Ethylene oxide (EtO) gas sterilization is used across the pharma industry for a variety of products, including but not limited to medical devices. In light of FDA news release of January 2024, which encouraged end users to seek alternative sterilization to EtO, this panel discussion aims to explore viable alternatives to EtO, focusing on technologies capable of effectively replacing it.
The session will feature in-depth discussions on real-world case studies, examining the advantages and challenges of various sterilization processes based on the specific product types being treated. Particular attention will be given to the transition from EtO to saturated steam sterilization, with a special focus on the RTF (Ready-to-Fill) load configuration. Gerresheimer's partnership with Fedegari in developing an innovative sterilization approach will be showcased, alongside insights into VHP (Vaporized Hydrogen Peroxide) sterilization for medical devices.
Following the panel discussion, the attendees will have the opportunity to tour the Fedegari Tech Center, where they can observe the cGMP sterilizer used to support Gerresheimer's transition. This hands-on experience will provide valuable insight into the testing and validation strategies employed for RTF containers, and attendees will also explore VHP units as part of the broader conversation on alternative sterilization processes for medical devices.
The primary learning objective is to share how to practically transition from one sterilization process to another, and how to implement a rigorous and scientific study to support such a transition.
Food and beverages will be provided, compliments of Fedegari.
Please note: This event has a MAXIMUM capacity of 35 people - please register soon!
"Walk-ins" can NOT be accommodated for this program - advance registration is required.
Cancellation Policy: Full refund or credit voucher for a future program will be given up until 7-days before program; After June 11th, no refunds or credit vouchers will be provided.
Darren Beckett – Senior Training and R&D Manager – Fedegari Technologies, Inc.
Claudio Maestri – Senior Project Manager – Fedegari Technologies, Inc.
Ramses Cuevas - Global Head of Product Development - Gerresheimer Glass Inc.