Evergreen Medical Technologies expands cleanroom facilities

Medical devices and systems developer, Evergreen Medical Technologies, has announced the expansion of its current cleanroom facilities to assist with the development and manufacturing of next-generation implantable medical devices.

In total, the company has added nearly 4,000 square feet of advanced technology cleanroom space.

The expansion will allow Evergreen to produce a range of implantable medical devices, microelectronics and medical devices requiring particulate and microbial control.  

Evergreen added 1,3000 square feet of ISO Class 8 microbial-controlled cleanroom space for critical manufacturing of acute use medical devices. This facility will be used for production operations of medical devices including EP catheters, angioplasty catheters, renal denervation catheters, guidewires, and other acute medical devices.

The company also added a new 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.

Randy Nelson, CEO of Evergreen Medical Technologies said: “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. 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. For these most sophisticated devices, post-manufacturing sterilisation is not enough. They must be manufactured in a microbial-controlled environment, such as our new Class 7 clean room facility, to minimise the bioburden of pyrogenic substances that may remain and pose risks to the patient after a device is implanted.

“Our expanded facilities allow us to offer device developers a complete production solution for active implantable devices, from microelectronic component assembly to finished implantable device manufacturing. Having a high quality production facility in one location saves time, improves efficiency, and results in implantable devices of the highest quality and safety for our clients.” Concluded Nelson.