The highly flexible standalone FCM 10-P freeze dryer from GEA has been designed for the production of small-scale batches and formulation/process development. Also available as a wall-mounted option, this two-chamber unit is configured to industry standards and equipped to measure in-process pressure increases. With a capacity of 10 kg and shelf space of 0.78 m², the FCM 10-P also benefits from easy-access doors and spare flanges for validation and/or additional equipment.
Using the same FALCO control system as the production unit, allowing direct and reproducible recipe transfer, the FCM 10-P is GLP/GMP-compliant and CIP-compatible. Available options include IQ/OQ documentation, wireless temperature sensors, VHP sterilisation and on-site engineering support.
|Capacity||0,78m² shelf area|
|10kg in in 24h|
|Possible Load||3.262 of 2R vials|
|1.694 of 6R vials|
|889 of 20R vials|
Designed to comply with the most stringent good manufacturing practice (GMP) standards, the new LYOVAC™ units have been built with operator safety in mind. Full isolator protection for processes involving potent or toxic substances is available. LYOVAC™ Freeze Dryers are a unique and efficient combination of proven technology and individual solutions that are customized to meet specific user requirements.
The lyophilizers are supplied with an integrated and exchangeable L-flange or a unique modular isolator system. 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, and liquid, powder or lyophilized form applications. Supplied in two sizes (1.5 and 4.5 m²) with nominal condenser capacities of 25 and 75 kg, the smaller FCM 25-I machine can process up to 6500 vials (2 mL), whereas the larger FCM 75-I capable of handling more than 20,000 similarly sized vials. Both manual and GEA’s Automatic Loading and Unloading Systems (ALUS™) system are available on request.
Each unit benefits from sterilisation by VHP VAPOVAC™ or steam, depending on the available utilities, and clean-in-place functionality. Further, ControLyo® nucleation on demand technology, wireless temperature sensors and LYOPLUS™ silicone oil detection can be provided. Alternative end-point detection is also available.
Fully compatible with toxic, potent and volatile product, the FCM units are ATEX-compliant and designed for easy scale-up. Partial loading is also possible for variable batch sizes.
For flexible product development and small-scale, semi-automatic processing, including the use of nests and tubs, the FCM range of LYOVAC™ Freeze Dryers from GEA provides reliable, safe and cost-effective productivity and price/performance excellence.
The following features are available with the system:
||1,5m² shelf area
||4,5m² shelf area
|25kg ice in 24h
||75kg ice in 24h
||6.523 of 2R vials
||20.039 of 2R vials
|3.388 of 6 R vials
||10.506 of 6R vials
|1.778 of 20R vials
||5.583 of 20R vials|
The VAPOVAC™ sterilizer uses VHP technology to sterilize equipment under vacuum. Only a very small quantity of hydrogen peroxide is used to penetrate the freeze dryer vessels and all associated piping of the equipment. This method effectively eliminates all residual contamination. The freeze dryer is then fully vented, leaving no harmful residues.
This process consists of three steps:
Low cost and kind to the environment
Very little energy is needed to operate the VAPOVAC™ sterilizer, making it cost efficient. H2O2-gas-sterilization does not release harmful carcinogenic or mutagenic by-products and therefore, is kinder to the environment. The chamber, condenser and connecting pipes are used at atmospheric pressure, which makes them less expensive and easier to install. The elimination of high-pressure hoses also makes the process safer and reduces operational wear – meaning that plant system life time is extended.
Increased plant availability
The faster turn-around results in greater efficiency. The H2O2-gas sterilisation process can be performed in approximately 3 hours for an average production freeze dryer depending on the freeze dryer options, compared with approximately 8 hours for steam sterilisation. This allows the plant operators to increase productivity and make the whole system more efficient.
The VAPOVAC™ system meets GAMP, cGMP, FDA, DIN, ISO and all other European and US codes. The residence time of the hydrogen peroxide can be varied as the system is monitored and can be adjusted to ensure effective sterilisation. After sterilisation, the hydrogen peroxide is completely and safely removed from the chamber – the operator having to positively confirm to the control system that H2O2 evacuation has been achieved successfully in order to complete the sterilisation process.
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