Infinity Laboratories Products & Solutions

Infinity Laboratories Products & Solutions

Packaging & Distribution Validation Testing

09 Dec 2022

Lab Tech Packaging

Infinity Laboratories has 30 years of experience helping our customers deliver safe and effective products to market.  Patient Safety is our priority and packaging systems play a critical role in the delivery of safe and sterile products to our customers.  We are here to help confirm packaging performance and integrity and can help you design and troubleshoot any packaging related issues and conduct in-depth failure analysis.

Our Packaging Testing Services include validation testing, distribution simulation, accelerated aging, material qualifications, package design, and consulting services.  Our highly qualified laboratory staff bring decades of experience and expertise to each validation and test requested.  Infinity Laboratories completes rigorous validations to ensure every package meets the requirements to protect medical devices by complying with ISO and ASTM standards.

ISO 11607 is the standard and base guidance document used for testing and validating medical device packaging.  There are two parts to this standard Part 1, “Requirements for Materials, Sterile Barrier Systems And Packaging Systems” and Part 2, “Validation Requirements for Forming, Sealing and Assembly Processes”.

Accelerated Aging and Shelf-Life Testing (ASTM F1980) are a required part of your packaging validation and are used to determine the shelf-life or expiry for your product.  Accelerated aging is an industry recognized method to achieve a desired performance benchmark, as long as real time aging is also conducted in the background.  We offer a wide range of storage and conditioning temperatures to meet the product volume requirements and timelines of your aging and shelf life validations.

Sterile Barrier and Packaging Integrity Testing are key components of the validation process.  Medical device packaging exists to protect the device and to maintain sterility.  Package Integrity testing is a key part of every sealer qualification, shelf-life, and distribution validation and our services include the following tests: Tensile Strength (ASTM F88), Gross Leak (ASTM F2096), Burst Testing (ASTM F1140), Dye Penetration (ASTM F1929) and more.

Distribution Simulation is a critical part of the packaging validation process and is required by ISO 11607-1.  The process proves that your product will arrive at the medical facility or hospital, sterile and ready for patient use.  From environmental preconditioning to drop testing, our medical device distribution testing procedures deliver fast and reliable results.  We follow ASTM D4169 and ISTA (1A – 6A) standards depending on your project requirements.

We continuously work to enhance and protect patient lives through the critical testing services that we provide.  We believe we can make a difference in the lives of patients worldwide.  Our goal is to go Beyond Testing and become a partner in the success of our customers.