Dordan Manufacturing specializes in custom medical clamshell packaging manufactured in or out of an ISO Class 8 certified cleanroom. As a fourth-generation, family-owned company with over 62 years of experience, we manufacture thermoformed medical clamshells engineered for safety, sterility, and workflow efficiency.
Certified to ISO 13485:2016 and ISO 9001:2015, Dordan provides in-house design, tooling, plastics thermoforming, and cleanroom manufacturing to ensure every medical clamshell we produce meets the most demanding industry standards.
Medical clamshells are durable, rigid plastic packaging solutions designed to protect, orient, and organize medical devices from fulfillment through end use.
Thermoformed For Precision, These Trays:
Provide a secure barrier for delicate instruments and components
Support efficient sterilization when placed in a Tyvek® pouch
Enhance operational efficiency in hospital and surgical environments
Offer easy, intuitive device removal with engineered finger access
Sterile Barrier Compatibility: When sealed in a Tyvek® pouch, medical clamshells can act as a sterile barrier system. Built-in channels allow for ETO sterilant penetration throughout the device cavity.
Custom Fit & Secure Orientation: Designed with press-fit and friction-fit features to secure components and maintain proper device positioning during shipping, storage, and use.
Efficient Storage & Handling: Compact and stackable designs minimize hospital storage space. Clamshells can also be configured with drop cavities, allowing products to be released into a sterile field upon opening.
Multi-Component Packaging: One clamshell can accommodate multiple medical devices or components, simplifying procedural workflows and reducing secondary packaging needs.
As a fully integrated thermoformer, Dordan provides complete medical clamshell packaging development under one roof:
Siemens NX CAD Design: Precise modeling and validation of thermoformed clamshells based on device geometry
In-House CNC Tooling: Prototype and production tools are machined by the same engineers who design your clamshell
Plastics Thermoforming: Standard production facility houses 11 in-line thin gauge thermoforming machines for less-critical medical clamshell packaging applications
ISO Class 8 Cleanroom Thermoforming: Our hardwall cleanroom controls particulate and bioburden to maintain product cleanliness and efficacy
ISO 9001:2015 and ISO 13485:2016 certified QMS
This integration allows for quick turnarounds, cost-effective solutions, and superior product quality from concept to production.
Medical Device Manufacturers: We design clamshells for single-use and reusable medical devices, such as syringes, surgical instruments, and diagnostic equipment—offering protection, sterility, and intuitive product access.
Contract Manufacturers & Assemblers: Dordan supplies cleanroom-compatible medical clamshells used in device kitting, packaging, and fulfillment. Features like press-fit cavities and ETO-compatible design support automation and compliance needs.
Pharmaceutical & Biotech Companies: Our clamshells help organize and protect components for diagnostic kits, drug delivery systems, and clinical trial packaging—maintaining product integrity and user confidence.
Dental & Specialty Care Providers: From orthodontic trays to instrument clamshells, our packaging ensures hygiene, clarity, and reliable performance for niche medical and dental products.
At Dordan Manufacturing, we operate a state-of-the-art, fully enclosed ISO Class 8 cleanroom specifically designed for the production of thermoformed medical packaging. This controlled environment ensures the highest levels of cleanliness and sterility, critical for medical applications.
Key Cleanroom Features:
Advanced Equipment: Our cleanroom houses Keifel Speedformers equipped with automated forming, cutting, stripping, and stacking capabilities, ensuring precision and efficiency.
Environmental Controls: The facility maintains strict particulate and bioburden control, with weekly particulate counts and quarterly environmental risk assessments to comply with ISO 14644 standards.
Sterilization Protocols: We employ dry fogging sterilization processes and use FDA-certified cleaning agents to maintain a contaminant-free environment.
Material Handling: Dedicated gowning and material staging areas with controlled air pressure zones prevent cross-contamination during the manufacturing process.
Our cleanroom capabilities enable us to produce medical clamshells that meet stringent regulatory requirements, ensuring product safety and integrity from production to end-use.
Quality is at the core of Dordan's operations. Our Quality Management System is certified to both ISO 9001:2015 and ISO 13485:2016 standards, reflecting our commitment to excellence in medical packaging.
Our Quality Assurance Process Includes:
Risk-Based Management: We conduct thorough risk assessments during the design and manufacturing phases to identify and mitigate potential issues, ensuring product reliability and compliance.
In-Process Monitoring: Utilizing real-time CPK (Process Capability Index) analysis, we monitor production processes to maintain consistent quality and adherence to specifications.
Comprehensive Inspections: Our quality control procedures encompass incoming material inspections, first article inspections, and equipment readiness checks to uphold the highest standards.
Documentation and Traceability: We maintain detailed records for every product batch, facilitating traceability and accountability throughout the production lifecycle.
By integrating these rigorous quality assurance measures, Dordan ensures that every medical clamshell package we produce meets the exacting demands of the healthcare industry.
When it comes to custom medical clamshell packaging, choosing the right partner is critical to ensuring patient safety, product integrity, and regulatory compliance.
What Sets Us Apart:
Medical Clamshell Packaging Design Expertise
Cleanroom Thermoforming
Quality from Start to Finish
Family-Owned Accountability Since 1962
Speed & Flexibility, Made in USA
Need a reliable partner for custom medical clamshells or thermoformed sterile barrier packaging? Contact Us or Request a Quote today to start your next project with Dordan.