Dordan Manufacturing is a fourth-generation, family-owned manufacturer of high-quality thermoformed medical packaging. From concept to production, we provide custom medical device trays, blisters, clamshells, kits, and handling trays engineered for safety, compliance, and performance. Certified to ISO 13485:2016 and ISO 9001:2015, Dordan offers full-service medical packaging solutions backed by in-house design, tooling, plastics thermoforming, and ISO Class 8 cleanroom manufacturing.
Key benefits of thermoformed medical packaging include:
Custom Fit and Protection: Each package is tailored to the specific dimensions of the medical device, ensuring a snug fit that minimizes movement and potential damage during transportation and storage.
Sterility Maintenance: Designed to accommodate sterilization processes, thermoformed packages help maintain the sterility of medical devices until the point of use.
Material Versatility: Utilizes medical-grade plastics such as PETG and HIPS, which are known for their clarity, strength, and compatibility with sterilization methods.
Cost-Effective for Medium & High Volumes: Once the tooling is created, thermoforming allows for rapid production of large quantities, making it a cost-effective solution for high-volume needs.
Design Flexibility: Capable of producing complex shapes and features, including compartments, flanges, and seals, to meet diverse medical packaging requirements.
We specialize in custom thermoformed medical trays and packaging for a wide range of applications, including:
Medical Device Trays: Secure and sealable trays designed to hold and protect devices such as implants, surgical tools, and diagnostic equipment
Surgical and Procedural Kits: Organized trays for single-use and reusable instruments, configured to improve OR workflow and reduce setup time
Medical Blister Packaging: Thermoformed blisters sealed to foil or Tyvek® that offer tamper resistance and unit-dose protection
Medical Clamshells: Durable, hinged packaging used for syringes, tubing sets, and other device components
Component Handling & Assembly Trays: Designed for cleanroom assembly, automation, and shipping of medical components
We provide end-to-end medical packaging solutions, including:
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.
Our medical packaging 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.
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
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 and Validation 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.
ISO 13485:2016 & ISO 9001:2015 Certified
ISO Class 8 Cleanroom Manufacturing
Production-Intent Prototyping & In-House Tooling
Medical-Grade Materials & Sterilization Compatibility
Validation & Regulatory Support
Vertically Integrated U.S. Manufacturing
4th Generation Family Owned and Operated Since 1962
Request a Free Medical Packaging Consultation
Need help developing your next thermoformed medical tray or surgical kit package? Contact Us today or Request a Quote for your next project.