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Guiding the transition: the future beyond EtO sterilization

EtO sterilization transition: Process-Driven strategies with vH₂O₂ and moist heat 

Process-first sterilization for complex medical devices

The transition from ethylene oxide (EtO) sterilization is redefining how heat-sensitive medical devices are sterilized. Material compatibility, device complexity and evolving regulatory expectations are making traditional approaches no longer sufficient.

Sterilization is no longer a technology choice.
It must be governed as a process.

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Our commitment: moist heat and vH₂O₂ as the safest and most efficient alternatives

At Fedegari, we support this transition through a process-driven approach based on two technologies:

  • Moist Heat, when material compatibility allows
  • Vaporized Hydrogen Peroxide (vH₂O₂), for heat- and moisture-sensitive devices

These are not alternatives by default, but they are selected and developed based on process requirements.

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What this enables

Enhanced safety for operators, patients and the environment


Cycle time reduction up to 80% compared to traditional methods


No post-process quarantine, thanks to controlled residuals


Full regulatory alignment (FDA, ISO, AAMI frameworks)


Product integrity preserved, even for complex geometries and multi-material devices


FEDEGARI TECH CENTERS

 Sterilization performance is not a property of the sterilant: it is the result of how the process is developed and controlled. 

Fedegari Tech Centers

are where sterilization processes are experimentally developed, tested and validated.
Here, we evaluate material behaviour, sterilant diffusion, residual levels and process parameters.

This enables the development of tailored sterilization cycles for complex devices, including multilayer packaging and multi-material assemblies.

The following table is not a theoretical dataset, but the result of real sterilization development activities on complex medical devices.

Fedegari has successfully addressed long and non-vented geometries, multilayer packaging systems and heterogeneous material combinations, achieving sterility assurance levels up to 10⁻⁶ (12 log reduction), with controlled residuals and full product integrity.

PRODUCT CLASS / DESCRIPTION MATERIALS
syringe Empty syringe MD, Class IIa PP, LDPE, PI, Medical-grade paper, PA/PE film
vitrectomy Vitrectomy system MD, Class III PC, Tyvek®, PP
suture Suture Kit MD, Class IIb PA, Tyvek®, PET
pfs-drug PFS with ophthalmic drug Combination Product Glass, PI, Tyvek®
rtuRTU vials Primary container – MD Class IIa Glass, Tyvek®/LDPE
heart Pacemaker MD, Class III Various materials
filter Filter Single Use Technology PES, PSU, PP, PU, PC
hemodialisys Hemodialysis Tubing set MD, Class IIb PVC, PP, Medical Paper/LDPE
oxygenator Oxygenator MD, Class III PU, PET, PVC, PC, Tyvek®/LDPE

Explore more

Download the White Paper and discover how sterilization processes are developed for complex medical devices.

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