A washer-sterilizer integrated with RABS and bio-decontamination MAL with H2O2 applied to the filling isolator. The washer-sterilizer unloads on module 1 of the RABS. Module 1: Washing/sterilization Module 2: Washed kegs unloading station Module 3: Empty kegs buffer station Module 4: Manual powder dosing, capping and bagging with automatic pneumatic lifting device. Packaging materials and tools are introduced through the H2O2 MAL connected to the module. Module 5: Filled and packed kegs unloading station Significant time and cost-savings through sequential workflow inside a gloved isolator. Learn more at fedegari.com

1. Fedegari Washer-sterilizer
Integrated with RABS and
Decontamination Material Air-lock
Integrated Solution for Sterile
Antibiotic Powder Filling of Al- kegs
Latest
developments

2. A washer- sterilizer integrated
with RABS and surface bio-decontamination
MAL with H2O2 applied to the RABS.
The washer unloads on module 2 of the RABS.
Module 1: Washing/sterilization
Module 2: Washed kegs unloading station
Module 3: Empty kegs buffer station
Module 4: Manual powder dosing, capping and bagging with automatic pneumatic lifting device.
Packaging materials and tools are introduced through the H2O2 MAL connected to the module.
Module 5: Filled and packed kegs unloading station
Kegs &
stoppers
washing
RABS
H2O2
MAL
(FCDV)
Unloading
station
Loading
station
Loading
station
Unloading
station
2
3 4
5
Integrated
solution 1
2
3 4
1
5

3. Capping and
bagging using
the automatic
pneumatic
lifting column
H2O2 MAL
Integrated Solution for Sterile
Antibiotic Powder Filling of Al- kegs

4. WHAT SETS
US APART?

5. What sets us apart?
through sequential
workflow inside
the RABS.
Ergonomic design
Unloading system works at the same level
from the washer to the RABS.
We offer unconventional
engineered solutions
that you cannot find on the market,
based on our pharma process
know-how and experience.
Total control of technology
We design and manufacture all critical components
and sub-systems in-house because nobody else reaches
the highest performances and reliability
with commercial components.
UNCONVENTIONAL APPROACH
This allows us to offer a totally
customized 360° solution
aiming to achieve the highest
cost-effectiveness and the
best performances.
Significant
time and
cost-savings

6. Built-in H2O2
vaporizer (FHPV)
designed and
developed
by Fedegari.
What sets us apart?
Cost-effectiveness
Time and cost-savings on
training and maintenance
due to standardization of
components, procedures and
process controller.
Fixed concentration profile
with no impact of H2O2
degradation on the process.
Significantly reduced costs
with non-proprietary consumables.
100% air tight
Inflatable gaskets
on bio-decontamination unit
and washer doors.
Thema4 process controller
Easy integration with other Fedegari
machines and SCADA systems.
Highly
customized
solutions
Fully modular &
custom-made
loading racks.
UNCONVENTIONAL TECHNICAL SOLUTIONS

7. Designed by Fedegari using over 60 years
of specific process know-how, Thema4 offers:
• Pre-validation with GAMP5 compliance, 21 CFR Part 11
• Online concentration monitoring
• Open system architecture
• Advanced control, monitoring and reporting functions,
also including parametric release options
• Complete integration with SCADA system
• COTS hardware
• Pre-validation that ensures minimal project risk and
lower customer effort required during equipment
qualification
Thema4
One process controller
for all the machines
manufactured by
Fedegari.

8. fedegari.com
Your solution provider.
Fedegari has progressively developed toward a “solution provider” position capable of
integrating different machines and processes for proposing high-performance and cost-
effective solutions for the bio-pharmaceutical industry.