LYOVAC® Freeze Dryers
Production Plants (Industrial freeze dryers)

Large scale production plants built to customer specifications The LYOVAC® Freeze Dryer is the ultimate pharmaceutical Lyophilizer from GEA Lyophil that allows users the flexibility to design their machines for their individual manufacturing requirements. Every pharmaceutical plant and system from GEA Lyophil is a unique and efficient combination of proven technology and individual solutions reflecting the customer’s needs. Based on standard components, the company supplies plants for cGMP production configured to meet the customer’s specific requirements.

Shelf sizes: 8 - 55 m²

GEA Lyophil production Freeze Dryers are either non sterilisable units or steam respectively VHP sterilisable units.

Features of the LYOVAC® Freeze Dryer include:

• Choice of configurations, e.g. monoblock, 2-floor configurations.
• Various door configurations, including re-cooling, slot doors and many more.
• Reciprocating and screw compressors systems as well as LN2 cooling systems.
• Automatic CIP (Clean-in-Place) and SIP (Sterilisation-in Place) systems offer product protection, prevent contamination and increase the productivity by allowing a reduction in the number of staff needed to operate the equipment.
• AutomaticWIT (Water Intrusion Test) of the venting filters ensures integrity and increases the availability of the unit.
• Monitored stainless steel stoppering bellow.
• Proven vacuum pump system technology.
• VAPOVAC™ H2O2 Gas Sterilizer: a cost saving and environmentally friendly alternative to steam sterilisation.
• SCADA system for controlling and monitoring of reproducible and documented processes, meeting 21 CFR Part 11 regulation.

SMART LYO® Freeze Dryers
from table-top to production scale

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.

The new SMART LYO® pharmaceutical lyophilizers are made from proven standardised modules to keep costs down and quality up. They are available in a variety of sizes for most applications so that every customer can have exactly the plant they need and when they need it. Using already proven technology shortens delivery time and validation periods, and enables customers to bring their products to market more quickly.

Shelf sizes 0.2 - 40m²

SMART LYO™ range:

Bench Top Freeze Dryer SL2
The SMART LYO® Freeze Dryer SL 2 is designed as a bench top unit that has an available charging surface of 0.2 m². The ice condenser has a nominal ice capacity of > 4.
The drying chamber is a rectangular vessel, made of AISI304L stainless steel with a size of the 350 × 300 × 500 mm / 13.8 x 11.8 x 19.7 “ (W×D×H)

SMART LYO® SL 10 - 80
for Research and Development
These small-scale lyophilizers are available in shelf size of 0.4 - 8 m².

Ideal to prove and scale-up for GEA Lyophil’s larger industrial-size freeze dryers, and complete freeze dryer systems.

SMART LYO® Production Scale Freeze Dryers SL 100 - SL 600
The entire system is constructed on a single-floor plant frame for fast, simple commissioning. The system includes: the compact chamber/condenser unit, all system modules (hydraulics, venting system, vacuum) and available options such as CIP and SIP, interfacing to ALUS® (Automatic Load/Unload System)

SMART LYO® freeze dryers are available with a range of SMART features and options.:

• It is possible for the refrigeration unit to be installed remotely from the plant frame, even on a different floor if necessary. This allows the installation to be adapted as required to fit the customer’s infrastructure.
• The electrical cabinet can be positioned conveniently within the freeze dryer plant or centrally in a control room.
• Frame mounting allows SMART LYO® freeze dryers to be installed within the existing building architecture, i.e. the machinery room and the sterile area. This means that installation and assembly is very simple requiring just the connection of the plant to the unit frame and the switch cabinet.
• The GEA Lyophil Global Service Network provides rapid availability of original manufacturers’ spare parts worldwide, with comprehensive service and repair to minimise downtime and keep costs under control.
• Comprehensive documentation explaining both the operation and maintenance of the freeze dryer plant.
• H2O2 sterilisation with VAPOVAC™ steriliser.
• CIP system for cleaning the chamber and condenser.
• SIP system for steam sterilisation of the plant including all the necessary instruments and components as well as the upgrading of the chamber and condenser to one pressure vessel.
• Interfacing to GEA ALUS® (Automatic Load/Unload System), including slot door, constant level loading, etc.
• Re-cooling of the freeze-drying chamber including the door, constructed as a jacket for effective and rapid re-cooling of the plant following steam sterilisation.
• FAT (Factory Acceptance Tests) to demonstrate the conformance of installation and key performance of the equipment with the specifications.
• A standardised IQ/OQ package allows rapid validation of the plant.

Automatic Loading and Unloading Systems
ALUS® for Pharmaceutical Freeze Dryers

ALUS® Automatic Loading and Unloading Systems minimize the risk of contamination through human intervention in the loading and unloading of the freeze dryer. The amount of product processed by the use of automated loading and unloading processes is increased as the time taken for loading/unloading is much shorter compared to manual loading. Operational costs are reduced as state-of-the-art monitoring systems reduce the number of operators needed to administer the freeze drying process.

GEA Lyophil have the longest experience in the industry, so customers can be assured that each and every system will work reliably for many years to come.

ALUS® as retrofit option
The ALUS® Automatic Loading and Unloading Systems are also available as retrofit option in many existing applications, allowing a new lease of life for the plant for many more years of reliable and safe operation.

Isolator Technology and RABs
One step further in contamination prevention leads the use of ALUS® in connection with Isolator technology or RABs, whichever is most appropriate in each case.

ALUS® - efficient, safe and reliable performance with the following key features:

• High throughput, with loading speed of up to 400 vials per minute and unloading speed of up to 700 vials per minute
• High flexibility for different vial formats
• High levels of safety of operation and stability for all vial formats, even small ones with a diameter/height ratio of <3
• Quality sanitary design, with rounded corners for easier cleaning
• Excellent integration of ALUS® and the freeze dryer
• Patented design allows for a smooth transition of vials from ALUS® to Freeze Dryer
• Improved safety as no moving parts above open vials
• Frameless operation
• Design complies to zone concept: no machine drives in vial processing area
• Constant Laminar Air Flow (LAF) when using a transfer cart: the LAF unit moves towards the freeze dryer and covers the vials during the loading process.

ALUS® advantages:

• 100% utilization of the charging area and of the plant capacity
• Lyophilizers (freeze dryers) can be validated and meet GMP guidelines and Class 100 sterility requirements
• High availability through high quality construction of the fully automatic product handling system
• Greatly reduced risk of product contamination by reducing the clean room personnel down to one operator
• Cost reduction by using isolator and containment technology (reduction of costly clean room area).
• Sterilization of the system with VHP (Vaporized Hydrogen Peroxide).