Dordan Manufacturing offers custom thermoformed medical packaging solutions for medical device OEM's and their supply chain partners worldwide. We combine ISO 13485:2016 and ISO 9001:2015 certified quality management systems with in-house design, tooling, thermoforming, and ISO Class 8 cleanroom manufacturing to deliver high-performing, regulation-compliant packaging solutions.
Thermoformed medical packaging is a highly engineered solution used to securely contain and protect medical devices throughout sterilization, shipping, storage, and point-of-use handling. These rigid plastic trays, kits, and blisters are custom-formed to fit the exact dimensions and functionality of the device, ensuring performance in both sterile and non-sterile environments.
Sterile Barrier Systems: Designed to be sealed with Tyvek®, film, or foil lidstock, these trays maintain sterility until the point of use—ideal for surgical kits, implants, and diagnostic devices.
Device Protection: Thermoformed packaging is engineered to prevent movement, abrasion, and contamination, ensuring safe delivery from manufacturer to end user.
Ease of Use: Medical trays and packaging are custom-designed for intuitive loading and opening, supporting aseptic presentation in clinical settings.
Regulatory Compliance: Thermoformed packaging is validated to meet industry standards, supporting FDA and EU MDR requirements for medical device packaging.
Custom Fit and Functionality: Every tray is tailored to the shape, weight, and handling needs of the device it protects, optimizing both workflow and safety.
From concept development through cleanroom manufacturing, our vertically integrated model ensures speed, quality, and control.
Medical Package Design: We work closely with your team to design thermoformed trays that meet functional, regulatory, and usability requirements. Our design process includes engineering drawings, 3D printed samples, 3D modeling, and prototypes.
In-House Tooling: All production tooling is manufactured in our on-site tool shop. We specialize in high-precision cleanroom tooling.
ISO Class 8 Cleanroom Thermoforming: We thermoform your packaging in a validated ISO Class 8 cleanroom, supporting sterile barrier system requirements and contamination-sensitive devices. The cleanroom features temperature and humidity control, cascading airflow, particle count monitoring, and routine deep cleaning.
ISO-Certified Quality Management: Our operations are ISO 13485:2016 and ISO 9001:2015 certified, with process validation, inspection protocols, and traceability systems designed for FDA- and MDR-regulated packaging programs.
Our in-house, ISO Class 8 certified cleanroom is designed to meet the stringent requirements of the medical device industry, ensuring that every product we manufacture upholds the standards for cleanliness and quality.
Cleanroom Features:
Fully Enclosed Hardwall Construction: Our cleanroom is a 3,200 sq. ft. facility with hardwall construction, providing a controlled environment that minimizes particulate and microbial contamination .
Advanced Thermoforming Equipment: Equipped with Keifel Speedformers, our cleanroom facilitates precise forming, cutting, stripping, and stacking of medical packaging, ensuring consistent quality and performance.
Air Quality Management: We maintain a positive air pressure differential between the cleanroom and adjacent areas, coupled with cascading filtered airflow, to prevent the ingress of contaminants.
Regular Monitoring and Cleaning: Our cleanroom undergoes random particulate count testing and is subject to rigorous cleaning protocols, including pre- and post-production deep cleaning and sterilization via dry fogging.
Gowning and Material Handling Procedures: We enforce strict gowning procedures and have dedicated material entry rooms to further reduce the risk of contamination.
ISO 13485 Certified
ISO Class 8 Cleanroom Thermoforming
In-House Design, Tooling & Production
Validation & Quality Documentation
4th-Generation Family-Owned & Made in USA