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Beyond Eto: mastering sterilization complexity in real medical device applications

The industry is moving past Ethylene Oxide. But how do you make safer alternatives actually work when they meet real-world medical devices?

 Watch Fedegari’s webinar recording and explore how a process-driven approach is the key to engineering the transition to safer processes for your medical devices.

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With Claudio Maestri, Product Manager Fedegari and Lucia Maita, Training & Process Development Expert Fedegari

Did you miss the webinar of June 3rd or were you unable to attend? Don't worry, you can find the full recording below.

The paradigm is changing

The shift away from EtO is an urgent industry priority. However, adopting a new sterilization modality isn't always straightforward. When dealing with the real-world complexity of medical devices, equipment alone is not enough.

When complexity increases, process knowledge makes the difference.

At Fedegari, sterilization feasibility starts from the device. Every medical device asks a different process question: material composition, intricate geometries, packaging configurations and multilayer structures requiring sterilant penetration without residual accumulation all contribute to defining the process.  

These conditions become particularly evident in applications involving: 

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

Complexity proves expertise
We do not treat complexity as an obstacle. We treat it as the territory where our true process knowledge becomes measurable.
This webinar is designed to support professionals dealing with the challenges of medical device sterilization:

  • Multilayer packaging: where the sterilant must penetrate multiple barriers and be removed without leaving critical residuals.
  • Long lumens & non-ventilated geometries: where the distribution of the sterilant relies entirely on the dynamic behavior of the process.

 

  • Multi-material assemblies: where different materials react differently under the exact same conditions. 
  • High-risk classes: where clinical risk drives the demand for absolute sterility and robust process validation

When dealing with complex medical devices, finding the right sterilization method requires the ability to design, test and validate robust processes. This is exactly how we support our partners and clients in our Tech Centers: working side-by-side to translate alternative sterilization modalities into validated industrial processes. 

The device is the challenge. The process is the answer.

Join Claudio Maestri and Lucia Maita to explore real-world case studies applying vH₂O₂ sterilization to diverse medical devices. They will guide you through our proven operational framework, tackling process complexities head-on:



  • Discover how materials, geometries and packaging influence sterilization feasibility
  • Learn sterilant diffusion, residuals, and worst-case conditions
  • Innovate by developing customized cycles
  • Impact the process with measurable results

Complete the form to watch the webinar recording