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FAQs – GEA Freeze Dryer Equipment

How is the lyophilizer integrated into this concept of interchangeable modules using the L-Flange Technology?  

The lyophilizer chamber/condenser is uniquely designed with a small footprint and is completely enclosed with a smooth and cleanable stainless steel skin. Because of the stainless steel skin, the chamber/condenser is cleanable and can be mounted in the Class C cleanroom.  The lyophilizer ALUS™ (Automatic Load/Unload System) is mounted within the PSI-l isolator using the L-Flange connection.  This Grade C ballroom design allows modular equipment on either side of the lyophilizer to easily be exchanged into and out of the PSI-L isolators with no interference from the lyophilizer. Since the lyophilizer is located within the clean room, there is full 360° access around the production line in the Grade C cleanroom. The refrigeration skid, vacuum skid, control cabinet and other support equipment are remotely mounted in the unclassified mechanical space either on a mezzanine or behind the wall of the cleanroom. The user has the option of locating the SCADA system in the cleanroom or within the mechanical space.  

Can component tubs or liquid filled vials be transported through the ALUS system?
Yes. When the ALUS™ is not used to load or unload the lyophilizer, transportation of tubs or liquid filled vials through the PSI-L isolator is easily accomplished. The conveyor belt and associated tooling are quickly configured to allow tubs of syringes to pass through the isolator. Vials that have been liquid filled and stoppered also may transport through the ALUS™ system and into the aluminum seal crimping module. Liquid filled vials and component tubs can be transported through the ALUS™ isolator while the lyophilizer cycle is in process or during other lyophilizer preparation activities.     

What kind of freeze dryers are available from GEA?
The LYOVAC™ state-of-the-art lyophilizers and ALUS™ Automatic Loading and Unloading Systems have been specifically developed to fit into the VarioSys® concept.  GEA can deliver standard sizes for the VarioSys® of 4.5 m² or 11 m² of usable shelf area. These smaller systems are built to comply with cGMPs and meet the same exacting standards as the larger production equipment offered by GEA.  Shelf and chamber capacity is as follows:
   


I see that GEA is the preferred Lyophilizer. Is this sterilized as part of the system or separate? If separate, what is the sterilization cycle?
The ALUS™ system and fascia of the lyophilizer are sealed within a PSI-L isolator and are VHP compatible. The standard VHP decontamination cycle for the PSI-L isolators developed by SKAN can be used for the ALUS™. The lyophilizer chamber/condenser is designed for 1.7barg @ 130°C and may be sterilized by a traditional steam sterilization cycle of 30 minutes at ≥121°C.  
   
Can the lyophilizer and ALUS equipment be added at a later time to the VarioSys® production line? 
Yes, with some planning during the preliminary design of the VarioSys line and facility.  GEA will provide equipment drawings and utility tables for a successful future installation. 

Can a quicker time to market be achieved on this kind of equipment versus the large, high-speed industrial lines?

Yes. The delivery, documentation and qualification times can be shorted due to the standardization of the equipment. The standard design also leads to lower investment costs when compared to conventional, customized lines.    

Are the same features available on these small lyophilizers as the large industrial size lyophilizers?  Can scale up be accomplished in an efficient manner?
Yes. These smaller lyophilizers can be used for clinical scale and small batch commercial manufacturing. If the product requires increased batch sizes in the future, scale up to the GEA industrial lyophilizers is easily accomplished.  For example, the same FALCO (Fully Automated Lyophilizer Control and Operating System) SCADA system is available on any size GEA lyophilizer. The lyophilizer cycle, controls, shelf design, refrigeration performance, other critical performance features are scalable to the large industrial size dryers.  

Are there PAT options available on these smaller scale lyophilizers?
Yes. Virtually all PAT options available on the industrial size lyophilizers are available on these VarioSys® models. This includes, for example, the LYOPLUS™ and LYOSPARK™ technologies. LYOPLUS™ is a mass spectrometer based technology that can detect minute amounts of silicone oil within the chamber/condenser. The LYOPLUS™ can also support the basics of lyophilizer cycle optimization and leak detection. LYOSPARK™ is GEA’s controlled nucleation technology which can reduce cycle times up to 30% and improve the crystalline structure of the product.  

Are there any features specific to the GEA lyophilizer to support the freeze drying of potent products?
Yes. Options are available for potent product processing with the lyophilizer. Some of these options include: (1) a filtration system between the condenser and vacuum pumps which prevent accidental release of potent particles through the vacuum system, (2) optional vacuum pump flushing in the event of filter failure, (3) options for CIP recirculation and special draining, (4) spray wands within the PSI-L isolator for wash down of the ALUS™, etc.

How much experience does GEA have with row-by-row loading systems like the one used in the VarioSys® production line?
GEA is one of the most experienced manufactures of systems like this in the world.  In 1989 GEA installed its first ALUS™ system.  In 1997, the first isolator contained ALUS™ went into operation.  Today there are more than 250 GEA ALUS™ installed systems worldwide.