Medical blister packaging
Custom thermoformed medical blisters engineered around your device and manufactured in-house for medical packaging applications
Lightweight protection for medical devices
Thermoformed medical blisters provide a compact packaging solution for smaller medical devices and components. Designed for applications where a more substantial medical tray may not be necessary, blister packaging can accommodate device-specific cavities, sealing requirements, and features that support product protection, visibility, and access.
Medical blister packaging can incorporate:
- Custom-formed cavities designed around product shape and dimensions
- Seal-flange geometry for compatible medical lidding systems
- Formed features for product protection, retention, and access
- Medical-grade PETG for product visibility
Engineering, tooling, and thermoforming
From blister design to cleanroom manufacturing
Dordan brings medical blister design, precision tooling, and cleanroom thermoforming together under one roof. This integrated approach helps streamline development, coordinate manufacturing requirements, and support a consistent transition from prototype to production.
Blister Design & Engineering
Medical blisters are designed in Siemens NX around device geometry, protection, access, and sealing requirements. Engineering considers cavity design, material distribution, seal-flange dimensions, and manufacturability before tooling begins.
Prototyping & Production Tooling
Prototype and production aluminum tooling is CNC-machined in-house using NX CAM. Prototype tools support sample development, design evaluation, and refinement of blister geometry before production tooling is finalized.
Cleanroom Thermoforming
Medical blisters are manufactured using dedicated thermoforming equipment within Dordan's ISO Class 8 cleanroom. Controlled production conditions support consistent forming for medical packaging applications.
Quality Control & Validation
Dordan's quality assurance processes support dimensional accuracy, manufacturing consistency, and compliance with customer specifications. Inspection, process capability studies, and validation activities are tailored to program requirements.
Medical blister cleanroom manufacturing & quality control
Dordan manufactures medical blister packaging in its 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 throughout production. Documented standard operating procedures support contamination control, including measures to minimize particulate contamination and manage bioburden risks.
Medical blister packaging is manufactured under Dordan's ISO 13485:2016-certified quality management system. First Article Inspection (FAI) verifies critical dimensions and package requirements, while First Article Validation (FAV) evaluates manufacturing consistency and process capability through Cpk studies.
For lidded medical blisters, consistent material distribution and seal-flange dimensions are important to support repeatable sealing surfaces and finished package integrity. Additional process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), is available based on customer and project requirements.
Custom medical blister packaging for your application
From design and prototyping through cleanroom production, Dordan develops custom thermoformed medical blisters tailored to your device and packaging requirements. Share your project details, even if your specifications aren't finalized. Our team will respond the same business day.