Applicable Standards
- ISO 11607
- ISTA
- USP
- ASTM
Services Summary
We offer a wide breadth of packaging experience to help our clients deliver safe and effective products to market. Our services encompass consulting, package validation, material qualification and package development.
Nelson Labs packaging solutions department has experience with successful validations encompassing multiple product, package and sterilization configurations throughout the medical and pharmaceutical industries. We use proven state-of-the-art technology to provide fast and accurate results.
Consulting
Our consulting team has decades of experience in establishing protocols, test plans and justifications. We are here to provide regulatory assistance before, during and after your regulatory submission. We can provide gap assessments between final product configuration and standard method discrepancies.
Packaging Validation
Nelson Labs offers complete package testing and services in compliance with global regulatory requirements. Full packaging validations and Protective Packaging, SBS Package Design, Packaging Specifications and Failure Analysis.
Material Qualifications
Our leading experts provide insight regarding material properties, strength, durability and performance for medical device and pharmaceutical packaging. They focus on providing tests that work toward package design and have the ability to adjust methods to customize testing. Services include Tensile Test, Tear Test, Puncture Test, Syringe Force, and Sutherland Rub Tests.
Packaging Qualifications
Our trained staff is available to help troubleshoot any packaging-related issues and conduct in-depth failure analysis. Services include Sample Size Justification, Test Plan (Acceptance Criteria, Test Method Justification, Protocol Development), Sealer Validation, Regulatory Assistance, and Gap Analysis.
If you have additional questions about packaging testing and qualification solutions, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.