With 55 years of experience in the engineering and manufacturing of freeze dryers and over 1000 delivered installations and thousands of freeze drying tests carried out for the pharmaceutical and biotechnology industries underline GEA Lyophil’s technological leadership.
GEA Lyophil’s freeze dryer product line comprises laboratory freeze dryers, pilot plants for R&D purposes or small production batches, industrial size production freeze dryers as well as complete freeze dryer systems consisting of one or multiple freeze dryers plus
ALUS® (Automatic Loading and Unloading System) and isolators.
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.
The design and manufacture of freeze dryers and freeze drying systems is carried out in accordance with all cGMP, CE, GAMP and 21 CFR Part 11 guidelines.
SMART LYO™ is a new range of competitively-priced pharmaceutical freeze dryers
SMART LYO® freeze dryers are available in shelf sizes of 0.57 m˛ up to 20 m˛ with
a condenser capacity of up to 400kg.
Smart Features:
-
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.
-
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.
-
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.