Custom Solutions for High-Capacity Pharmaceutical and Cosmetic Stability Studies
The Walk-In climatic chambers within the Il Disgelo Pharma & Cosmetics line are systems designed for pharmaceutical and cosmetic stability studies requiring large product storage volumes, while maintaining controlled temperature and relative humidity conditions over extended periods.
The equipment is designed and manufactured in France by Caelis and distributed in Italy by Il Disgelo, which provides installation, commissioning, qualification and technical support throughout the national territory.
The Walk-In chambers are designed for continuous 24/7 operation and can be custom-built according to the required volume, laboratory layout, quantity of stored products and shelving arrangement.
Configurations can range from several tens of cubic metres to more than 80 m³ of usable volume, while maintaining uniform air distribution and stable climatic conditions even under high product loads.
The design is defined according to application requirements, required climatic conditions and laboratory qualification needs. The configurations shown in the table therefore represent technical reference examples only and do not constitute fixed standard models.
They are designed to provide:
- precise temperature and relative humidity control;
- stable and repeatable climatic conditions;
- continuous 24/7 operation;
- high climatic uniformity throughout the usable volume;
- storage of large quantities of samples and products;
- integration with high-density shelving systems;
- fully customizable dimensions and layouts;
- continuous monitoring of climatic parameters;
- data recording and traceability;
- integrated alarm and safety management.
- type: Walk-In climatic chambers for stability studies;
- application: pharmaceutical and cosmetic sectors;
- configuration: modular and custom-built;
- operation: designed for continuous 24/7 use;
- usable volume: configurable according to project requirements, from several tens of cubic metres to more than 80 m³;
- temperature range:+15 °C to +55 °C;
- temperature accuracy:±0.1 °C;
- temperature stability:< ±0.5 °C;
- temperature uniformity:±1 °C;
- relative humidity range:20% to 98% RH;
- humidity accuracy:±0.5% RH;
- humidity stability:< ±1% RH;
- humidity uniformity:±3% RH;
- humidification: ultrasonic humidification system;
- dehumidification: through the refrigeration circuit;
- air treatment: dedicated AHU;
- air distribution: forced ventilation with ceiling-mounted textile duct;
- insulated panels:60 mm sandwich panels;
- fire reaction classification:B s2 d0 (M1);
- surface finish: smooth internal and external sheet metal, RAL 9010;
- floor: insulated, with load capacity up to 3,000 kg/m² distributed load;
- door: hinged door with four-seal system;
- reference clear door opening:2000 × 900 mm;
- anti-condensation system: integrated heating cable;
- door safety: panic bar and internal emergency release;
- control:7” touchscreen;
- user management: up to 100 configurable users;
- data export: USB port;
- recording: events, parameters and alarms;
- safety systems: independent safety thermostat, audible and visual alarms, dry contacts, emergency stop, internal emergency lighting and internal alarm button.
Reference Configuration
The following table shows one example of a completed configuration. Walk-In chambers can be dimensioned and designed to suit the required volume, available layout and storage needs.
| PARAMETER | REFERENCE CONFIGURATION |
|---|---|
| Usable volume | Approx. 79 m³ |
| Internal dimensions | 2700 × 3900 × 7500 mm |
| External dimensions | 2890 × 4050 × 7650 mm |
ICH Climatic Conditions
The chambers can be configured to operate under the main conditions commonly used for stability studies:
- 25 °C / 60% RH
- 30 °C / 65% RH
- 30 °C / 75% RH
- 40 °C / 75% RH
Additional climatic conditions can be defined according to application and project requirements.
Configurable Data
The values shown represent reference technical configurations. Usable volume, internal and external dimensions, shelving arrangement, number and size of doors, air-distribution system, AHU configuration, technical feedthroughs, monitoring systems and optional equipment can be defined according to the project.
The Walk-In climatic chambers are therefore dimensioned by considering available layout, quantity and type of product, storage density, required climatic conditions, thermal load, study duration and qualification requirements.
- Fully customizable dimensions and volumes
- Custom-designed internal layout
- Dedicated shelving and storage systems
- Additional doors or doors in different dimensions
- Additional technical feedthroughs
- Dedicated internal lighting
- Supplementary monitoring systems
- Dry contacts for external supervision systems
- Dedicated solutions for data recording and traceability
- Specific configurations for different climatic conditions
- Additional safety systems
- Configurations dedicated to integration within the laboratory layout
- Installation and commissioning
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- Preventive maintenance
- Specialized technical support
- Periodic performance verification
Note: dimensions, volumes and configurations are defined according to the specific project. The dimensional data shown in the table are provided solely as a reference example and do not represent a fixed range of standard models.
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