One of the skills of SBA members is in matching the packaging types and materials to the medical device and to the sterilisation process.
In selecting materials for sterile barrier systems for medical devices many aspects need to be considered including the following:
Sterilization compatibility
Sterilization is a critical component in ensuring the safety and efficacy of medical devices, particularly those that require a sterile barrier system to maintain sterility until the point of use. Selecting the appropriate sterilization method is essential to achieving the desired microbial inactivation while maintaining the integrity of the packaging materials.
This document provides an overview of the compatibility of various packaging materials with commonly used sterilization methods, including ethylene oxide (EO), gamma radiation, electron beam (e-beam), and steam sterilization. Understanding the interactions between sterilization processes and packaging materials is crucial for manufacturers, healthcare providers, and regulatory bodies to ensure compliance with industry standards and best practices. By summarizing the effects of different sterilization modalities on a range of packaging materials, this guide serves as a valuable resource for decision-making in the medical device industry. It aims to support the selection of suitable materials that can withstand sterilization without compromising functionality, durability, or sterility maintenance. Sterilisation-compatibility-August-2017-1.pdfavautuu uuteen ikkunaan or click here for a complete overview of sterilisation processes and material compatibility.
