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Medical Package Testing

Packaging design, validation and testing. Delivering superior packaging validation, testing, and design that minimizes costs while ensuring all regulatory requirements are satisfied.

Your Partner in Innovation

Life Science Outsourcing’s Medical Package Testing services offer a turnkey solution for medical and pharmaceutical start-ups as well as original equipment manufacturers. With more than two decades of experience, our manufacturing and engineering experts work as an extension of your team, turning ground-breaking concepts into commercial-ready products.

We are ISO 13485 certified and FDA-registered with 10,000 square feet of state-of-the-art Class 10,000/ISO 7-rated cleanroom space.

Services and Expertise

Our medical package testing experts in our ISTA-certified packaging test lab (ID Number ST-2339) are committed to ensuring a complete and comprehensive packaging solution that meets regulatory requirements and can withstand the rigors of shipping and distribution. Our testing and validation services are based on ISO 11607-1:2019 and adhere to FDA, ISO, EN, and CE Mark requirements. Each partnership includes an in-depth evaluation of the product and package with tailored protocols and rationale, detailed test results, and a comprehensive final report with regulatory considerations and next steps.

Package Design

From low-volume plastic packaging and low-cost tooling to high-volume plastic packaging needs, our primary to secondary packaging solutions ensure your product reaches its final destination safely and intact.

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Package Validation Testing

From visual inspection and peel strength tests to dye penetration, bubble emission, and burst tests, our package validation testing services ensure compliance with ISO 11607 and applicable ASTM standards.

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Distribution Simulation Testing

From drop, vibration, and compression testing to atmospheric conditioning, our distribution simulation testing exposes products and packaging to real-life hazards, ensuring compliance.

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Stability Testing

From real-time aging to accelerated aging, our stability testing services including our accelerated aging calculator help manufacturers determine shelf life and the effects of aging on materials.

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Standards

Life Science Outsourcing has in-depth experience in compliance with a wide range of standards related to medical package testing. Both the FDA and international regulatory bodies emphasize compliance with ISO 11607; Packaging for terminally sterilized medical devices. This standard defines the test requirements necessary to ensure that the terminally sterilized package/device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization, shelf life, transport, or storage.

Our experts and processes provide package testing services that comply with the following standards:

  • ANSI – American National Standards Institute
  • AAMI – Association for the Advancement of Medical Instrumentation
  • ASTM – American Society for Testing & Materials
  • ISO – International Organization for Standardization
  • ISTA – International Safe Transit Association

Frequently Asked Questions

We’re committed to helping medical device manufacturers find the answers and solutions they need to bring their innovations to life quickly and efficiently. Get answers to the most common questions for Cleaning & Decontamination and all our services.

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Let’s work together

Life Science Outsourcing prides itself on our role as partners in bringing medical innovations to life. That partnership forms the foundation of what sets us apart.