APEX, N.C.—Polyzen Inc., a custom, thin-wall manufacturer of components for medical devices, has expanded its clean room operations to include film extrusion in a Class 10,000 environment.
The project will support prototype development, scale-up and manufacturing of film for use in regulated medical devices, including wound care and implants.
“The clean room is a new, flexible system that sits within an existing room,” according to Rubin Shah, managing director of Polyzen. “We have upgraded our current line to satisfy our immediate customer needs. In addition, we are looking at adding additional capabilities and potentially another line as well. All this is driven by market needs and more specifically actual customer demand.”
The cost of the investment was not released. No employees were added; however, as the company's services expand, it will add staffing as needed.
Polyzen already has more than 8,000 square feet of Class 10,000 manufacturing area earmarked for other processes, Shah said.
“Our melt processing capabilities and extrusion lines have always been in a controlled environment production area, also known as white room,” he said. “Given our opportunity to supply companies with implantable grade or bioabsorbable films, we have chosen to convert our white room to a Class 10,000 area as well.”
Medical devices that present increased risk to patients or clinicians often require greater regulatory controls, Polyzen said, including clean room manufacturing.
It said these applications increasingly rely on specialty polymers, including bioresorbable polymers and fluoropolymers, for specific performance requirements.
“There are an increasing number of companies developing devices for implants and drug delivery applications. Many of these require clean room manufacturing,” Shah said.
Polyzen's new extrusion line is able to produce film up to 52 inches (132 centimeters) wide in thicknesses ranging from 0.0005 to 0.07 inches (0.0127 to 1.778 millimeters), he said, with in-line X-ray gauge dimensional reporting.
The new line is able to process various materials, including thermoplastic polyurethanes, thermoplastic elastomers, polyolefins, polyamides, fluoropolymers and bioresorbable polymers.
Polyzen said a 450-sq.-ft. clean room with high-efficiency particulate air filters encapsulates the extrusion line to allow for film processing of these materials in the Class 10,000 environment.
“Medical device companies are increasingly interested in working with qualified suppliers that can provide a larger breadth of services,” Shah said. “As such, increasing our service offering is a very important part of our strategic decision-making. Many of these services are aligned with the needs of product development engineers who are on the front end of medical device innovation. This investment allows us to offer development quantities of medical grade film in a clean room environment, and then scale it up for production.”
Polyzen also offers liquid processing to solid state processing.
The company's focus recently has been to expand its melt processing capabilities.
“As our customer demands continue to grow, we seek to grow with them,” he said. “This could include expansion of our current facilities in the future.”
For more information about Polyzen's clean room film extrusion services, visit www.polyzen.com.