Products and packaging require leak detection for quality assurance. This article compares and contrasts the two commonly used methods of pressure decay and trace gas testing and provides examples of using these techniques on a catheter and a sealed, impermeable pack.

Some of the key elements of achieving a validated packaging process are described. A peel-pouch sealing machine is used as an example.

Medical device manufacturers are compelled to validate the shelf-life claims of their products. If the materials used in the product and packaging can withstand elevated temperatures, accelerated ageing regimes may be used to simulate real-time ageing. If elevated temperatures are detrimental to the components involved, then real-time ageing is the only option. All testing should be carried out on sterile product when appropriate.

The decision on how to sterilise a medical device is dependant on many factors and as a result requires detailed investigation early in a project. The key factors are which processes are compatible with the materials and packaging used for the product. Other critical factors are cost, speed, the availability of a technology and level of customer support that is provided.

The third in a series of guides intended to help medical device engineers in specific problem areas.

Microengineering techniques now deliver much smaller products with increased accuracy and cost-effectiveness. This article looks at the opportunities offered by today's micromachining methods.