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Combined washing
and sterilization

In high-potent manufacturing, isolator-based aseptic processing and space-constrained facilities, contamination control extends beyond removing residues from components. Materials often need to move between classified environments while preserving the conditions required for safe transfer.

The challenge is that contamination removal does not restore the sterile boundary. Before components can be transferred, contamination must be removed and transfer integrity re-established through a governed process.

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REMOVING CONTAMINATION IS EXPECTED. RESTORING TRANSFER INTEGRITY AFTERWARDS DETERMINES WHETHER THE PROCESS CAN CONTINUE SAFELY.

Fedegari governs contamination removal and sterile boundary restoration as a single contamination-control process.

By integrating washing, drying, sterilization and transfer preparation within one controlled environment, critical contamination-control decisions can be executed without moving loads between separate technologies or classified areas.

The result is restored transfer integrity, minimized contamination exposure and lower facility complexity.

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CONTROLLED TRANSFER PREPARATION

Washing, drying, sterilization and transfer preparation are executed as a continuous process sequence within the same controlled environment.

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MINIMIZED OPERATOR EXPOSURE

Contaminated components remain contained until decontamination, drying and sterilization have been completed.

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REDUCED FACILITY COMPLEXITY

The same controlled environment reduces the infrastructure, validation and maintenance requirements associated with separate technologies.

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REDUCED DRYING TIME

The pressure vessel is used to perform vacuum-assisted drying after washing, accelerating moisture removal by up to 30%.

PRESSURE CONTROL
In saturated steam sterilization, pressure governs steam conditions. Controlling pressure supports temperature uniformity and repeatable process behavior. 
±0.5°C UNIFORMITY
Temperature standard deviation is a key indicator of process behavior. The tighter the deviation, the greater the stability and repeatability across the entire load. 
DRY-LOADS
Critical components 
emerge sterile, dry and ready for immediate use. 
CANISTER PROVEN
We support advanced  canister-based transfer strategies while preserving filter integrity, drying performance and sterile transfer conditions.

DEDICATED PROCESS CONTROL FUNCTIONS

Fedegari's process control architecture governs contamination removal, drying, sterilization and transfer preparation through dedicated monitoring and recording functions.

Key process functions include:

  • Washing phase management
  • Vacuum-assisted drying control
  • Sterilization phase control
  • Continuous recording of temperatures, pressures, alarms and process transitions

Together, these functions provide documented evidence that each contamination-control objective has been achieved according to predefined process conditions.

Proven by numbers

PROVEN BY NUMBERS

30%
faster drying

50%
layout impact reduction

1
process sequence

- 40%
capex reduction

WHEN SHOULD YOU CHOOSE OUR TECHNOLOGY

HIGH-POTENT EXIT FLOWS

Where contaminated components must leave a classified environment and contamination spread must be controlled.

DIRECT GRADE A TRANSFER

Where components must move toward isolators or Grade A environments without intermediate handling or sterile barrier preparation.

FACILITY OPTIMIZATION

Where limited space, low throughput or facility constraints make separate contamination-control technologies difficult to justify.


FREQUENTLY ASKED QUESTIONS

Why is contamination removal not sufficient for safe transfer?

Because removing contamination does not automatically restore the sterile boundary required for movement between classified environments.

Why is this approach particularly relevant for high-potent manufacturing?

It helps contain contamination until transfer conditions have been restored, minimizing contamination spread beyond the originating environment.

 

Can components be transferred directly toward aseptic processing?

Yes. The process supports transfer pathways toward isolators and Grade A environments while maintaining contamination-control objectives.

 

How is operator exposure minimized?

Contaminated components remain within a governed process sequence until contamination removal and sterile boundary restoration have been completed.

Why is drying integrated into the process?

Drying is part of transfer preparation. Integrating it into the contamination-control sequence reduces process complexity and preparation time.

When is this technology most valuable?

When contamination control, sterile transfer requirements and facility constraints must be managed within the same workflow.

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