This week’s blog is an excerpt from an article written by LSO’s Ken Shagagi

Packaging for medical devices, related products and materials is highly regulated and must meet very specific requirements. The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device. The primary standard governing medical device packaging and shelf life validation is ISO 11607-1. The intent behind this standard is “To provide designers and manufacturers of medical devices with a framework of laboratory tests and evaluations that can be used to qualify the overall performance of the package used to protect the device components during handling, distribution, and storage.”

There is more to medical device packaging than simply creating a flashy package that gets consumers’ attention. Package design, while being cost effective to the manufacturer, should be tailored to the end user for optimum ease of use, safety and product protection.

The materials used in packaging devices play as important a role as the colours and design, protecting the device as much as providing quality packaging. The paper used to make folding carton packaging is an important part of medical device manufacturing.

The four main types of substrates used in folding cartons are:

  • Unbleached kraft paperboard is the most common material used for folding cartons
  • Bleached kraft, also called solid bleached sulfate, is the highest quality and most expensive paperboard substrate
  • Recycled paperboard is made from recovered paper, and represents the single largest market for recovered paper in the United States
  • Small flute corrugate has added strength and rigidity due to its construction, but this also adds cost to the converting process. It is usually used in high-end packaging where strength and stiffness are important

The process of developing and constructing a packaging system for terminally sterilized medical devices is a convoluted and pressing endeavour. The definitive nature of the medical device, the intended sterilisation methods, the intended use, expiration date, transport, and storage all influence the packaging system design and choice of materials. The combination of the medical device and the packaging system should perform efficiently, safely, and adequately in the end user’s hands.

To read the article in its entirety click here: Boxed to Perfect Standards