In medical device sterilization, complexity begins when sterilization processes must interact with real product configurations.
• Multilayer packaging can limit sterilant diffusion and create gradients that affect both penetration and residual removal.
• Long lumens and non-vented geometries introduce constraints that make sterilant distribution dependent on process dynamics, not only on accessibility.
• Multi-material assemblies can respond differently to the same process conditions, influencing both sterilization efficacy and product integrity.
This is why sterilization performance cannot be considered a property of the sterilant alone. It is determined by how the process is developed, tested and controlled under specific application conditions. From syringes to oxygenators, from multilayer packaging to long lumen systems, sterilization challenges differ.
But the process must always be governed.
The following applications are not product examples. They represent sterilization process conditions across different levels of complexity, device classes, materials and packaging configurations.
Each configuration reflects a specific interaction between sterilant, materials and geometry, requiring dedicated process conditions.
| APPLICATION | CLASS / DESCRIPTION | MATERIALS |
|---|---|---|
| MD, Class IIa | PP, LDPE, PI, Medical-grade paper, PA/PE film | |
| MD, Class III | PC, Tyvek®, PP | |
| MD, Class IIb | PA, Tyvek®, PET | |
| Combination Product | Glass, PI, Tyvek® | |
| Primary container – MD Class IIa | Glass, Tyvek®/LDPE | |
| MD, Class III | Various materials | |
| Single Use Technology | PES, PSU, PP, PU, PC | |
| MD, Class IIb | PVC, PP, Medical Paper/LDPE | |
| MD, Class III | PU, PET, PVC, PC, Tyvek®/LDPE |
These applications include different device classes, materials and packaging conditions, from empty syringes and vitrectomy systems to hemodialysis tubing sets and oxygenators.
“Beyond Eto: mastering sterilization complexity in real medical device applications”
The case study on combination products sterilization shows how vH₂O₂ was investigated on glass prefilled syringes containing an ophthalmic drug product, enclosed within Tyvek®/plastic blister packaging.
The investigation focused on:
• material compatibility;
• penetration efficiency through secondary packaging;
• sterilization process effectiveness;
• H₂O₂ residues in the product and secondary packaging.
The device defines the challenge. The process defines the answer.
Download the full case studies to discover how these challenges are addressed through controlled process development.
The applications presented throughout this article show how complexity changes the way sterilization processes must be developed, verified and transferred to production.
Only under these conditions, the ability to experimentally develop and industrialize sterilization processes becomes the determining factor in achieving reliable and reproducible performance.