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.
Large scale production plants built to customer
specifications
Shelf Size 8 - 58
m2
GEA Lyophil production Freeze Dryers are either non
sterilisable units or steam respectively VHP sterilisable units.
Automation and highest contamination
prevention.
The handling of pharmaceutical substances such as cytostatics
creates a high need for operator and product protection. A typical Freeze Dryer Production System
incorporates the following components:
-
Multiple Freeze Dryers
-
-
Common CIP-Skid
-
-
SCADA System
Pilot Plants
For R & D and Small Scale
Production
Shelf Size 0.4 - 8 m2
Lab Units
For Laboratories, Universities and Research
Institutes
Shelf Size 0.1 - 0.3 m2
Features of the freeze dryers
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
-
VHP Technology: 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
More
information about Freeze Dryers (Lyophilizers):
Sterilization of Freeze
Dryers | Retrofit | Loading/Unloading of Freeze Dryers | ALUS®
Lyophilization Application
Testing |
More about GEA
Lyophil | Contact details of GEA Lyophil
Downloads
Gefriertrockner und Automatische
Beladesysteme | Automatische Be- und Entladesysteme
Mehr als 50 Jahre Erfahrung im Design und der Herstellung von
Gefriertrocknern für die Pharma – und Biotechindustrie beweisen GEA Lyophils
technologische Führerschaft. GEA Lyophil liefert Laborgefriertrockner,
Pilotgefriertrockner für die Entwicklung und kleine Produktionsmengen,
Produktionsgefriertrockner im Industriemaßstab sowie vollständige
Produktionssysteme mit einem oder mehreren Gefriertrocknern, automatischem Be-
und Entladesystem (ALUS®) sowie Isolatoren ... weiter lesen