3 steps for designing the ideal medical device packaging system: Page 3 of 3

Brian Whalen in Medical Packaging on January 23, 2017


3. Utilize a robust testing protocol.

Packaging concerns should be addressed from the very first step of the project to quickly identify unforeseen contingencies in design. Short-cuts simply cannot be taken during this critical testing process. ISO 11607: Packaging for Terminally Sterilized Medical Devices, published in 2006, is the principal reference guide for medical device packaging and includes information on testing requirements. ASTM and ISTA Series distribution testing offer a set of specific test methods for compliance with ISO 11607.

For guidance related to a specific medical device packaging system, collaboration between a project team and an ISO 17025 accredited laboratory is necessary to ensure the proper test methods are utilized. Establishing a protocol prior to testing complete with clearly understood pass/fail criteria is paramount to identify problem areas in packaging design. A robust protocol would include scope, responsibilities, appropriate sample size, production equipment, parameters, and acceptance criteria, to name a few.

Your Ideal Packaging System

In the competitive landscape of the current medical device marketplace, almost as important as the medical device is the package it arrives in. Packaging today has evolved from an afterthought to an integral part of the device user’s experience. In many cases, the packaging system is designed to be as unique as the device itself. Much needs to be considered in the process. The packaging system must maintain the sterile barrier system, protect the device while in transit and use, and successfully communicate the device maker’s branding and value proposition. When this process is considered early with great intent and purpose, mistakes can be avoided, costs can be saved, and the ideal packaging system can be created.

Brian Whalen (above) is director of sales & marketing for CleanCut Technologies LLC (www.cleancuttek.com). The company will be exhibiting at Booth #1361 at MD&M West in Anaheim, CA, February 7-9, 2017.

All images in this article are provided by CleanCut Technologies.


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Nice technique of packaging, its very important to secure the medical items.
Another area for consideration is the aseptic presentation at the point of use. Will the presentation be in a surgical suite or in the field? Also, nurses want products within a family of sizes to be quickly identifiable, such as sutures of various lengths or surgical gloves. Great start to identifying some of the design aspects for packaging.