Eagle Medical's packaging division specializes in the design and manufacturing of sterile barrier systems that protect medical devices throughout their lifecycle. Our comprehensive packaging solutions ensure product sterility, facilitate aseptic presentation, and meet stringent regulatory requirements while optimizing cost-effectiveness and user experience.
Core Packaging Technologies
Sterile Barrier Pouches
Chevron and straight-edge pouch configurations for various device geometries
Multi-layer laminate construction with optimized barrier properties
Transparent and opaque film options for product visibility requirements
Custom sizing and configuration for specific device applications
Backer-Card Systems
Rigid and semi-rigid backer-card designs for device protection and presentation
Thermoformed trays with integrated sealing surfaces
Medical-grade paperboard and plastic substrate options
Custom printing and labeling integration capabilities
Tyvek Lidstock Applications
High-performance Tyvek lidding films for breathable sterilization
Coextruded and adhesive-laminated constructions
Peelable and non-peelable sealing characteristics
Chemical indicator and print-compatible formulations
Material ScienceDesign & EngineeringManufacturingFAQ
Barrier Film Technologies
Polyethylene and polypropylene base films with enhanced puncture resistance
Nylon and polyester layers for improved mechanical properties
EVOH and aluminum oxide barrier coatings for extended shelf-life
Medical-grade adhesives and heat-seal coatings
Sterilization Compatibility
Ethylene oxide (EtO) permeable materials with validated degassing characteristics
Gamma radiation-stable formulations with minimal property degradation
Steam sterilization-compatible materials for autoclave applications
E-beam compatible substrates for high-throughput sterilization
Custom Packaging Development
Device-specific packaging design optimization
Sterile barrier validation and testing protocols
Package integrity testing and shelf-life studies
Aseptic presentation and ease-of-opening evaluations
Regulatory Compliance Support
ASTM F1929 and ISO 11607 standard compliance for sterile barrier systems
FDA packaging validation documentation support
European MDR packaging requirement alignment
Design control and risk management integration
Performance Optimization
Seal strength and peel force optimization
Microbial barrier effectiveness validation
Environmental stress testing and accelerated aging
Distribution and handling simulation studies
Production Flexibility
Small-batch custom manufacturing for R&D and clinical trials
Scalable production capacity for commercial volume requirements
Multi-format capability supporting various pouch sizes and configurations
Just-in-time delivery and inventory management programs
Quality Systems Integration
ISO 13485:2016 certified manufacturing processes
Statistical process control for critical packaging parameters
Comprehensive incoming material inspection and testing
Finished product validation and release testing protocols
Value-Added Services
Complete packaging solutions including:
Primary packaging design and secondary packaging integration
Labeling and serialization capabilities
Kit assembly and combination product packaging
Supply chain optimization and vendor management
Complete Solutions Partnership
Eagle Medical's packaging expertise enables medical device manufacturers to achieve optimal sterile barrier performance while reducing development time and ensuring regulatory compliance. Our integrated design-to-manufacturing approach delivers cost-effective packaging solutions that enhance product protection and user experience.
Frequently Asked Questions
Our packaging materials are designed to be compatible with all major sterilization methods including Ethylene Oxide (EtO), Gamma radiation, E-beam, Steam, and Hydrogen Peroxide Gas Plasma (HPGP). We provide complete sterilization compatibility documentation and validation support for each material specification.
We ensure compliance through adherence to ASTM F1929 and ISO 11607 standards for sterile barrier systems. Our quality systems are ISO 13485:2016 certified, and we provide comprehensive documentation support for FDA 510(k) submissions and European MDR requirements. All packaging designs undergo rigorous validation testing including package integrity, microbial barrier effectiveness, and shelf-life studies.
Development timelines vary based on complexity, but typically range from 4-12 weeks for custom packaging solutions. This includes initial design consultation, material selection, prototype development, validation testing, and final approval. For urgent projects or simple modifications to existing designs, we can often accelerate timelines significantly.
Yes, we specialize in small-batch custom manufacturing for R&D and clinical trial applications. Our flexible production capabilities allow us to manufacture quantities as small as 100 units while maintaining the same quality standards as high-volume production. This enables cost-effective validation of packaging designs before commercial scale-up.
We provide comprehensive testing including package integrity testing, seal strength and peel force optimization, microbial barrier effectiveness validation, environmental stress testing, accelerated aging studies, and distribution simulation. All testing follows established industry standards and can be customized to meet specific regulatory requirements for your target markets.
Yes, we provide complete packaging solutions including primary and secondary packaging integration, labeling and serialization capabilities, kit assembly for combination products, and supply chain optimization. Our value-added services extend to vendor management and just-in-time delivery programs to streamline your entire packaging supply chain.
Ready to Collaborate?
Partner with Eagle Medical's packaging engineering team to develop sterile barrier solutions that meet your specific device requirements and regulatory objectives.
