Terminal Sterilization, Liquids
EN.1.1.1
SP
FOA and FOW - Series
PROCESSES
Sterilization of aqueous solutions in sealed containers (such as LVPs of different formats,
Sterilization vials, PFS, blister packs, etc.) share a well-known common
Washing problem: during the process they develop a pressure inside
the primary container higher than the pressure of saturated
Chemical
bio-decontamination steam at the same temperature. More critical than the
phenomenon itself are the consequences on the product
Contamination control
and/or the container itself.
Dense-phase fluids
Some of the most important features of these sterilizers
SPECIAL APPLICATIONS are related to the control of critical process parameters
designed to assure the highest flexibility in process control
Rotating sterilizers
to prevent any undesired deformation/damage of the
Pharmaceutical closures
processing containers, while providing the desired thermal treatment
to the product. Both types of sterilizers share the same
COMPONENTS design technology of all Fedegari machines and are capable
Pressure vessels of the highest performances and undisputed reliability.
Doors
Piping Steam-Air Mixture or Superheated Water?
Process controller The selection of either one is often critical and, though both are capable of the same general
Wireless sensors performances, the final choice is dictated by process needs downstream of sterilization
(does the load need to be dry? Does the container show any sign of hydration? How can
ACCESSORIES
the highest productivity be achieved? Are other loads to be sterilized through the same
Un/loading conveyors machine? etc.). Both types of machines are designed for operating with the new RTWS3
Customized racks wireless temperature sensors that, especially on the large automatically loaded models,
offer unrivalled ease of use and optimal process control. Both versions are offered in
capacities ranging from few hundred liters to a few tens of cubic metres, all guaranteed for
the same process performances.
DOC. 284544.2/15.07.2014 fedegari.com
Terminal Sterilization, Liquids
They can also be equipped with fully automatic un/loading conveyors for the highest
CONTACT US:
productivity with virtually no maintenance inside the sterilization chamber. Where the
product is liable to separation or for accelerating thermal transition phases the whole load
Italy can be rotated during the entire process.
Fedegari Autoclavi SpA
SS 235 km 8
27100 Albuzzano (PV) FOA Steam-Air Process
T +39 0382 434111
Magnetically driven fans force a high rate of fluid
F +39 0382 434150
E fedegari@fedegari.com circulation within the chamber. Internal sanitary
hollow plates add additional heating/cooling
capacity whilst minimizing condensate creation.
Steam and air are injected according to the
Germany control algorithms to finely control the process.
Fedegari GmbH
This system is the usual choice where terminally
Lehrer-Götz-Weg, 11
81825 Munich sterilized products are to be unloaded dry.
T +49 89 42044920
F +49 89 42044918
E info@de.fedegari.com FOW Superheated Water Process
Water is continuously circulated through the
system and sprayed over the load. Fine control
Singapore of heating and sterilization is achieved by
Fedegari Asia Pte. Ltd. superheating the water using modulated steam.
8, Boon Lay Way Load cooling is achieved by subsequent cooling of
#03-16 - Tradehub 21 the circulated water. Counter pressure control is as
609964 Singapore
per the steam-air mixture process. The process is ef-
T +65 6 3164761
F +65 6 8967365 ficient and faster than the FOA process. It is also an
E info@fedegariasia.com ideal process for <105 °C processing. Wet loads can
be overcome using on automated drying extension
with the installation of specific drying solutions
downstream of the sterilization chamber.
Switzerland
Fedegari (SUISSE) SA
Via alla Gerra, 11 Standards & Regulatory Compliance
6930 Bedano
T +41 91 9352090 Fedegari has always focused on the regulated pharmaceutical industry; compliance to the
F +41 91 9352099 following standards is not just 'achievable' but is our standard:
E info@fedegarisuisse.ch
• EN285 & 556 (where applicable)
• EN Directives and associated standards
• ISPE cGMP and GAMP5 compliant (GAMP including supplier pre-
USA validation)
Fedegari Technologies, Inc. • FDA CFR's including 21 CFR parts 210, 211 and 11
1228 Bethlehem Pike
• ISA, ISO and DIN (where required)
18960 Sellersville (PA)
T +1 215 4530400 • ASTM A240, 213, 270, SA312 for chamber and piping material
F +1 215 4530406 • ISO9001 & 13485 for overall manufacturing
E info@fedegariusa.com • All IMB, MHRA and associated regulations.
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