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.
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Смежные продукты
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.
Аналитика GEA
The breakthrough that changed spray drying
In 1976, NIRO engineers responded to a competitive challenge by rethinking what spray drying could do. Their idea became the multi-stage dryer MSD. Fifty years later, the same fundamental principle helps turn liquids into the powders used in essential nutrition products and important medicines around the world. Refined through decades of engineering expertise, customer insight and continuous development, MSD is a story of innovation with lasting impact.
Не только оборудование: повышение эффективности работы предприятия
Эффективное оборудование не является автоматической гарантией эффективности всего предприятия. Реальные улучшения часто начинаются с того, что мы перестаем ограничиваться рассмотрением отдельных единиц оборудования и начинаем вникать в то, как технологические процессы, энергетические системы и эксплуатационные решения влияют друг на друга. Этот комплексный подход позволяет выявить возможности, которые в противном случае могли бы остаться незамеченными.
Как клапан меняет подход к производству продуктов питания и напитков
На предприятиях по производству продуктов питания и напитков клапаны, как правило, приводятся в действие с помощью сжатого воздуха. GEA Hydract® Actuation Technology обеспечивает привод клапанов с помощью воды в замкнутом контуре с цифровым управлением. Результатом стал клапан, который можно точно зафиксировать в нужном положении и регулировать с высокой точностью. Это обеспечивает снижение энергопотребления и повышение уровня контроля.
