Vesta Announces New Class 10000 Clean Room
for Stringent Manufacturing Requirements
FRANKLIN, Wis. (Sept 1, 2011) — Vesta, a global leader in silicone and thermoplastic contract manufacturing services for medical device manufacturers, is pleased to announce a new, Class 10000 clean room. Located at Vesta’s ISO 13485:2003 registered silicone manufacturing facility in Franklin, Wis., the Class 10000 clean room will enable lower-particulate medical manufacturing that meets clients’ most stringent product standards.
“While the majority of our customers’ requirements can be supported in our Class 100000 controlled room environment for medical device manufacturing,” said Jim Fitzgerald, executive VP of Sales and Marketing at Vesta, “our additional certified Class 10000 clean room provides an environment with higher particulate air filtration to meet very strict requirements for those customers who require it for compliance with their product manufacturing specifications.”
Like Vesta’s existing Class 100000 clean room, the Class 10000 features a HEPA filtration system, temperature and humidity controls, as well as strict compliance with gowning procedures. The new clean room will be utilized for silicone molding, silicone extrusion, secondary operations, sub-assembly and packaging processes that require a maximum of 10000 particles (0.5 microns or larger) per cubic foot of air.
“Our greatest priority is delivering quality compliance at every step of the manufacturing process,” said Fitzgerald. “The new Class 10000 clean room is part of our commitment to helping our customers meet their specific quality requirements for their medical devices.”
To learn more, or to request a quote, visit www.vestainc.com
View the Class 10000 Certificate »
Vesta is an ISO 13485 certified medical device contract manufacturer providing silicone molding, silicone extrusion, thermoplastic extrusion and medical device assembly services. Vesta is recognized for its expertise in medical device design assistance, material selection and compliance to quality standards for optimal medical product development. Molding capabilities include liquid injection, transfer and insert molding of medical silicone. Vesta’s precision solutions utilize thermoplastics and silicone for a wide range of tight-tolerance extrusion applications, with special capabilities in heat shrink tubing, PEEK™ tubing and wound drains. Vesta capitalizes on 40 years of experience in helping the top global innovators launch their products with success. Find more information about medical device outsourcing with Vesta at www.vestainc.com