HealthCare™ Thermoformed Trays that protect products, patients, and sterility

When you’re responsible for delivering safe, sterile medical devices and pharmaceutical products, you need packaging that performs every time. Amcor’s portfolio of HealthCare™ Thermoformed Trays helps you:

• Keep components sterile and protected, maintaining integrity from production to the point of use
• Simplify compliance with ISO and FDA requirements, reducing regulatory risks and delays
• Ensure supply continuity through cleanroom production and global availability
• Advance your sustainability goals with material options that support more responsible packaging

In short, you get packaging that helps you protect patients, meet regulations, and strengthen trust in your brand.

When are Thermoformed Trays the Right Choice?

There are hundreds of medical and pharmaceutical applications requiring packaging, but not all applications require the sophistication of thermoformed trays.

Product characteristics are key considerations in determining when thermoformed medical packaging is warranted. High-value medical devices commonly require a thermoformed tray to protect the substantial investment. Other factors such as delicate instrumentation, restrictions to prohibit accidental device activation, or the need for package rigidity for proper device handling and presentation often drive packaging decisions.

That explains why thermoformed trays are ideal for orthopaedic devices that restore skeletal systems, such as artificial joints. They are also highly suitable for minimally invasive robotics and electromechanical devices such as ventilators, pacemakers, and defibrillators.

Other products that benefit from the extra protection of thermoformed trays include procedure kits that combine several medical devices, catheters, guidewires, and stents used in cardiovascular procedures. Plus, syringes that facilitate the delivery of drugs, vaccines, and biopharmaceuticals.

Built for Compliance and Confidence

Medical packaging compliance can be complicated. There are several ISO and FDA requirements that apply, and Amcor’s HealthCare™ Thermoformed Trays are designed and manufactured to meet the most rigorous global standards, such as:

• ISO 11607 ensures sterile barrier integrity and validated packaging processes
• ISO 10993 addresses biocompatibility, minimizing contamination risks
• ISO 13485 certifies our quality management systems for medical packaging
• FDA CFR Title 21, Part 820 governs design, labelling, and traceability

Experienced packaging suppliers proactively address medical device sterilization. Packaging is subjected to rigorous testing that proves it will protect devices from environmental factors that could threaten sterilization.

To determine the resiliency of the sterile barrier of the thermoformed tray, medical device packaging is subjected to validation testing that includes:
• Real-time aging
• Accelerated aging
• Bubble emission and burst testing
• Packaging equipment installation, operational efficiencies, and performance qualifications that demonstrate the equipment works properly, packaging assembly processes are accurate, and sterile barrier requirements are met
• Labelling protocols with unique device identification (UDI) and other identifying information to support chain of custody and traceability

Comprehensive testing and documentation are typically required for our customers to get regulatory agency approval for their product and packaging. As such, collaboration is critical to administer the appropriate performance tests and capture the necessary results that demonstrate compliance.

Amcor Guides Customers to Successful Thermoformed Trays

Amcor is a world leader in packaging because of our commitment to provide the very best solution for our customers, no matter what the challenges might be. Our experience and expertise have made Amcor the trusted name in healthcare packaging.

We partner with our customers to offer more sustainable material selection, as well as world-class facilities that support strategic packaging design, development, prototyping, and regulatory compliance, including clean room protocols.

A global partner you can count on

Amcor’s global footprint and manufacturing capabilities mean we can deliver consistent quality and supply continuity no matter where our customers operate.

With production sites and technical centers across the Americas, Europe, and Asia, Amcor offers true worldwide reach backed by local expertise. Our teams share best practices across regions, ensuring consistency, speed, and regulatory alignment wherever your products are made or delivered. This global network means you benefit from faster development cycles, reliable supply continuity, and expert guidance at every stage of your project.

The Amcor Technical Optimization Services (TOS) team works closely with our customers to help navigate the complexities of thermoformed medical packaging compliance within a highly regulated and specialized industry.

Get in touch to discuss your healthcare packaging needs. Contact our expert healthcare team today..