Medical Trays & Thermoformed Medical Packaging | ISO 13485:2016 Certified

 

• Package Design – Using Siemens NX for part modeling and tooling development

• In-House Tooling – CNC machined prototype and production tooling

• Thermoforming – 12 thin-gauge thermoformers, including cleanroom operation

• Cleanroom Manufacturing – Full production under ISO Class 8 conditions

• ISO 9001:2015 and ISO 13485:2016 Certified – First article validation, process capability studies, PPAPs

This integrated approach improves speed, traceability, and consistency throughout the medical packaging development process.

Markets We Serve in Medical Packaging

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Dordan partners with medical device OEMs, contract manufacturers, and healthcare suppliers to deliver custom thermoformed packaging solutions engineered for sterility, safety, and compliance. Our expertise supports a wide range of medical and pharmaceutical applications, including:

Medical Device Manufacturers: We design and manufacture medical trays, blisters, and clamshells that protect and maintain the sterility of single-use and reusable medical devices—from orthopedic implants to surgical instruments and diagnostic tools.

Surgical and Procedural Kit Providers: Our thermoformed trays for surgical and procedural kits are custom-configured for organized instrument layout, intuitive use, and efficient sterilization. Ideal for both sterile and non-sterile packaging formats.

Contract Manufacturers and Assemblers: Dordan supplies handling and assembly trays used in manufacturing, staging, and cleanroom assembly of medical components and kits. Our trays are automation-ready and designed for durability and precision.

Pharmaceutical and Diagnostic Applications: We manufacture rigid plastic blisters and trays used for packaging pharmaceuticals, diagnostic kits, and other regulated healthcare products—ensuring proper containment, labeling, and compliance throughout the supply chain.

ISO Class 8 Cleanroom Medical Packaging

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Dordan’s ISO Class 8 certified cleanroom is purpose-built for the manufacture of medical packaging with tight form and cut tolerances and contamination control.

The cleanroom features:

• Keifel Speedformers with automated forming, cutting, stripping, and stacking

• Terminal cleaning protocols and FDA-certified material handling processes

• Particulate and bioburden monitoring in compliance with ISO 14644

• Automated optical inspection for CPK data and real-time quality analysis

• GMP-based gowning, material handling, and terminal cleaning protocols

All cleanroom production is supported by:

• First Article Validation (FAV) and full dimensional reports

• Process capability studies (CPK) with optical inspection technology

• Lot traceability, material certification, and change control documentation

All cleanroom operations are governed by our ISO Class 8 certified quality management system, which ensures the production of consistently clean, on-spec packaging for critical healthcare applications

Quality Assurance in Medical Packaging

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At Dordan, quality control isn’t just a standard—it’s a systemized, validated process built into every custom medical packaging solution we produce. From ISO-certified production protocols to material traceability and cleanroom manufacturing, we ensure that every medical tray, blister, or kit meets the most stringent regulatory, performance, and cleanliness requirements.

ISO-Certified Medical Packaging Manufacturing

• ISO 13485:2016 Certified – for the design and manufacture of medical-grade thermoformed packaging. This certification reflects our ability to meet global regulatory requirements for medical devices and ensures a risk-based approach to quality control.

• ISO 9001:2015 Certified – for total quality management across all operations, emphasizing process consistency, documentation, and continuous improvement.

Process Validation & Quality Control

• First Article Inspection (FAI) to verify dimensional accuracy and design intent prior to production.

• Process Validations (IQ, OQ, PQ) to establish and document consistent performance and repeatability in medical packaging manufacturing.

• Statistical Process Control (SPC) and CPK analysis to monitor and maintain critical dimensions during forming and trimming operations.

• Post-production Sampling using Acceptable Quality Level (AQL) standards to verify lot conformity and compliance.

• Automated Optical Inspection to non-destructively validate high-tolerance features and geometries.

Traceability & Regulatory Support

We maintain complete lot-level traceability, linking material certifications, tooling data, inspection records, and production runs. All materials used in medical packaging production are sourced from FDA-compliant suppliers and selected to align with your sterilization and end-use requirements, including gamma, EtO, and e-beam compatibility.

From prototype to production, Dordan’s ISO-certified quality systems and manufacturing capabilities ensure that your medical packaging meets the highest standards of safety, compliance, and performance—every time.

Why Leading Medical Companies Choose Dordan

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