Dordan Manufacturing designs and manufactures medical clamshell packaging in or out of our ISO Class 8 certified cleanroom. Medical clamshells protect devices, and when placed in an outer pouch, offer sterility solutions.
Above: Medical clamshell packaging protects and keeps clean devices
As a fourth-generation, family-owned company with 63 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 is a fully integrated medical clamshell supplier with in house design, tooling, thermoforming, and cleanroom manufacturing.
Medical clamshells are durable, rigid plastic packaging solutions designed to protect, orient, and organize medical devices from fulfillment through end use.
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
Medical clamshells are used in both critical and non critical medical packaging applications.
Medical clamshell features include:
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.
Above: Non-sterile medical clamshell for dental instruments
As a fully integrated thermoformer, Dordan provides complete medical clamshell packaging development and production under one roof.
Our in house capabilities include:
Siemens NX CAD Design: Utilizing Siemens NX CAD for its designs, Dordan employs a risk-based approach with design for manufacturing principles, resulting in the production of high quality medical clamshell packaging. Dordan's package design process is governed by its ISO 9001:2015 and ISO 13485:2016 standards, which require extensive documentation, thorough review, and high functioning clamshell packaging designs.
NX CAD/CAM In-House CNC Tooling: Prototype and production tools are programmed by the same team of engineers who design the medical clamshell packaging, reducing translation errors. Prototype tooling is a 1-up of the production tool and is machined out of aluminum. Once the prototypes are approved, the geometry is replicated across the surface of the production tool via step and repeat, ensuring each cavity is identical to the next.
Plastics Thermoforming: 12 in-line thin gauge thermoforming machines for less-critical medical clamshell packaging applications. We offer a semi medical production control plan for medical clamshells that do not require cleanroom production, yet need a higher level of quality control than standard factory production.
ISO Class 8 Cleanroom Thermoforming: A fully enclosed and complete hardwall space, Dordan's cleanroom minimizes the level of particulate and bioburden agents in the production environment. This is ideal for medical clamshells that require production in a controlled environment.
ISO 9001:2015 and ISO 13485:2016 certified quality management system to ensure the clamshells being manufactured meet the standards for the on time delivery of defect free products.
Above: Cleanroom manufacturing of medical clamshells
63-Years of Custom Thermoforming Experience
Fully-Integrated Design & Manufacturing
ISO Class 8 Cleanroom | ISO 13485:2016 Certified
4th Generation Family-Owned Since 1962, Made in the USA