cGMP Lyophilizers and Lyophilization Systems

GEA Lyophil GmbH is a leading manufacturer of lyophilizers (freeze drying systems) to the pharmaceutical and biotechnology industries. The quality and reliability of the GEA Lyophil equipment and systems are unparalleled after more than 50 years of operation. The engineering excellence behind every Lyovac® lyophilizer (freeze dryer) ensures flexibility, compactness, and modularity. Proven experience in engineering and manufacturing as well as numerous developments and patents underline GEA Lyophil's technological leadership in lyophilization (freeze drying).

GEA Lyophil routinely utilizes restricted access barrier systems (RABS) and isolator technology in large lyophilizer production systems

Lyophilization is a key processing step in the production of many aseptic pharmaceutical and biotechnology products. During lyophilization water is removed from temperature sensitive or unstable product solutions and transformed to stable dry products with its original properties. This lyophilized product can be handled and stored easier under aseptic conditions.

GEA Lyophil GmbH range of products and services

cGMP lyophilization (freeze drying) systems to the pharmaceutical and biotechnology industries:

• Lyovac® GT 2 and GT 2 S - compact and versatile laboratory lyophilizer units
• Lyovac® FCM 10 to FCM 30 - pilot and small-scale production lyophilization plants
• AW 2 EUTECTIC MONITOR - Measuring system for product tests
• Cryomicroscope
• Lyovac® FCM 40 to FCM 600 (shelf area: 4 to 60 m2) - large-scale industrial production lyophilization plants built to customer specifications

Lyophilizer accessories and services:

• Fully automatic process control (Thermodynamic Lyophilization Control TLC®)
• Hydraulic stoppering device
• Clean In Place (CIP) cleaning system
• Steam In Place (SIP)
• Steam sterilization system (D version)
• Vaporized Hydrogen Peroxide (VHP) sterilization system
• LN2 cooling technology
• Automatic Loading and Unloading System (ALUS)
  • Batch loader / un-loader for bulk products in trays
  • Loader / un-loader for products in vials or ampoules without trays
  • Systems applying isolator and containment technology
• GMP sterilizers in all sizes for the sterilization of lyophilizers (freeze dryers) and isolators (as well as for other applications)
• Pure-steam generators
• Biological and chemical indicators for qualification and validation purposes
• Products and documentation to meet FDA regulations and in compliance with GLP, cGMP, and GAMP guidelines
• Engineering support for integrated solutions
• Qualification and validation support including IQ/OQ procedures

For information about our Atlas range (a.k.a. RAY™ and CONRAD™) of freeze dryers (lyophilizers) for food, beverage and other non cGMP freeze drying applications please access this page Freeze Dryers & Freeze Drying.

Download PDF: GEA Lyophil Freeze Dryers for the Pharmaceutical & Biotechnology Industries.

Detailed PDF brochure about the technology of lyophilization, the history of GEA Lyophil, the LYOVAC range of freeze dryers, and the Niro Inc. US distribution and service responsibilities.