MRPC Transitions Cleanroom at its Headquarters for Customer Program

Contract manufacturer MRPC recently transitioned one of its 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,” MRPC Sales/Marketing Vice President Jeff Miller said. “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 the company’s Butler, Wis., headquarters. 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, moving 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 and 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 program lifecycle.

“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,” Miller stated. “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 its medical device manufacturing capacity and is poised for growth and future opportunities. MRPC is currently expanding another cleanroom at its headquarters to accommodate additional automation, molding, and medical device assembly programs.

MRPC is a U.S. Food and Drug Administration-rRegistered, and ISO 13485 certified full contract manufacturer of medical devices, instruments, and disposables. With full range product lifecycle capabilities including design assistance, development, and manufacturing, MRPC is a turn-key manufacturing partner to some of the world’s largest medical device companies. Additionally, with thermoplastic, LSR, and rubber molding capabilities, clean room assembly and packaging, sterilization management and supply chain development, MRPC provides a range of capabilities and flexibility to the medical device industry.