Medical devices can be packaged in pouches, thermoformed blisters, or more robust thermoformed trays depending on the requirements of the device and application.
The terminology is not always consistent. Customers sometimes use the terms tray and blister interchangeably. Instead of defining the package by its name, it is more useful to look at its structure and performance requirements.
Start with the device & packaging requirements
Medical packaging development begins by understanding the device, its intended use, and what the packaging system must accomplish.
Device dimensions, shape, and critical features
Sterilization method and sterile barrier requirements
Protection and retention requirements
Number of devices or components
Handling and distribution environment
Point-of-use and aseptic presentation requirements
Production environment, including cleanroom or standard manufacturing
Quality and validation requirements
Together, these factors provide the basis for package development and help determine which packaging format is appropriate.
Medical Pouches
Medical pouches are flexible packaging systems used for a range of medical devices and components. Pouches are available in different constructions, including those using porous medical-grade materials such as Tyvek®.
Unlike thermoformed blisters and trays, a pouch does not provide a custom-formed cavity around the product. Product positioning, retention, structural support, and protection therefore become important considerations when evaluating whether a pouch is appropriate for the application.
Medical Blisters
Thermoformed medical blisters provide a rigid, custom-formed cavity to secure and protect a product. Blister designs tend to be relatively simple and are often suited to lighter, less sensitive, or less delicate devices and components that do not require substantial structural support or complex packaging features.
A medical blister can incorporate retention and product-access features along with a seal flange at sheet level for compatible medical lidding.
Medical Device Trays
Medical device trays generally provide greater structural support than blisters and can accommodate more complex packaging requirements.
Custom cavities and formed features can be designed to protect, retain, orient, and organize a device or multiple components. For procedural applications, the tray can also support point-of-use presentation by organizing components according to procedural sequence and providing access to individual items as they are needed.
For sterile barrier applications, the tray design must also account for the sealing interface. Raised seal flanges can provide clearance between the packaged product and the lidding material while creating a consistent surface for sealing and access for package opening.
Choosing the Right Medical Packaging Format
There is no universal rule for whether a medical device should be packaged in a pouch, blister, or tray. The appropriate format depends on the level of protection, retention, structural support, organization, sterile barrier performance, and point-of-use functionality required by the application.
Medical device manufacturers typically begin the development process with an understanding of their device, sterilization method, production environment, and packaging requirements. Dordan's engineering team uses those inputs to develop the package design, guide material type and thickness, determine the tooling approach, and establish applicable quality requirements.
Dordan manufactures medical packaging in its ISO Class 8 cleanroom under an ISO 13485:2016-certified quality management system. The resulting package is developed around the device and how it will move through manufacturing, sterilization, distribution, and point of use.
Develop Your Medical Packaging Application
Share your device specifications, sterilization method, packaging requirements, and production needs with Dordan to begin developing a custom thermoformed medical packaging solution.