Thermoformed medical device trays

Custom medical packaging trays designed to protect, organize, and maintain the integrity of medical devices throughout handling, distribution, and use

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medical packaging

Medical device tray packaging

Thermoformed medical device trays are rigid plastic packages designed to contain, protect, and organize medical devices during handling, distribution, storage, and point-of-use presentation. Depending on the application, trays can serve as part of a sterile barrier system or provide non-sterile protective packaging.

Dordan designs and manufactures custom thermoformed medical device trays for medical device OEMs and their supply chain partners. Each tray is developed around the device's dimensions, protection requirements, intended use, and applicable sterilization processes. Material selection and packaging design are evaluated to support device integrity, package cleanliness, and performance throughout distribution and use.

Medical device trays can support:

FDA Class I, II, and III medical devices
Complex device dimensions and critical features
Sterile and non-sterile packaging applications
Individual devices and multi-device configurations
Aseptic presentation and point-of-use device removal
Ethylene oxide (EtO), gamma irradiation, and electron beam (e-beam) sterilization compatibility, depending on material selection

Protection & Device Integrity

Medical trays provide structural protection to help maintain device safety during handling, distribution, sterilization, storage, and point of use. Tray design protects critical device features and reduces the risk of damage.

Device Retention & Orientation

Custom-formed cavities and retention features control device position and movement within the tray while supporting loading, handling, presentation, and point-of-use removal.

Material Distribution & Sealing

Controlled material distribution helps maintain consistent wall thickness and structural integrity throughout the thermoformed tray. Uniform seal-flange dimensions supports reliable sealing with compatible medical lid stock for sterile barrier applications.

Design & Engineering

Medical device trays are developed in Siemens NX around device dimensions, packaging requirements, and the thermoforming process. Engineering drawings and project-specific reports define critical dimensions, structural requirements, and material distribution before tooling begins.

CNC for producing medical packaging thermoform tooling

Medical Tray Thermoform Tooling

Prototype and production tooling is CNC-machined in-house from aluminum using NX CAM. Prototype tools allow for sample development, design evaluation, and customer approval before production tooling is finalized.

Medical Tray Cleanroom Thermoforming

Dordan manufactures medical device trays using dedicated thermoforming equipment within an ISO Class 8 cleanroom. Controlled manufacturing conditions support consistent production for medical packaging applications.

Thermoforming Quality Control & Validation

From initial dimensional inspection through process capability studies and validation, Dordan's quality assurance activities help ensure medical device trays meet customer specifications and production requirements.

cleanroom & quality control

Medical device tray cleanroom manufacturing & quality control

Dordan manufactures custom thermoformed medical device trays in a 3,200-square-foot, hard-wall ISO Class 8 cleanroom. Temperature, humidity, and airborne particulate levels are controlled and monitored to maintain specified manufacturing conditions.

Documented standard operating procedures support contamination control, including measures to manage and mitigate bioburden risks throughout medical tray production.

Manufacturing operates under Dordan's ISO 13485:2016-certified quality management system. First article inspection (FAI) and first article validation (FAV) verify critical tray dimensions and packaging requirements, with process capability (Cpk) studies incorporated as applicable.

For medical device tray programs requiring full process validation, Dordan supports installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) based on customer and project requirements.