Ensuring Regulatory Compliance of Thermoformed Trays for Medical Devices

Thermoformed trays are the trusted solution for organizing, protecting, and maintaining the sterile integrity of delicate medical instruments and devices. The packaging solution helps medical OEMs prioritize device and patient safety while also meeting International Organization for Standardization (ISO) and U.S. Food & Drug Administration (FDA) regulatory requirements.

Determining which medical applications are best suited for thermoformed trays

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

Device 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. However, 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.

To illustrate the point, thermoformed trays are ideal solutions for these representative complex medical applications:

• Orthopedic devices that restore skeletal systems, such as artificial joints
• Minimally invasive robotics and instruments that eliminate the need for major incisions during operations
• Electro-mechanical devices that use electrical pulses to create a mechanical movement that precisely controls motion (e.g., ventilators, pacemakers, defibrillators)
• Procedure kits that combine several medical devices needed to perform a single medical procedure
• Catheters, guidewires, and stents used in cardiovascular procedures and select other medical events
• Injection systems containing syringes and needles that facilitate the delivery of drugs, vaccines, and biopharmaceuticals

Compliance Standards & Regulations

Medical packaging compliance can be complicated. There are a number of ISO and FDA requirements that apply to thermoformed trays, briefly outlined below.

ISO 11607 (Parts 1 & 2)

ISO 11607 Parts 1 and 2 govern medical device packaging systems design and validation.

• ISO 11607 Part 1 specifies general packaging system requirements for terminally sterilized medical devices, including:

  • Materials selection
  • Package design and integrity
  • Sterile barrier properties
  • Packaging process validation

• ISO 11607 Part 2 focuses on elements and execution of packaging process validation, including:

  • Developing a packaging process validation plan
  • Establishing and maintaining a validated packaging process
  • Conducting performance qualification and documenting results

ISO Parts 1 and 2 work in tandem to ensure medical devices remain sterile until point of use, thereby maximizing patient safety.

ISO 10993

ISO 10993 is the global standard for testing and determining medical device biocompatibility. Since certain packaging materials such as thermoformed trays naturally interact with medical devices, they could present chemical contamination risk to sterile medical devices, and ultimately, risk to patient safety.

As such, ISO 10993 provides comprehensive guidance on biocompatibility tests packaging suppliers must perform to objectively assess thermoformed trays:

• Chemical characterization
• Toxicity testing
• Material extraction
• Irritation and sensitization testing

ISO 13485

ISO 13485 is the most widely used international standard for medical device quality management systems. Medical packaging suppliers such as Amcor that carry ISO 13485 certification have demonstrated compliance with requirements pertaining to:

• Establishing a quality management system that covers packaging material and process integrity
• Managing risk throughout packaging design, production, and use; including the implementation of risk mitigation controls
• Documenting packaging design and development processes to ensure packaging meets the regulatory requirements and safety needs of the medical device
• Using specific criteria to evaluate and partner with materials suppliers to maintain quality standards, with secondary emphasis on routine supplier monitoring and assessment to ensure consistency in thermoformed tray materials and quality
• Maintaining documented procedures for packaging processes, records maintenance related to inspections and testing, and materials traceability

FDA CFR Title 21, Part 820

The FDA is very specific about medical device quality system regulation. CFR Title 21, Part 820, is devoted to the topic. It focuses on six specific areas: medical device design, manufacturing, packaging, labeling, storing, and servicing.

Experienced packaging suppliers are proactive in addressing medical device sterilization. Packaging is subjected to rigorous testing that proves a package 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
• Labeling protocols with unique device identification (UDI) and other identifying information to support chain of custody and traceability

Comprehensive testing and documentation is typically required for OEMs to get regulatory agency approval for thermoformed trays and other medical device packaging. As such, collaboration with a trusted packaging supplier is critical to administer the appropriate performance tests and capture the necessary results that demonstrate compliance.

Thermoformed Trays Performance Testing and Documentation

• Explain the different types of performance tests applicable to thermoformed trays.
• Highlight the significance of microbiological testing for medical device packaging.
• Discuss cytotoxicity testing and biocompatibility testing for materials used in thermoformed trays.
• Discuss documentation requirements, including Material Data Sheets, "REACH" compliance, latex-free documentation, and material traceability.
• Audit process

Amcor Guides Customers to Successful Thermoformed Trays

Amcor is the world leader in packaging because of our commitment to doing whatever it takes to help our customers succeed. Our experience and expertise has made Amcor the trusted name in medical device packaging.

From materials selection to world-class facilities that support strategic packaging design, development, prototyping, and regulatory compliance including clean room protocols, Amcor is the packaging supplier medical OEMs turn to for thermoformed tray solutions.

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