APRIL 4–EAST HILLS, N.Y.–Maintaining sterility is a costly process for drug manufacturers, and Pall Corp. says biopharmaceutical producers can make aseptic connections instantly and reap large savings in time, money and regulatory compliance.

Pall’s new Aseptic Connection Device (ACD) connects converging fluid paths without compromising sterility and does not require laminar flow hoods.

A major shift is taking place in the way the pharmaceutical industry manufactures drugs. Stainless steel production equipment, long the industry standard, is being replaced by disposable products that do not need to be dismantled, cleaned and resterilized between batches.

“FDA scrutiny of drug development practices and increasing competition to bring new drugs to market faster created the need for a connection device that provides greater sterility assurance and saves time, labor and cost,” said Ed Hoare, president of Pall BioPharmaceuticals. “

The Pall ACD is used any time two pieces of flexible tubing need to be aseptically connected in an uncontrolled environment. Its use at critical junctures throughout biopharmaceutical processing speeds the formation of aseptic connections from starting fluid to purified product. Compared to traditional connection methods, such as tubing welders and quick connectors, the device shortens the time it takes to create aseptic connections from 15 minutes to seconds. The disposable device promotes efficient manufacturing practices that eliminate the need for cleaning and cleaning validation.

Citing “rigorous validation tests,” the company says the ACD “ensures the safety and integrity of aseptic connections and eliminates prospects for malfunction of laminar flow hoods and tubing welders.”

The ACD’s also provides venting that allows steam to penetrate and prevents tubing from collapsing after autoclaving. It also eliminates the need for a large amount of space, and maintenance of equipment documentation, which is required for laminar flow hoods and tubing welders.