国外隔离器相关报道

水草

Barrier isolators and restricted-access barrier systems (RABS) are the future of parenteral filling, and it will be essential for pharmaceutical manufacturers to understand the benefits and costs of using each type in the coming years, members of a Parenteral Drug Association (PDA; Bethesda, MD) committee agreed at PDA's annual meeting, held December 3, 2001, in Washington, DC.

Barrier isolators enclose the filling system entirely and do not require cleanrooms; RABS systems are essentially isolators without bottoms and must be placed in a cleanroom. It has been shown that, if used properly, they can achieve the same results as an isolator, but with less up-front cost.

Consultant Dmitri Wirchansky of Jacobs Engineering Group Inc. (Conshohocken, PA), leader of PDA's Isolation Technology Interest Group, told group members during the meeting that he envisions that all firms will eventually choose between isolators and RABS.

"I don't think the traditional cleanroom approach will be the right thing to do in today's regulatory environment," he said. "And if you build a plant now, you have to try to predict what the regulatory requirements will be 10 or 15 years down the road."

RABS may be better suited for use with older, more "closed" equipment that was not designed for use in isolators, members said. And, several of them added, the assumption that isolators are more difficult to validate may no longer be true, as a number of firms have successfully demonstrated how to validate isolators, and getting reproducible results in the cleaning and sanitizing of RABS may not always be easy.

However, Richard Friedman, a compliance officer with FDA's Center for Drug Evaluation and Research, told the group that, because its inspectors are more familiar with the technology, the agency has been giving isolators the benefit of the doubt when it comes to evaluating sterility assurance.

The agency sees advantages to using isolators, especially now that they can accommodate higher-speed lines than they used to, but encourages RABS for firms that do not want to invest in isolators, Friedman said. Even then, he said, recent studies have shown that "after three or four years of using an isolator, it is making you money," whereas RABS "may not afford the [long-term] economic benefit that comes along with isolators."