To meet the great variety of needs from its customers, USIFROID has designed its production-scale freeze-dryers following the modular concept: each machine is an assembly of pre-validated modules which are based on proven technologies and designs.
Freeze-dryers have been divided into different parts, for which standard modules have been developed :
- Chamber and shelves
- Condenser
- Stoppering system
- Refrigeration system
- Vacuum system
- Electrical panel and control system
Using fully integrated computer aided design, the whole freeze-dryer is rapidly defined. This way, USIFROID can build in minimum time a reliable freeze-dryer which fully matches the customer’s requirements.
The modular range SMH is also the best solution to accommodate specific layout arrangements while maintaining an easy access for the maintenance.
In addition to those standards modules, some applications may require specific development related to the lyophilisation process, or to the environment of the freeze-dryer. Based on its modular range of products, USIFROID can propose fully engineered solutions to match special requirements.
FEATURES
- 316L construction for chambers & all product contact surfaces
- Condenser : internal or external, positioned behind, on the side, above or below the product chamber
- Combination of pre-tested modules (chamber and shelves, condenser, refrigeration system, vacuum system, electrical panel and control system) to meet the great variety of needs from customers
- Sterilisation in place
- Cleaning in place
- WIT
- Compliance to FDA, cGMP regulations
- User-friendly control system compliant to 21 CFR Part 11 and developed according to cGAMP
WIDE RANGE OF OPTIONS AVAILABLE
Including:
- Hydraulic stoppering system, screw stoppering system (patented design)
- Separating valve between the chamber and the condenser
- Adjustable stoppering force
- Constant height level loading
- Shelf re-spacing
- LN2 cooling system in place of compressors
- Redundant cooling and/or vacuum system
- Redundant circulation pump
- Type of door
- Customised design for specific applications
SERVICES
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Qualification (DQ / OQ / IQ)
- Maintenance contract
- Training course