Medical packaging validating

This presentation will cover the development of simulation for thermoformed custom packaging, design, product integrity testing, predicted behaviour and performance, and first prototype samples.

The session will also examine how simulation can provide data on material thickness during forming and how it can impact drop testing and reduce material gauge towards more sustainable solutions.

Product testing is used to ensure all areas of the instrument set—especially the areas most resistant to the sterilant—are properly sterilized.

Wet packs are considered contaminated and cannot be used.

Chemical indictors are placed in the area of the instrument set that is least accessible to the sterilant—not necessarily in the middle or top (photo on p 27).

On the show floor, professionals from all areas of the medical device supply chain will demonstrate their newest and most exciting solutions for ambitious technology users.

Highlighted below are just some of the packaging exhibitors this year: Nelipak, a global leader in Healthcare Thermoformed Packaging with world class reputation for quality and service will be on stand F3.

In a recent article for Med-Tech Innovation, Sean Egan, Nelipak explained: “Involving a packaging partner at the earliest stages of product development can allow for the creation of innovative packaging that is both fit-for-purpose and as sustainable as possible.” The discussion will encompass package integrity testing, USP 1207, and regulatory shifts to come.

Taking the right approach to establish package quality testing protocols and implementing the proper test method is necessary to reduce patient or consumer risk by delivering high-quality, defect-free packaging.

Sterilization packaging is considered a medical device and thus it must undergo validation testing before being used in healthcare facilities.

To ensure proper packaging that will maintain the integrity of sterilization, consult the packaging manufacturers’ instructions for use (IFU) and follow the sterilization standards and guidelines from the Association for the Advancement of Medical Instrumentation (AAMI) and AORN.

Contamination of sterile packaging is considered an “event” that can result from a tear, dropped package, wet package, storing the package in a contaminated area, or discovering that a package is already open.


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