Italian Climate solutions for stability studies
The Il Disgelo Pharma & Cosmetics line is dedicated to stability testing in the pharmaceutical and cosmetics sectors and includes climatic chambers specifically designed to ensure precise environmental control, operational reliability and compliance with the main international standards.
The equipment in the line is designed and manufactured by Caelis, a French company specializing in the creation of climatic chambers for stability studies, and is distributed exclusively on the Italian market by Il Disgelo.
Thanks to this collaboration, the Italian market can count on solutions designed for the Pharma & Cosmetics sector and supported locally by Il Disgelo for installation, qualification and technical assistance.
The solutions available
The The Pharma & Cosmetics line includes:
- Monoblock climatic chambers
for laboratories and standard stability studies. - Walk-in climatic chambers
for applications requiring high storage capacity.
Both configurations are designed to ensure stability of environmental parameters, operational reliability and full compliance with pharmaceutical and cosmetics industry regulations.
Applications
The climatic chambers for stability testing are designed to ensure extremely precise and repeatable environmental conditions during long-term testing activities, essential for regulated and high-reliability industries.
They are suitable for applications such as:
pharmaceutical stability studies
cosmetic stability studies
accelerated aging tests
photostability studies
product validation and shelf-life determination
research and development (R&D) activities
These applications require continuous and controlled maintenance of temperature and relative humidity over extended periods, ensuring high environmental stability and maximum test repeatability.
Compliance with International Standards
The solutions are designed to operate in compliance with the main international standards and regulatory references for the pharmaceutical and cosmetics industries:
ICH Guidelines
ICH Q1A(R)
ICH Q1B (Option 2)
FDA
GLP / GMP
21 CFR Part 210 and 211
The climatic chambers are developed to meet the requirements typically requested during regulatory audits and inspections, ensuring:
continuous data traceability
constant monitoring of environmental parameters
high operational reliability
secure alarm and event management
Climatic Performance
The chambers are engineered to provide high precision, stability, and uniformity of environmental conditions, even during continuous 24/7 operation.
Typical Operating Specifications
Available volumes: from 600 to 2000 liters
Temperature range: from +15 °C to +60 °C
Relative humidity range: from 10 % to 90 % RH
Typical uniformity: ±0.3 °C / ±1.5 % RH
The advanced airflow management and system architecture ensure uniform climatic conditions throughout the entire working volume, providing maximum reliability during long-term stability studies.
Control System
The equipment is fitted with a digital touchscreen control system designed for the complete management of stability studies and regulated climatic testing.
Main Functions
continuous monitoring of environmental parameters
process data recording and storage
full event traceability
acoustic and visual alarm management
test cycle programming
real-time operational supervision
The operator interface is designed to ensure ease of use, operational continuity, and immediate access to test data, simplifying laboratory activities and validation procedures.
Installation, qualifications and support
Available services:
- Installation and commissioning
- IQ Qualifications (Installation Qualification
- OQ Qualifications (Operational Qualification)
- PQ Qualifications (Performance Qualification)
- Preventive maintenance
- Specialized technical support
This approach ensures business continuity, data reliability, and technical support throughout the equipment lifecycle.
Reliability in stability testing
In the Pharma & Cosmetics industry, stability of environmental parameters is critical to the validity of study results.
This solutions are designed to ensure:
- stability and homogeneity of parameters over time
- operational continuity during long-term studies
- reliability of data during audits and inspections
Because behind every reliable stability study is an uncompromisingly designed test environment.
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