Mark A. DeSorbo
WASHINGTON, D.C. DR. Robert J. Mello will not stand for such horrific sounding microorganisms as anthrobacter globuformis and staphylococcus aureus in cleanrooms or non-classed areas.
He developed an even deeper aversion to these types of process-hindering bacteria when Chesapeake Biological Laboratories Inc. (Baltimore) initiated the laborious task of disinfecting its northwest Baltimore facility.
“We learned a lot from that,” says Mello, vice president for quality and regulatory affairs. “You learn what you can and cannot clean.”
So when it came time to disinfect the new facility near Camden Yards, completed in December 1997, Mello and Dr. Barry Friedman, Chesapeake's laboratory services director, were ready.
The trials, tribulations and success of this effort were the heart of “Environmental Monitoring in an Aseptic Processing Facility,” a presentation at the 1999 PDA annual meeting, held here in late November.
A cleaning protocol, he says, called for broom and vacuum cleaning of all rooms, followed by rinsing ceiling, walls and floors with water. Class 100 and 1,000 cleanrooms were treated with all cleaning and spore-killing agents, while antibacterial solutions alone were applied to Class 10,000 and 100,000 cleanrooms.
“We came up with a protocol after reviewing a number of proposals, we decided to use agents that contained phenol, paracetic acid, hydrogen peroxide and isopropyl alcohol,” Friedman says, adding that disinfecting the facility occurred from April through June 1998.
A detection protocol employed air-sampling monitors, microorganism collection plates, swab samples and the climate was also evaluated, he explains. The Class 100 and 1,000 cleanrooms were tested daily after being sanitized, and the Class 10,000 and 100,000 cleanrooms were evaluated over three, non-consecutive days. Subsequent tests for three weeks at a minimum of two to three times per week were conducted when personnel were in the cleanrooms. The detection protocol also mandated that all area and sampling locations were mapped, while a key of critical sampling sites was drafted and data summary sheets were kept.
Friedman says the results did not yield what they expected. Microorganisms, like mold spores, were still found throughout classed areas. “Although we had killed most of the organisms, we had to disinfect the facility again to meet [cleanroom] class compliance,” he says. “What really helped was the mammoth quantity of plates we collected. They were a great database for us to fall back on.”
That saved Chesapeake from having to go back to the drawing board. Once the facility was disinfected, a rigid and regular cleaning protocol was put into action. “Floors are washed daily. Walls are washed once a week and ceilings are washed once a month,” Friedman says.