Packaging & Sterilization

Hart designs and manufactures packaging solutions that protect medical devices throughout handling, sterilization, shipment, and point-of-use. We engineer packaging to align with your sterilization pathway, product geometry, material requirements, and regulatory standards. Whether you need simple pouch packaging or complex multi-component protection, Hart provides validated, inspection-ready solutions that integrate seamlessly with your device.

Packaging Designed for Validated Sterilization Pathways

Hart selects and processes plastics based on how they will behave in use, not just how they look on paper. We consider mechanical strength, chemical exposure, sterilization compatibility, and ergonomic requirements to build components that support safe, reliable operation in the field.

Inspection and Protection From Pack-Out to Post-Sterilization

We combine metal and plastic features through precise insert molding that supports durability, repeatability, and consistent alignment. Our molding strategies reduce multi-step assembly costs, minimize weak points, and create reliable bonds between dissimilar materials.

Flexible Packaging Options From Simple Parts to Complex Assemblies

Whether you need a unique mold or can leverage an existing design, Hart manufactures plastic components using tooling options that balance budget, speed, and scalability. We support rapid prototyping, low-volume test runs, and optimized commercial tooling for sustained production.

Packaging Design and Manufacturing That Perfectly Meets Your Sterilization Parameters

Sterilization is not an afterthought—it’s a critical step in device development. Hart engineers packaging based on material compatibility, cycle efficiency, seal strength, barrier properties, and ease of opening in a clinical environment. We collaborate early with device teams to understand product geometry and sterilization method, helping avoid failures such as compromised seals, weak vents, film bursts, sterile barrier breaches, or label degradation. Your finished product reaches the field protected, validated, and ready for use.
100% Engineered and Manufactured in the US
Founder-owned and operated since 1976
FDA Registered & ISO 13485 Certified

Our Core Custom Capabilities

From simple sterile pouches to complex component protection, Hart supports packaging design, documentation, testing, and full-scale production. Our solutions pair device safety with regulatory compliance and manufacturing efficiency.

Sterile-Ready Packaging Solutions for ETO and Gamma Processes

We provide materials and seal systems engineered to withstand ethylene oxide (ETO) and gamma sterilization. Hart evaluates permeability, film strength, adhesives, and compatibility to ensure your packaging maintains a sterile barrier through every cycle.

Sterilization-Approved Packaging Configurations

Flat pouches, vented pouches, foam-protected components, layered systems, and custom form-fit guards are tailored to product dimensions and clinical requirements. We design to simplify pack-out, minimize waste, and improve usability without compromising sterile integrity.

Post-Sterilization Visual Inspection & Mechanical Testing

Hart conducts seal validation, peel testing, tensile strength evaluation, and visual inspection for post-sterilization stability. Our testing ensures that the sterile barrier remains intact through transport, storage, and procedural handling.

Case Studies

Explore how Hart’s engineering expertise has helped medical device manufacturers overcome unique design and manufacturing challenges. Each case study highlights our problem-solving approach and the measurable impact for our partners.

How One Medical Device Program Became a Long-Term Manufacturing Partnership

For complex medical devices, there are frequently multiple opportunities for improvement. Materials, assembly methods, packaging, and production flow all contribute to the ultimate success or failure of a complex device. When one thing goes wrong, it affects everything else down the line.
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Optimization and Partnership for Reliable Endoscopic Needles

Hart partners with OEMs to design and build complete medical components and assemblies. Our integrated process combines engineering insight with full-scale production efficiency.
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Scalable, Flexible Approaches to Custom Ophthalmic Surgical Devices

We design and manufacture precision needles for specialized medical applications. Hart engineers to meet exact performance needs through collaboration, quality, and decades of expertise.
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Talk to Our Engineers

Our engineers are ready to collaborate with you on your next product. Whether you’re refining an existing design or developing a new device, Hart’s deep manufacturing experience ensures faster timelines, lower costs, and uncompromising quality.

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