Fedegari Washer-sterilizerIntegrated with RABS and

Decontamination Material Air-lock

Integrated Solution for Sterile Antibiotic Powder Filling of Al- kegs

Latest developments

A washer- sterilizer integrated with RABS and surface bio-decontaminationMAL 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 stationModule 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 & stopperswashing RABS

H2O2MAL

(FCDV)

Unloadingstation

Loading station

Loading station

Unloading station

2

3 4

5

Integrated solution

1

2

3 4

1

5

Capping and bagging using the automatic

pneumatic lifting column

H2O2 MAL

Integrated Solution for Sterile Antibiotic Powder Filling of Al- kegs

WHAT SETS US APART?

What sets us apart?

through sequential workflow inside the RABS.

Ergonomic designUnloading system works at the same level

from the washer to the RABS.

We offer unconventionalengineered solutions

that you cannot find on the market,based on our pharma process

know-how and experience.

Total control of technologyWe 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

Built-in H2O2vaporizer (FHPV)

designed anddeveloped

by Fedegari.

What sets us apart?

Cost-effectivenessTime and cost-savings on training and maintenance due to standardization of components, procedures and process controller.

Fixed concentration profilewith no impact of H2O2

degradation on the process.

Significantly reduced costs with non-proprietary consumables.

100% air tight

Inflatable gasketson bio-decontamination unit

and washer doors.

Thema4 process controllerEasy integration with other Fedegari machines and SCADA systems.

Highly customizedsolutions

Fully modular & custom-madeloading racks.

UNCONVENTIONAL TECHNICAL SOLUTIONS

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 andlower customer effort required during equipment qualification

Thema4One process controller

for all the machines manufactured by

Fedegari.

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.