Pharmaceutical Freeze Dryer Systems
Freeze-drying systems are suitable for the stabilization of thermolabile and sensitive active substances, such as oncological medicines, vaccines or antibodies.
The modular concept, for vertical as well as for horizontal design, offers the advantage of being suitable for the entire range of GMP-compliant machines, starting with the production of small quantities e.g. for clinical studies up to large production batches. The scalability from small to large production systems as well as the easy adaption to the respective layout situation represent further benefits of the comprehensive modularization.
In addition to the energy-efficient lyophilization process, which is characterized by high process reliability, the freeze dryer also includes all secondary processes such as CIP, SIP and WIT with short cycle times and thus ensures reliable product quality in large quantities.
Defined interfaces to upstream and downstream line components from Syntegon enable efficient processes and a clear responsibility from a single source.
Benefits:
Energy demand & process time
- Reduction of CIP / SIP times by tilting of shelves as well as minimizing drying times and water consumption
- Laser welded shelves with less weight and thereby reduced energy consumption
- Optimized temperature distribution on the shelves for a stable process
Safety
- Optimized locking system for the doors ensures an extremely low leak rate and contributes to high process reliability
- Continuously variable height adjustment of the slot door opening to the height of the primary packaging to reduce the air exchange between the barrier system and the FD chamber
- Improved pressure vessel for an extended lifetime
- Comprehensively tested and modular software reduces errors and shortens validation times
- High quality standard components ensure global and quick availability
- Redundancies for undisturbed operation
Flexibility
- Flexible loading due to single or double inter-distance of the shelves, selectable in the software
- Freely adjustable stoppering pressure of the shelves
- Flexible recipe editor and simple troubleshooting through extensive monitoring in the software
- Optimal use of available space and short delivery time due to modular design
Usability
- Fully automated and compact filter integrity testing (WIT)
- Inline sieve in chamber drain to eliminate glass pieces or stoppers without entering chamber or condenser
- Optimized access to the ice condenser in vertical systems
Complete filling line from a single source
- Innovative and fully integrated loading system
- Optimized interfaces as well as unified documentation and components
- Quick and smooth project progress