Second time's twice as nice: AdvantaPure expands cleanroom manfacturing again

Demand for silicone molded products has increased for one molder, resulting in a major expansion of their production capabilities. More and more pharmaceutical companies are adopting single-use systems for their products to ensure manufacturing safety, thus increasing the demand for AdvantaPure's brand of silicone container closures, BioClosure Systems. As a result, AdvantaPure expanded its cleanroom manufacturing facility 18 months ago, and just completed a second expansion.

AdvantaPure is a division of NewAge Industries that specializes in ultraclean thermoplastic and thermoset tubing, hose, and fitting products for the pharmaceutical, biomedical, food, beverage, and chemical industries.

The company converted space and moved some of its manufacturing operations to other areas in its building, and increased its production capabilities. The transformed areas now house stations for the manufacturing of single-use silicone manifolds and the BioClosure Systems.

Ken Baker, CEO of AdvantaPure, stated, "When we expanded in 2008 we thought the size of the facility would suit us for a number of years. But the industry's conversion to single use has really taken off. It was absolutely necessary to expand again to meet the demands—both current and anticipated—of our customers."

A couple of the reasons for converting to single-use in the pharmaceutical and biopharmaceutical manufacturing industry include the elimination of the rigorous and extensive cleaning process the stainless steel piping must undergo between each batch of pharmaceutical product. FDA cleaning regulations and procedural validations of procedures to reuse that piping are also extensive, said a company spokesperson. Single-use piping also reduces the chance of contamination that might occur in another batch of pharmaceuticals, causing the company to lose millions of dollars in product.

Using AdvantaPure piping also enables the manufacturer to do faster changeovers at the manufacturing facility when making a process change. Rather than installing stainless steel piping that needs to go through walls, the single-use piping means that it's more flexible and requires less manpower to route.

AdvantaPure repurposed its hose assembly area into a new cleanroom. The space now has HEPA filtration, sealed doors, gowning rooms, and restricted personnel usage. The cleanroom is third-party certified ISO Class 7 (Class 10,000). Former office space at AdvantaPure's building is currently under construction for additional cleanrooms. More manifold production stations are in the works, and the company is hiring more team members to meet manufacturing goals and satisfy customers.

The company expects orders for single-use systems and Bioclosure Systems to continue to grow. It offers manifolds consisting of tubing and/or reinforced hose; fittings in T, cross, Y, and reducer styles; and additional components such as filters, bags, and aseptic connectors. BioClosure silicone stoppers, True Union and GL45 inserts, and caps are manufactured for containers of glass, plastic, or metal and are available solid or with tubing inserts.

In business since 1954, NewAge Industries manufactures and fabricates thermoplastic and thermoset tubing and hose. The company offers one of the broadest product lines of tubing, hose, and fittings in the U.S., and also provides custom extrusion and fabrication services. NewAge Industries is an ESOP company since 2006.