Disqualification, alert status, gowning focus of FDA audits.

PHILADELPHIA -- When it comes to clean rooms, FDA takes a hard look at disqualification, Anne Marie Dixon told an Institute for International Research (IIR) meeting on contamination control.

The inspector wants to know if the site is frequently in alert status. Do workers use poor gowning techniques during media fill? Why wasn't there requalification for three months. Why do tests show the presence of mold, fungus, yeast gram-negative rods or other organisms?

Building uniforms and scrubs are a big concern, according to Dixon, who is managing partner of Cleanroom Management Associates, Carson City, NV. She told the Oct. 21-22 meeting that many clean room workers change scrubs by first replacing the top, then the bottom.

"This is unacceptable, because the old scrubs touch the new ones," she said. It's better to forget modesty and remove the old scrubs entirely before donning the new ones."

Other concerns include plant suits that are delivered uncovered. Workers then store them in small lockers and don them in small rest rooms, both sites of possible contamination.

Dixon sees clean room workers themselves as the major source of contamination, especially those on second shift who report in by 2 p.m. "They've been everywhere outside the plant all morning and probably shouldn't even be in the facility by early evening," she said.

She takes a dim view of vendors wearing badges who have access to all facilities, because they lack GMP training.

Gowning a morale problem

Dixon said poor gowning and decontamination procedures can be partly attributable to morale problems in clean rooms.

She noted this is generally a dead-end job, with the average worker lasting only about six months. Some salaries are comparable to those at McDonald's, Dixon added. She advocated that manufacturers should consider skill-based pay instead and be cognizant of the stress of working in the clean room.

According to Dixon, many clean room workers do not know what they are working with. "It's just 'soup' to them," she argued.

Dixon argued for "people-oriented" training that emphasizes the patients who benefit from the "soup." All these problems have affected the quality of clean room workers. She noted that in the 1970s training material was written at the 10th grade level; today, it is at the 5th grade level.