MRPC Transitions Cleanroom to ISO 7 In Support Of New Customer Program

MRPC, a fully integrated contract manufacturer of medical device assemblies and components, recently transitioned one of their cleanrooms from ISO 8 to ISO 7 in support of a new customer program.

The extensive project was initiated to support a customer’s implantable component program requirements. The surgical implantable requires multiple molding operations and sub-assembly in an ISO 7 cleanroom, which has more stringent air filtration parameters than an ISO 8 cleanroom.

“MRPC believes in the importance of building long-term partnerships with our customers, including investing in our business to support new customer initiatives”, said Jeff Miller, Vice President of Sales & Marketing at MRPC. “This program aligns well with our core competencies, and our approach to adapting and investing in our facilities, equipment and team to support customer requirements and needs.”

The newly transitioned ISO 7 cleanroom is located in one of the manufacturing buildings at their Headquarters location in Butler, WI. The build-out included capital investments to meet the client’s need. Converting the cleanroom to ISO 7 included enhancements to the HVAC system, adding a high-efficiency particulate air (HEPA) filtration system and ductwork to increase air exchanges, new ceiling and flooring, movement of molding machines and cleanroom testing and certification. While this stage took several months, the planning behind the build-out began in early 2024.

The cleanroom is equipped with multiple injection molding machines, as well as a medical device assembly area. Finished medical device assembly is a core competency of MRPC and includes device assembly, packaging, and sterilization management of finished medical devices. These types of services are leveraged by multiple MRPC customers and offer more control over the lifecycle of the program.

“In addition to being able to support the program requirements for our current customers, this cleanroom transition sets MRPC up for future growth with other customers”, said Miller. “We’re continuing to convert and expand more existing space into cleanroom space to support our customers and the overarching business initiative of being a world class medical device manufacturing partner.”

As a result of this cleanroom transition project, MRPC has increased their medical device manufacturing capacity and is poised for growth and future opportunities. MRPC is in the process of expanding another cleanroom at their Headquarters location to accommodate additional automation, molding and medical device assembly programs.