Medical Device Molding

Distinctive Plastics (DPI) specializes in injection molding for medical device manufacturers, offering our expertise in precision plastic molding and Clean Room manufacturing to meet the needs of this highly regulated market. We work with all major thermoplastics commonly found in the medical device and healthcare industries,

Clean Room Medical Device Molding at DPI

DPI offers Class 8 Clean Room work stations for medical device molding projects. These molding and handling areas are controlled with HEPA filtered, positive airflow to maintain the environment within the space. Several of our machines, including a variety of two-shot molding machines, are outfitted specifically for clean operations with all units certified up to Class 8 regulations. The exteriors of these machines always remain within the White Room environment , ensuring that all maintenance and adjustments are made without violating the Clean room seal.

In a traditional injection molding Clean Room, in order to bring any new mold tooling into the environment, manufacturers would be forced to open the room and allow unfiltered air in along with the tooling, violating the entire environment of all processes. At DPI, we make sure to quickly change the mold within the environment, without exposing the neighboring machines to unfiltered air. This ensures that other processes can proceed uncompromised, and streamlines the filtering process as we only need to readjust the machine being changed.

Maintaining Strict Compliance with Medical Industry Standards

Distinctive Plastics, Inc. maintains a quality management system certified to the standards set out in ISO 13485:2016 for plastic medical device molding, manufacturing, and engineering for the Medical Device and Equipment manufacturing sectors. We adhere to these standards for Clean Room and non Clean Room injection molding for the industry. Please get in touch if you would like to request our updated certificate.

Ready to get started?

Distinctive Plastics, Inc. (DPI) specializes in complex injection molding services for industries such as medical device manufacturing, where quality and precision are of the utmost importance. If you are interested in partnering with us, or if you have any questions, please contact us today to request a quote or more information.