Packaging and sterilisation for Active MedTech

Most active medical devices need to be delivered in appropriate packaging and many need to be sterilised for use in a variety of healthcare contexts. Of particular interest for Active MedTech is the need to ensure that sensitive electronics are not damaged in the sterilisation process.

This presentation examines the range of options and requirements involved in this critical aspect of product development. Virtually all Active MedTech devices need to be packaged, regardless of whether they need to be sterile or not. Packaging needs to protect the product during transport and ensure it is fit for purpose when unpackaged ready for use. The packaging process involves the development of prototypes for evaluation and testing. 

Typically packaging will involve the manufacture of pre-formed plastic shapes to fit the product, which can be sealed if it is required to be sterilised. A range of packaging materials is available to suit various applications. 

One of the most important aspects for regulatory purposes is the development of a validation plan, which must address all the planned modes or configurations the package must go through before reaching the customer. 

The main sterilisation options include gamma rays and ethylene oxide gas. The application and relative benefits of these approaches are discussed, particularly in relation to active devices. The sterilisation process must then be validated to ensure the device's sterilisation process is effective and safe. We look at the requirements of the ISO 11607 standard on Sterile Barrier Packaging.

Other subjects to be covered include accelerated aging tests (ASTM 1980), transport testing (ASTMD4169), printed material performance testing, sterility vaidation (ISO1135) and more. 

This webinar will be presented by Sabre Medical CEO Doug Watson.