Newsletter | November 9, 2020

11.09.20 -- Considerations For Package Integrity Testing And Seal Quality Inspection

Automation Of Class III Medical Device Packaging

When assuring the quality of all packaged products, testing container closure integrity (CCI) is critical, especially as it relates to Class III medical devices. This article explores the need for sensitive, fast, and reliable automated CCI testing technologies and how existing solutions can help achieve optimum quality goals for medical device manufacturers.

Medical Device Tyvek Seal Quality And Peel Strength

Medical device packages face unique challenges along with stringent requirements. Tyvek seal strength is critical for a product to survive transportation, shipping, and storage. Peelability of the pouch is equally as critical, providing those in a surgical environment the ability to deliver a device effectively into the sterile field while maintaining sterility. 

Moisture And Oxygen Risk In The Medical Device Industry

The majority of medical device packaging is porous in nature. Some medical devices require a different layer of defense protecting against oxygen or moisture ingress. For some devices, the ingress of moisture or oxygen over the shelf-life of the product can impact the device performance. Any time a foil barrier comes into play with a high-risk application, detection of microleaks is absolutely critical to assuring the shelf-life of the products.

Package Inspection Considerations For Class III Medical Devices

Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection method. This e-book covers a variety of inspection methods and benefits and downfalls for each one.