Dordan's 2019 fully enclosed and complete hardwall construction ISO Class 8 Cleanroom thermoforms medical packaging solutions like medical device trays, medical clamshells and blisters, and surgical kits.
Dordan's cleanroom for manufacturing medical packaging
Dordan's cleanroom is fitted with 2019 Kiefel Speedformers equipped with best-in-class automated forming, cutting, and stripping stations. ISO 9001:2015 certified, Dordan offers customizable QC standards, including, but not limited to: first article validation procedures, small-volume validation runs, process validation procedures (IQ/OQ/PQ), and PPAPs. Dordan's cleanroom standard operating procedure strives to minimize, monitor, and manage the level of particulate as per ISO Class 8 Cleanroom requirements.
With 60-years custom thermoforming, Dordan applies its thermoform packaging design and manufacturing excellence to the production of high quality and highly-engineered thermoformed medical packaging solutions.
Medical device trays, sealed to Tyvek or other substrate lidding, protect and maintain medical device safety and sterility.
Thermformed surgical kits offer procedural efficiencies and workflow consistency for medical practitioners.
Thermoformed medical clamshells protect and maintain the safety and cleanliness of medical instruments, devices, syringes, and injectionables.
Thermoformed dunnage trays offer medical device assembly, manufacturing, and distribution solutions.
Thermoformed components meet specific functional requirements for medical device assembly, manufacture, distribution, and/or use.
QC inspects medical tray for compliance with customer's CPK target
Cleanroom Production Manager programs thermoformer