Industrial scale production freeze dryers built to customer
specifications
Shelf sizes including 8-58m²
Product Know-How
For more than half a century GEA Lyophil
has designed and manufactured freeze dryers / Lyophilizers for the pharma and
biotech industries. GEA Lyophil is able to support its customers in the
installation and operation of a reliable, validated lyophilization process for
pharmaceuticals and biologicals.
Customized
plants
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.
Proven modules built together offer the possibility of choosing either a
cost-effective or a highly customized system. Each module and system component
must meet the strictest requirements and regulatory standards around the world.
Tailored Plant Configurations
2-floor installation: drying chamber upper level, condenser below
The choice of
a freeze dryer is driven by a variety of different requirements with regard to
meeting the needs of manufacturing and space. GEA Lyophil offers different
plant configurations such as single or two-floor installation when choosing the
GT concept. The compact modular FCM construction with its small footprint is
ideal for limited space on a single level.
FCM Concept (left), GT Concept (right)
Integration into a pharmaceutical production line may determine whether the
freeze dryer will be loaded and unloaded at the same side, or loaded at one
side and unloaded at the opposite side. Different door configurations like
full-sized door, slot door or door-in-door fulfill the industry’s needs in
every respect.
Proven Technology
GEA Lyophil’s freeze dryers are
equipped with safe and reliable components like reciprocating or screw
compressors or LN2 cooling systems, the highly effective and proven vacuum pump
system, the monitored stainless steel stoppering bellow. The SCADA system for
controlling and monitoring of reproducible and documented processes meets the
21 CFR Part 11 regulation.
Features of the pharmaceutical product
For many
customers it is vital to minimize contamination risks, both product as well as
the operators have to be protected. In this case a production system including
Freeze Dryer, ALUS® and isolators is the right choice.
Contamination prevention
There are numerous
cleanliness and safety systems on offer; GEA Lyophil can supply product
protection systems including automatic CIP (Clean-in-Place) and SIP
(Sterilization-in Place) systems. These prevent contamination and increase the
productivity by allowing a reduction in the number of staff needed to operate
the equipment. Further, automatic WIT (Water Intrusion Test) of the venting
filters ensures integrity and increases the availability of the unit. In
addition to this, GEA Lyophil’s new H2O2 Technology for freeze dryers is a
vital and cost-saving environmentally friendly alternative to steam
sterilization.