LYOVAC® Freeze dryers for small scale production modules
For flexible product development and small-scale production, including the use of nests and tubs, the FCM-I range of LYOVAC® Freeze Dryers from GEA provides reliable, safe and cost-effective productivity and price/performance excellence.
Designed to comply with the most stringent good manufacturing practice (GMP) standards, the LYOVAC® FCM 25-I, FCM 75-I and FCM 150-I freeze dryers are a unique and efficient combination of proven technology and individual solutions that are customized to meet specific user requirements.
Integrated VarioSys® Isolator
Built with operator safety in mind, full isolator protection for processes involving potent or toxic substances is available, and each unit is supplied with an integrated L-flange for the modular isolator system VarioSys®.
Supplied in three sizes (1.5 m², 4.5 m² and 9.9 m²) with nominal condenser capacities of 25 kg, 75 kg and 150 kg, the smaller FCM 25-I machine can process up to 6500 vials (2 mL) per batch, whereas the larger FCM 75-I and FCM 150-I units are capable of handling more than 20,000 and 42,000 similarly sized vials, respectively. An automatic loading and unloading system (ALUS®) is available.
| FCM 25-I | FCM 75-I | FCM 150-I | |
|---|---|---|---|
| Capacity | |||
| Shelf area | 1.5 m² | 4.5 m² | 9.9 m² |
| Shelves | 5 | 5 | 7 |
| Kg ice/24 h | 25 kg | 75 kg | 150 kg |
| Possible Load | |||
| 2R vials | 6523 | 20,039 | 42,406 |
| 6R vials | 3388 | 10,506 | 22,295 |
| 20R vials | 1778 | 5583 | 11,900 |
VarioSys: Evonik Case Study
The LYOVAC® freeze dryer offer the following features and benefits:
- compact footprint with a belly condenser design
- suitable for Grade C environments
- LYOSPARK® controlled nucleation
- LYOPLUS® silicone oil detection
- Fast turnaround through defrost/CIP/SIP
- alternative end-point detection is also available.
Plus, fully compatible with toxic, potent and volatile products, the FCM units are ATEX-compliant and designed for easy scale-up. Partial loading is also possible for variable batch sizes.
Operating in a Grade C environment, other modules, such as filling and capping systems, can be quickly and easily interchanged, resulting in both a dramatic reduction in footprint and equipment costs.
Available for rapid delivery — with low infrastructure requirements — for multiple product and/or delivery device lines, the modules offer an ideal solution for vial, ampoule, syringe and cartridge processing, as well as liquid, powder or lyophilized form applications.
関連製品
LYOVAC® Pharma Freeze Dryer
GEA’s LYOVAC® industrial-scale freeze dryers are built to customer specifications and are available with production areas of 1–60 m² and condenser capacities of more than 1000 kg.
SMART LYO® Pharma Freeze Dryer
SMART LYO™ Freeze Dryers help reduce the cost of freeze drying while maintaining quality and performance, making validation and documentation easier and reducing delivery times.
Process Analytical Technology (PAT) for Lyophilization: LYOPLUS®
LYOPLUS™ mass spectrometer is a multi-purpose measurement device for pharmaceutical freeze dryers.
ALUS® Load & Unload of Lyophilizers
ALUS® Automatic Load & Unload Systems minimize the risk of operator/product contamination while loading and unloading a freeze dryer.
