The AdvantaPure division of NewAge Industries Inc. rapidly is expanding its capabilities by building another clean room, and plans to add more in the near future.
The company recently completed construction of a Class 10,000 clean room at its Southampton plant, the second added at the site in the last year and a half. It also brought in new equipment. The cost of the expansion wasn't released.
Additional clean room production operations at the facility are needed to keep pace with customers' adoption of single-use systems in pharmaceutical and biopharmaceutical products, according to Ann Phy, marketing coordinator for the company.
Orders for those products have been increasing at a fast pace, she said.
We definitely see this as an area of continuing growth, she said.
A third expansion to create more clean rooms is under way, but a completion date for the project hasn't been determined.
Southampton-based AdvantaPure moved its hose assembly unit to vacant space in the facility and converted that area for the Class 10,000 clean room, Phy said.
The new room is used primarily for inspection, she said, and the company filled it with light tables, magnifying devices for close inspection, storage racks, and tables and equipment for product packaging.
The clean room atmosphere is important, though, because the items coming in are not packaged until after inspection, she said. We double bag most of our single-use systems for cleanliness. Experienced workers are handling the inspection jobs, but we are hiring in other areas, namely our molding operations.
Phy said the clean room is restricted to essential personnel only. Workers entering the room must first go through a gowning area and don full coveralls, boots, head and beard coverings, and gloves.
Single-use systems are used primarily in the pharmaceutical industry for drug sampling and manufacturing applications, she said. Their popularity has been growing steadily due to concerns over contamination risks with cleared and reused products, such as stainless-steel pipe systems; their speed for product changeovers flexible tubing is easier to maneuver than systems of hard pipe; and regulations from the [Food and Drug Administration] regarding the validation of cleaning procedures.
With single-use systems, validation concerns are eliminated because the product is thrown away after one use, Phy said.
In December 2008, AdvantaPure spent about $200,000 to build a 2,700-square-foot Class 100,000 clean room used to produce silicone manifolds. The firm also added work tables, storage areas, and a research-and-development section.
When we expanded in 2008, we thought the size of the facility would suit us for a number of years, CEO Ken Baker said. 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.
The firm offers manifolds consisting of tubing and/or reinforced hose; fittings in T, cross, Y and reducer styles; and additional components. It also produces BioClosure-brand silicone stoppers, True Union and GL45 inserts, and caps for containers.
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