is precisely to meet this urgent need that Caelis forged its identity. As a specialist in ICH stability studies, Caelis supports pharmaceutical laboratories, production units, and GDP storage sites in mastering their regulated climatic conditions. As a French designer and manufacturer based near Toulouse, our DNA is built on a sharp specialization: expertise in pharmaceutical stability. We are not merely resellers of standardized equipment. We design, qualify, and maintain long-lasting climate solutions capable of meeting the most complex projects, both in France and internationally.

Our commitment? To turn your constraints (ICH, FDA, GMP, GDP, IQ/OQ/PQ qualification) into a guarantee of peace of mind, thanks to long-term support focused on the absolute mastery of industrial risk.

ICH Stability Chambers and Walk-ins: Certified Equipment for Your Stability Studies

AIn the field, your protocols require flawless mechanics capable of running without interruption. Whether you manage formulation development, quality control, or regulated storage of very large volumes, our equipment adapts to your processes.

Manufactured in France, our ICH stability chambers and Walk-in infrastructures guarantee the homogeneity and reproducibility required by your stability studies and process validations:

• ‍25°C / 60% HR ; 30°C / 65% HR ; 25°C / 40% HR ; 30°C / 35% HR for your long-term stability studies.
• ‍30°C / 65% HR ; 30°C / 65% HR for intermediate conditions.
• ‍40°C / 75% HR ; 40°C / 25% HR to anticipate shelf life via our accelerated aging chambers.
• Photostability testing with calibrated and fully auditable UV/Visible lighting (ICH Q1B).
• ‍5°C ; -20°C ; -80°C for thermosensitive storage at negative or ultra-low temperatures for vaccines and biological products.

ChaquEach ICH stability chamber is delivered with its comprehensive qualification documentation (IQ/OQ/PQ) and data records compliant with FDA 21 CFR Part 11 and GMP requirements. The equipment can be qualified according to your internal procedures and is auditable during your regulatory inspections.

From the ready-to-use monoblock chamber for your laboratory to the custom-integrated modular chamber (Walk-in) in your laboratories or logistics warehouses, each piece of equipment is delivered with its complete qualification documentation.

Retrofit, Custom-Made, and Energy Optimization: The Caelis Approach

Because evolving your infrastructure doesn't always mean buying new equipment, Caelis deploys a comprehensive approach to ensure the longevity of your fleet.

Retrofit: Modernizing your existing chambers

Your chambers are aging, but the structure remains sound? We replace obsolete PLCs and substitute your old refrigerants with new-generation gases (compliant with environmental standards). You extend the lifespan of your fleet while spreading out your capital investments.

New Stability Chambers: From R&D Monoblocks to Industrial Walk-ins

The monoblock chamber: "Plug & Play" for R&D. A reduced footprint and immediate start-up, ideal for quickly securing new protocols.

Modular and Walk-in chambers: Industrial capacity. Custom infrastructures to manage large volumes (contract manufacturing, biobanks, GDP storage), with foolproof maintenance of climatic conditions, even on a very large scale.

Proprietary Technologies: Reducing your consumption without compromising stability

We integrate our own technologies to rethink the thermal balance of your cooling systems. The result: a drastic reduction in your electricity consumption without any compromise on the stability of your tests.

Comprehensive Support: From IQ/OQ/PQ qualification to inspection support

From the initial audit to international deployment, including preventive maintenance and support during your inspections, Caelis is committed for the long term. We are by your side so that your equipment is never the weakest link in your value chain.

A qualification, renewal, or retrofit project to entrust to us?