Thermoformed medical device packaging

Custom thermoformed packaging for medical device companies and their supply chain partners, with in-house design, tooling, thermoforming, and ISO Class 8 cleanroom manufacturing

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Cleanroom thermoforming of medical packaging

thermoformed medical packaging

Custom thermoformed packaging for medical devices

Medical device manufacturers use custom thermoformed packaging to protect devices and support requirements for handling, distribution, storage, sterilization, and point of use. Applications include medical device trays for protective and sterile barrier packaging, surgical and procedural kits, cleanroom handling trays, and medical blisters for smaller devices.

Medical packaging requirements vary according to device geometry, intended use, cleanliness requirements, and whether a sterile barrier system is needed. Package design and material selection must account for device protection, sterilization compatibility, manufacturability, and aseptic presentation where applicable. Quality requirements, including dimensional inspection, traceability, and process validation, are established based on the application and customer specifications.

Medical Device Trays

Custom thermoformed trays engineered to protect, locate, and retain medical devices while supporting sterilization, secure handling, distribution, and point-of-use presentation

Surgical & Procedural Kits

Thermoformed trays that organize medical devices and components for assembly, sterilization, and clinical use

Medical Handling Trays

Thermoformed trays for cleanroom handling, assembly, inspection, and internal product movement

Medical Blisters

Custom thermoformed blisters for smaller, lightweight medical devices and components, designed for protection, visibility, and efficient presentation

our process

Packaging development process

Medical packaging development begins with understanding the application. Customers work with an experienced Dordan sales engineer to define device, packaging, sterilization, manufacturing, and performance requirements.

Before formal engineering begins, the project undergoes an engineering review followed by a cross-functional review with Quality and Production to identify potential manufacturing risks, quality concerns, and failure points.

Dordan then prepares an engineering report summarizing the proposed design approach, outstanding questions, and information needed before formal package design begins. Following customer review, engineering drawings are developed for approval, followed by prototypes, production tooling, and thermoforming.

Application and packaging requirements review
Engineering and cross-functional risk review
Engineering report and customer review
Engineering drawings for customer approval
Prototype development and evaluation
Production tooling and thermoforming
First article inspection (FAI), first article validation (FAV), and process capability (Cpk) studies
Full process validation (IQ/OQ/PQ), as required by customer and project specifications

Design & Engineering

Custom medical packaging is designed in Siemens NX around device geometry, package performance, manufacturing requirements, and the thermoforming process. Engineering drawings and project-specific engineering reports document critical dimensions, design requirements, manufacturability, and forming considerations before tooling development.

Tooling & Prototyping

Prototype and production tooling is CNC-machined in-house from aluminum using NX CAM. Prototype tooling supports sample development and customer review before production tooling is finalized, helping verify package dimensions, fit, function, and manufacturability early in development.

Cleanroom Manufacturing

Medical packaging is thermoformed in Dordan’s ISO Class 8 cleanroom on dedicated equipment for medical packaging production. In-house cleanroom manufacturing supports controlled, repeatable production using approved tooling and documented manufacturing processes.

Quality & Validation

Medical packaging production is supported by Dordan’s ISO 13485:2016 and ISO 9001:2015-certified quality management systems. Quality controls include first article inspection, first article validation, with process validation and Cpk capability studies available upon request.

Cleanroom & quality

Medical packaging cleanroom thermoforming

Dordan operates a 3,200-square-foot, hard-wall ISO Class 8 cleanroom for medical device packaging manufacturing. 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 risks associated with bioburden and microbial contaminants throughout cleanroom manufacturing.

Cleanroom production operates under Dordan's ISO 13485:2016-certified quality management system. Documented inspection, quality control, and validation procedures support compliance with customer specifications and project-specific packaging requirements throughout manufacturing.

Dordan conducts first article inspection (FAI) and first article validation (FAV) to verify critical tray dimensions and packaging specifications, incorporating process capability (Cpk) studies as applicable.

For projects requiring full process validation, Dordan performs installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) studies in accordance with customer and project requirements.