Medical Device Packaging & Flexible Packaging Solutions

As an authorized DuPont Tyvek converter for the medical device industry, we deliver premium flexible packaging solutions with superior protection, tear strength, and package integrity.

Our packaging design capabilities span from peel pouches to custom bags, supported by a full range of converting services, including sheeting, folding, perforations, and specialized printing options.

We partner with medical device manufacturers from R&D through large-scale production, with redundant capabilities across multiple locations ensuring reliable sterile medical device solutions.

Medical device packaging standards ensure product sterility, protection, and safety throughout the distribution cycle. These standards encompass material selection, design validation, stability testing, and sterilization compatibility. Manufacturers must comply with ISO 11607 guidelines and regional requirements while maintaining documented evidence of conformance.

FDA requirements for medical device packaging focus on maintaining sterility and product integrity from manufacture to point of use. The packaging system must provide adequate protection, allow for sterilization, and maintain sterile barrier properties throughout the product's intended shelf life. Manufacturers must validate their packaging processes and demonstrate compliance through comprehensive documentation and testing protocols.

Primary packaging is the first layer of protective material in direct contact with the medical device, providing the critical sterile barrier system (SBS). This layer maintains device sterility and protection against environmental factors until the point of use. Primary packaging materials must be biocompatible, sterilization-compatible, and capable of maintaining integrity throughout the product's shelf life.

Packaging validation ensures that sterility and product protection are maintained from manufacture through distribution to end-use. The process includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases to verify consistent package integrity. Validation protocols must address materials, sealing processes, sterilization compatibility, and stability under various environmental conditions.

Material selection for delicate medical devices requires careful evaluation of multiple factors:

• Material compatibility with the chosen sterilization method
• Protection against physical damage during handling and transportation
• Barrier properties against moisture, oxygen, and microbial contamination
• Seal integrity and strength requirements
• Stability and shelf life performance
• Cost-effectiveness and manufacturing efficiency

Design teams should evaluate these factors early in the development process to ensure optimal packaging performance.

When selecting a medical packaging manufacturer, the most important factors are quality system certifications (ISO 13485, ISO 11607 compliance), sterilization method compatibility, whether they offer authorized materials such as DuPont™ Tyvek®, and the depth of their engineering support during design validation. Equally important is manufacturing redundancy, a single-site supplier introduces supply chain risk for commercial programs.
Evaluate whether the supplier can support you from early prototype runs through full-scale production without requiring you to re-qualify materials or suppliers as you scale. Finally, consider whether they have experience with your specific device category and sterilization process, since packaging validation is closely tied to both