Dordan is a full service medical thermoforming company with in house packaging design, tooling, and ISO Class 8 Cleanroom manufacturing. This integration between engineering and thermoforming allows for the development of high-quality medical packaging that meets the safety and regulatory requirements for medical device manufacturers worldwide.
DORDAN'S IN-HOUSE MEDICAL PACKAGING DESIGN & TOOLING CAPABILITIES
NX Solid Modeling
NX design and CAM/CNC tooling integration
3 CNC Hass machining centers that run 24/7
3D-printed and formed prototypes
CNC-machined prototype aluminum tooling and prototypes
Cleanroom Tooling with custom components like syntactic foam plug assists and heated dies
Final Production Drawing with critical dimensions and tolerances (at a CPK of 1.33).
DORDAN'S CLEANROOM THERMOFORMING & QUALITY CONTROL
Dordan’s in house ISO Class 8 Cleanroom is a controlled environment that produces high quality medical packaging through execution of the standards of its ISO 9001:2015 and ISO 13485:2016 Certified Quality Management System.
DORDAN'S CLEANROOM FEATURES
ISO Class 8 Cleanroom meeting ISO 14644 Air Cleanliness Standards
3,200 sq. ft. fully enclosed and complete hardwall construction
Keife thermoforming machines
Cleanroom Tooling with custom components like syntactic foam plug assists and heated cutting dies
Cascading filtered airflow design minimizes the presence of airborne particulate
Separate gowning and material entry rooms
Daily particulate count readings
Pre-production and post production deep clean with intermediate cleanings
Sterilization via dry fogging
Dordan's ISO Class 8 Cleanroom for manufacturing medical packaging
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- DORDAN'S QUALITY CONTROL CAPABILITIES
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First Article Inspection, First Article Validation, Full Process Validations, PPAPs
Final Production Drawing with tolerances (at a CPK of 1.33)
ABOUT US
Dordan is a third-generation, family-owned and operated thermoformer of custom medical packaging solutions like medical device trays and blisters, procedural kits and containers, and assembly trays. The 62-year-old thermoforming company is based outside Chicago, IL. and specializes in applying six-decades of custom thermoforming experience to the development of high-quality medical packaging solutions.
