Dordan's 2019 fully-enclosed and complete hardwall construction ISO Class 8 Cleanroom produces sterile and non-sterile thermoformed medical device packaging for FDA Class I, II, and III devices, instruments, and procedural operations.
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 is ISO 13485 pursuant, developing robust, standalone quality control procedures. With 60-years custom thermoforming, Dordan applies its thermoform design and manufacturing excellence to the production of high-quality and highly-engineered thermoformed medical device packaging solutions.
Thermoformed medical device trays with Tyvek or other-substrate lidding for sterile and non-sterile medical devices and instruments protect and maintain device safety and cleanliness.
Procedural, surgical, and diagnostic thermoformed insert trays for medical kits facilitate intuitive product use by practitioners.
Thermoformed medical clamshells protect and maintain the safety and cleanliness of medical instruments, devices, syringes, and injectionables.
Thermoformed medical dunnage trays offer medical device assembly, manufacturing, and distribution efficiencies.
Thermoformed medical components meet specific functional requirements for medical device assembly, manufacture, distribution, or use.
Kiefel Speedformer for ISO Class 8 Cleanroom