Pouch Systems

Precision Packaging: Sterility, Speed, and Safety

At Eagle Medical, our sterile pouch systems are engineered to provide high-performance protection, fast-cycle compatibility, and airtight compliance, especially for complex, sensitive, or mixed-format medical devices.

Using Tyvek®, multi-layer films, and advanced sealing technologies, we build pouch configurations that support your device’s unique geometry, sterilization pathway, and clinical use case. Whether you need validated single-barrier packaging or custom pouching within a kitted configuration, we’ll help you achieve it faster and with full documentation support.

Configurable Formats for Diverse Needs

We offer a wide variety of validated pouch formats and material combinations, tailored for your product’s performance, cost, and regulatory requirements:

Single- and double-barrier pouches for primary and secondary protection
Internal supports including custom backer cards and thermoform inserts
Pouch-and-vial combinations for delicate or multi-part systems
Kitting compatibility for mixed-modality sterilization (VH₂O₂, EtO, gamma)
Tyvek®-to-Tyvek® and Tyvek®-to-film pouches for optimal breathability
Foil-lined and light-blocking options for photosensitive or UV-sensitive devices
Vacuum-sealed formats for enhanced shelf life and stability

All pouch solutions are assembled in our ISO Class 7 cleanrooms and are fully compatible with our VH₂O₂ and EtO sterilization services, ensuring end-to-end system integrity under one roof.

Designed with Validation in Mind

Every pouch system we produce is backed by a rigorous and traceable validation framework. Our services include:

ASTM F1929 and ISO 11607-1/2 compliance for sterile barrier systems
Seal integrity testing, burst testing, and dye migration studies
Accelerated aging and real-time shelf-life testing
Sterilization compatibility documentation for FDA and ISO submissions
Pre-validated pouch systems to reduce time-to-launch
Support for True-Validated™ hybrid packaging platforms

If your product is still in development, we can help define the ideal packaging configuration in parallel with your sterilization and assembly pathways, streamlining verification and reducing design-phase risk.

Built for the Real World

We don’t just make pouches. We make systems that hold up in the real world. Our engineers help you account for:

Puncture, abrasion, and tear resistance during transit and storage
Moisture, humidity, and oxygen barrier needs
Light sensitivity and material opacity
Ease of clinical presentation and aseptic opening

And because our team works directly with sterilization, assembly, and packaging under one roof, we ensure your pouch performs not just in testing, but in practice.

Why Eagle Medical?

Over 30 years of sterile packaging expertise
Industry-leading experience in VH₂O₂ sterilization and validation
Agile support for prototypes, pilot runs, and full-scale production
Part of the West Coast Device Alliance (WCDA), giving you access to integrated launch solutions

Express Solutions

Packaging Accelerated Timeline Help (PATH)

Packaging Development Completed in Under 3 Weeks

This innovative offering will dramatically reduce your time to market while ensuring your device packaging will protect your product and comply with international standards and requirements.

Coming Soon

Readipouch

Your fully preconfigured and complete packaging solution

Need more than just a prevalidated seal on a pouch? This is your solution! Readipouch consists of Pre-Configured, Pre-Structured, Pre-Validated (Pre-CSV) medical device packaging components. It is the only pre-validated sterile barrier solution, combining pre-configured secondary packaging.

Customized Solution

For devices that have a unique set of requirements that don't conform to our OTS or CSV offerings, we'll design your custom packaging system or we'll use your pre-configured design inputs.