Packaging and Sterilisation of Medical Devices

Written by Luke Sy on 2nd Sept. 2020

Packaging is indispensable in any product, and medical devices are of no exception. In the webinar, Douglas Watson from Sabre Medical talked specifically about packaging and sterilization of medical devices. A key mantra in wise medical device packaging is to “label appropriately and label wisely”. Indeed, the requirement to label each of the claims made appropriately is one of the key difference of medical packaging vs general packaging. The claims can be related to the packaging barrier (ISO 11607), transportation (ASTMD4169), packaging material aging (ASTM1980), and sterility validation (ISO 11135 or ISO11137). Indeed, the ultimate goal of the package and packaging material is to contain the product and maintain a sterile/clean environment, protect the product from damage throughout the full transportation cycle, inform the user of what the product is and how to use it, and to extend the products shelf life.

Design and Development

Package design and development should at least consider the following. The main goal is to ensure device integrity and sterility.

  1. Customer requirements - ISO11607 requires packagers to conduct a documented test demonstrating that using the product is easy, safe, and aseptic (i.e., free from contamination).
  2. Production volumes - A typical design strategy is to manufacture in Australia at small volumes, then opt for offshore packaging at high volume and when there are minimal changes to product design.
  3. Usability factors - Packaging strategy can greatly affect product adoption of market. An example strategy is the use of elegant and fancy packaging for new products entering the market to give good user impression and accelerate adoption. Then, later on, when a good adoption rate is achieved, the product owner can switch to simpler and less expensive packaging.
  4. Maintaining package integrity up to the point of use. It includes showing the product permits sterilisation (allows Ethelene Oxide gas to flow through). Circuit boards are typically hermetically sealed, though ESD protection tends to be a challenge. To minimize product inventory, multiple product configurations can be used where each unit have ready-made packaging docs.

Packaging

Packaging presentation is typically either pouch or rigid tray, where preference typically depends on the target country and volume. Unfortunately, the materials used in medical packaging are usually non-biocompatible and is something to be improved in the future. Package sterilisation can be achieved through the use of Ethelene Oxide Gas or Gamma/EBeam where the latter degrades some materials and is sometimes responsible for the unique smell one encounters when opening a medical packaging. Lastly, packaging validation typically involves machines which test seal integrity and strength, accelerated aging, and transport testing.