Explore the Newest Best Practices for Sterile Barrier Systems, Packaging Design, and Regulatory Compliance
Life Science Outsourcing (LSO) is excited to announce the release of the updated 2025 edition of our comprehensive white paper, “Medical Device Packaging: Mastery of Design, Sterile Defense, and Compliance.” This revised guide reflects the latest advancements in medical package testing and the growing regulatory landscape surrounding sterile packaging.
Whether you’re preparing for packaging validation, reassessing your sterile barrier systems, or navigating global compliance requirements, this resource delivers critical insights to help you succeed.
What’s New in the 2025 Edition?
This white paper has been carefully revised to reflect current trends, updated standards, and best practices, including:
- Enhanced coverage of ISO 11607-1:2019 and ISO 11607-2:2019, with deeper integration of risk management and usability testing
- The latest guidance on ASTM sterile barrier testing methods, including seal strength, dye penetration, and bubble emission tests
- Emphasis on real-time aging studies in light of changing regulatory expectations
- Exploration of emerging sterilization methods and what they mean for material compatibility
Why It Matters
Medical device packaging is more than a protective shell—it’s a critical component of product safety, regulatory compliance, and patient outcomes. With regulatory agencies worldwide increasing scrutiny, ensuring packaging systems are robust, validated, and sustainable has never been more important.
Who Should Read This
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Quality and regulatory professionals in charge of package validation
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Packaging engineers developing sterile barrier systems
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Project managers preparing for FDA or EU MDR submissions
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OEM teams looking to streamline time to market while reducing risk
Download White Paper
Need help putting these insights into practice?
Contact our experts to learn how our ISO 11607-compliant medical package testing services can support your next product launch.
