New ISO Class 7 and 8 cleanrooms are now in operation at the Southampton, PA, headquarters of NewAge Industries/AdvantaPure, the culmination of a $10-million investment and nearly two years of planning, preparation, construction and validation. The company is using the new space to produce platinum-cured silicone tubing, molded components and single-use molded tubing assemblies for the life sciences sector.
“This was a big undertaking,” said Ken Baker, CEO of the employee-owned business. “We needed additional cleanrooms to manufacture more high-purity tubing and components to meet our customers’ needs, but we didn’t want to add a random room next to our other cleanrooms. This new area was designed and built from the ground up, with a vetted product flow-through design for raw materials, extrusion, molding, quality inspection and packaging.”
The manufacturing suites and inspection areas total 23,000 square feet, with another 20,000 square feet renovated for additional warehouse space.
“Our intent was to move and validate our manufacturing equipment in phases to avoid any production stoppages or product shortages. We accomplished that, but we also decided to add more extrusion equipment and mold presses,” said Baker.
The AdvantaPure division of NewAge Industries is certified to ISO 9001:2015 and specializes in high-purity tubing, hose, single-use process tubing manifolds, BioClosure systems and other molded components. In addition to the pharmaceutical, biopharm and biomedical sectors, the company also serves the food, beverage and chemicals industries.