Dordan Manufacturing is a trusted supplier in the medical packaging market, offering 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 trays are engineered to prevent movement, abrasion, and contamination, ensuring safe delivery from manufacturer to end user.
Ease of Use: Trays are custom-designed for intuitive loading and opening, supporting aseptic presentation in clinical settings.
Regulatory Compliance: Thermoformed packaging is validated to meet ISO 11607 and other 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.
Protect, orient, sterilize, and streamline procedures with Dordan’s custom medical packaging:
Sealed with Tyvek® or other lidstock
Maintain device sterility and structural integrity
Improve operational efficiency for healthcare providers
Organize instruments and components intuitively
Package medical devices, instruments, and injectables
Designed for protection, cleanliness, and usability
Paired with aluminum or multi-laminate backings
Secure pharmaceuticals and FDA-regulated substances
Support contract manufacturing, staging, and shipping
Designed for automated or manual handling during assembly
From concept development through cleanroom manufacturing, our vertically integrated model ensures speed, quality, and control at every step of the process—critical for meeting the demands of the medical device industry.
Medical Package Design: We work closely with your team to design thermoformed trays that meet functional, regulatory, and usability requirements. Our design process includes 3D modeling, device interaction planning, and fast-turn prototyping for usability and fit validation.
In-House Tooling Fabrication: All production tooling is manufactured in our on-site tool shop, allowing for tight tolerances, immediate revisions, and rapid scale-up from prototype to production. We specialize in cleanroom-ready tooling with syntactic foam plug assists, matched metal dies, and heated cut stations.
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.
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.
Material Selection & Regulatory Support: We source and process a wide range of medical-grade materials, including PETG, HIPS, HDPE, and barrier-grade resins. Our team supports documentation requirements including biocompatibility, lot traceability, and regulatory compliance.
We understand the critical importance of maintaining sterility and minimizing contamination in medical packaging. Our in-house, ISO Class 8 certified cleanroom is specifically designed to meet the stringent requirements of the medical device industry, ensuring that every product we manufacture upholds the highest standards of cleanliness and quality.
Above: Dordan's ISO Class 8 cleanroom for manufacturing medical packaging
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 components, 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 weekly 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.
Dordan's commitment to quality is reflected in our certifications and quality control processes:
ISO Certifications: We are certified to ISO 9001:2015 and ISO 13485:2016 standards, underscoring our dedication to quality management and medical device packaging compliance.
Process Validation: Our quality assurance protocols include First Article Inspections (FAI), First Article Validations (FAV), and full process validations (IQ, OQ, PQ) to ensure consistent product quality.
Automated Optical Inspection: We utilize automated optical inspection systems for real-time quality verification, enabling us to maintain tight tolerances and high process capability indices (CPK).
Traceability and Documentation: Our quality management system ensures complete traceability of materials and processes, providing comprehensive documentation for regulatory compliance and customer assurance.
Dordan Manufacturing is a trusted provider of custom thermoformed medical packaging, delivering precision, compliance, and performance across every phase of development and production.
What Sets Us Apart:
ISO 13485 Certified Medical Packaging Manufacturer
ISO Class 8 Cleanroom Thermoforming
In-House Design, Tooling & Production
Production-Intent Prototyping
Cleanroom-Ready Material Selection
Validation & Quality Documentation
4th-Generation Family-Owned, Made in USA
Contact Us
Whether you’re launching a new device or scaling a global packaging program, Dordan is your trusted partner for high-performance medical packaging that meets every requirement. Contact Us or Request a Quote to discuss your medical packaging needs with our expert engineering and quality team.