Maintaining sterility is a costly process for drug manufacturers, but US company Pall Corp says it has introduced a new device that will allow biopharmaceutical producers to make aseptic connections instantly, reaping large savings in time, money and regulatory compliance.

The new Aseptic Connection Device connects converging fluid paths without compromising sterility and is claimed to be the only product of its type that does not require laminar flow hoods or other capital equipment to maintain sterility. It can be used at any time two pieces of flexible tubing need to be aseptically connected in an uncontrolled environment.

"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, labour and cost," said Ed Hoare, president of Pall BioPharmaceuticals.

Pall maintains that a major shift is taking place in the way the pharmaceutical industry manufactures drugs, with stainless steel production equipment being replaced by disposable products that do not need to be dismantled, cleaned and re-sterilized between batches.