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.
Applications
The climatic chambers The Thaw Pharma & Cosmetics are designed for:
- pharmaceutical stability studies
- cosmetic stability studies
- accelerated testing
- photostability studies
- product validation and shelf-life
- research and development activities
These applications require extremely stable test environments that can maintain constant temperature and humidity conditions for extended periods.
Compliance with international standards
The solutions in the Il Disgel Pharma & Cosmetics line are designed to operate in compliance with major industry standards:
- ICH Guidelines
- ICH Q1A(R)
- ICH Q1B (Option 2)
- FDA
- GLP / GMP
- 21 CFR Part 210 and 211
The design of climate chambers takes into account requirements during regulatory audits and inspections, ensuring data traceability and continuous monitoring of environmental parameters.
Climatic Performance.
The chambers in the The Pharma & Cosmetics Thaw line are designed to ensure high stability and homogeneity of environmental parameters.
Typical operating specifications:
- Available volumes: 600 to 2000 liters
- Temperature range: +15 °C ÷ +60 °C
- Relative humidity: 10 % ÷ 90 % RH
- Homogeneity: ±0.3 °C / ±1.5 % RH
The equipment is designed to operate 24/7, ensuring stability of parameters and continuity of testing during long-term studies.
Control system.
The climatic chambers are equipped with digital control system with ergonomic touchscreen interface for managing test cycles.
Main functions:
- continuous monitoring of environmental parameters
- data logging and tracking
- management of acoustic and visual alarms
- programming of test cycles
The system enables complete management of stability studies and data traceability throughout the test cycle.
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.
The solutions available
The The Pharma & Cosmetics Thaw line includes:
One-piece 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.
Reliability in stability testing
In the Pharma & Cosmetics industry, stability of environmental parameters is critical to the validity of study results.
Il Diselo Pharma & Cosmetics 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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