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 for the pharmaceutical and biotech industry. 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
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.
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.
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.
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.