Flexible Film & Packaging

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.

We are a custom, scalable manufacturer of flexible packaging that handles blown film extrusion and conversion for both non-sterile and sterile product lines for medical applications. We are one of a few authorized converters of DuPont Tyvek for the healthcare industry. This ensures the highest level of protection, superior tear strength, and is puncture resistant.

We offer a wide variety of products including:

• Peel pouches
• Linear tear bags (both coated and uncoated)
• Header bags
• A variety of custom bags and pouches

We also offer additional services such as:

• Sheeting
• Folding
• Perforations
• Slitting
• Venting
• Punching
• Both inline and offline printing

We can work with customers at the very beginning stages of R&D for prototypes and small batch runs, all the way up to large-scale production.

It's important to note that our capabilities are redundant across multiple locations; therefore, our customers have peace of mind that we have risk mitigation built into our process.

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.