3 Testing Tips for Medical Device Packaging

Sterile medical device package testing produces the data necessary for compliance with ISO 11607, Packaging for Terminally Sterilized Medical Devices, Part 1: Requirements for materials, sterile barrier systems and packaging systems and Part 2: Validation requirements for forming, sealing and assembly processes.

Karen K. Greene

Here are some key tips for ensuring that your medical package system is evaluated and ultimately validated with the most appropriate, relevant testing protocols for validation of sterile barrier integrity and overall package and product safety and efficacy.


Define the testing objectives and required testing outcomes
Is the testing exploratory or design feasibility testing? Define what you want to learn. Be honest about what is known about the performance of your package design. Ask yourself if the packaging system is ready for prime time.

Is the testing considered validation for a regulatory submission and compliance for the relevant industry standard(s)? This requires expertise in interpreting compliance to the standard(s).

Take the time to review and interpret the relevant industry packaging standards (such as ISO 11607 Parts 1 and 2 and the AAMI Technical Information Report TIR 22). Seek guidance and expertise before you conduct your testing.

Determine the value proposition for insourcing vs. outsourcing the testing activities
Review your internal test capabilities, and compare them with the project goals. Is the appropriate test equipment available in-house? Do you have the expertise to run the test equipment correctly? What is the lead time and availability of equipment and staff to meet the project timeline?

Evaluate the available external providers. Make sure any outsourced testing provider has the appropriate depth of expertise.

Also, evaluate the testing lab's industry experience and knowledge. Can this provider speak with authority on package materials and designs and the relevant testing methods for package validation? Can it suggest test methods to help you explore your design options? Does it hold any relevant industry certifications?

Define the testing protocol with appropriate test methods and acceptance criteria
A good starting point as a reference guide for design and evaluation of flexible primary packaging is ASTM F 2097, Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products. This document provides guidance on safety, barrier, durability, package integrity and seal strength, visibility and appearance, processing, and printed ink.

Define statistically relevant test sample sizes based on your testing objectives and your company's risk management policy and statistical rationale. Define pass/fail criteria.

Test methods must be validated. This includes your business internal procedures and the contract testing laboratory. If you are outsourcing your package testing, request a detailed testing quote. Can the provider give you full protocol and report development services? Also, seek review and approval of testing protocol from company functional experts.

Stay involved with the testing process. Review the results and report for accuracy.

Prepare a contingency plan ahead of time for test results that fail to meet acceptance criteria.


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Karen K. Greene, CPP, Vice President, Life Packaging Technology


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