A supplier of medical design, manufacturing and testing services, Evergreen Medical Technologies (St. Paul, MN) has announced the addition of nearly 4,000 square feet of cleanroom space to its current cleanroom facilities for the development and manufacture of next-generation implantable medical devices. Evergreen now maintains a total of more than 5,000 square feet of ultra-clean medical device manufacturing capacity.
The company added 1,300 square feet of ISO Class 8 microbial-controlled cleanroom space for critical manufacturing of acute use medical devices requiring particulate and microbial control. The new facility will be used for the fabrication of medical devices including EP catheters, angioplasty catheters, renal denervation catheters, guidewires and other acute medical devices.
Evergreen also added a 2,600-square-foot, ISO Class 7 cleanroom for microelectronics assembly and production of implantable medical devices. These include pacemakers, defibrillators, neurostimulator leads, implantable pulse generators, LVAD controllers and pumps, implant tools and other chronic medical devices.
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“The installation of these expanded cleanroom facilities is a major milestone in our goal to be a premier manufacturer of implantable medical devices that meet a wide range of clinical needs,” said Randy Nelson, CEO, in a prepared statement. “The combination of our deep understanding of clinical conditions, combined with our engineering expertise and state-of-the-art facilities, gives us a full spectrum of product development resources for medical device clients.
“This is particularly important for the latest generation of medical microelectronic technologies designed for permanent implantation in the human body,” continued Nelson. Post-manufacturing sterilization is not enough, he added: “They must be manufactured in a microbial-controlled environment, such as our new Class 7 cleanroom facility, to minimize the bioburden of pyrogenic substances that may remain and pose risks to the patient after a device is implanted.”