Support your product’s safety, sterility, & regulatory success
Whether you are preparing for U.S., EU, or global market submissions, your packaging system must demonstrate integrity, durability, and performance throughout its entire lifecycle, including distribution and long‑term storage.
Packaging validation must also be aligned with your sterilization validation. Sterilization methods such as gamma irradiation, ethylene oxide (EO), or steam can significantly affect packaging strength, seal integrity, and barrier properties. For that reason, validation is performed after sterilization, using the final packaging configuration—including IFUs, labels, inserts, and all other components—to demonstrate that the system consistently maintains sterility under real‑world conditions.
With expertise spanning both packaging and sterilization validation, Nelson Labs helps manufacturers plan and align testing strategies across development, validation, and lifecycle stages—reducing rework, avoiding misaligned studies, and generating high-quality data to support regulatory success.
Our teams in Salt Lake City, Utah and Wiesbaden, Germany support manufacturers worldwide in meeting the requirements of ANSI/AAMI/ISO 11607 Parts 1 and 2 and ISO/DTS 16775, delivering packaging validation programs aligned with the global standards regulators rely on.
Talk With A Packaging ExpertNelson Labs operates advanced packaging testing and validation laboratories in both the United States and Europe, enabling manufacturers to align testing strategies with regional regulatory expectations while maintaining consistency across global submissions.
A long-established center of excellence delivering routine monitoring, regulatory support for US FDA submissions, global product launches, and complex sterilization and packaging validations across both medical device and pharmaceutical packaging applications.
Recently expanded to meet growing demand for EU MDR-compliant packaging validation and testing, supporting manufacturers across Europe with local expertise and faster access to data.
Together, these sites provide coordinated global packaging solutions for emerging innovators through multinational manufacturers.
Nelson Labs supports packaging systems across development, validation, and post-market lifecycle stages. Our packaging testing solutions encompass consulting, package validation, material qualification, and failure analysis to integrate seamlessly with your broader product development and regulatory strategy. Our teams bring decades of experience validating packaging systems across a wide range of products, materials, and sterilization modalities.
Our packaging experts work alongside your engineering, quality, and regulatory teams to develop clear, standards-aligned strategies that support regulatory confidence.
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Nelson Labs delivers complete packaging validation services in compliance with global regulatory requirements, supporting both US and EU submissions.
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Our material qualification experts evaluate the physical properties, durability, and performance of packaging materials to support robust package design and validation.
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When packaging challenges arise, our teams provide structured troubleshooting and data-driven root cause analysis.
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Offering your team a full suite of packaging test services to support packaging integrity, shelf life, and distribution performance:
Manufacturers who partner with experienced packaging experts can:
Reduce risk of regulatory delays & deficiencies
Strengthen sterility assurance claims
Support global submissions with consistent data
Identify packaging risks before they become field issues
Accelerate time to market with streamlined strategies
Nelson Labs combines deep packaging science, regulatory insight, and global laboratory infrastructure to help manufacturers validate packaging systems with confidence.
From Salt Lake City to Wiesbaden and beyond, our teams are ready to support your packaging challenges at every stage of the product lifecycle.
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