EVALUATION OF AIR-QUALITY IN A STERILE-DRUG PREPARATION AREA WITH AN ELECTRONIC PARTICLE COUNTER

The air quality in a sterile-drug preparation area was assessed with an electronic particle counter. The numbers of airborne particles of greater-than-or-equal-to 0.5 and >5 mum in a hospital i.v. room were determined. Initially, a total of seven sampling sites were designated; the four locations and four times with the highest concentrations of particles were analyzed. To determine the classification of the clean-room, as described in Federal Standard 209E (FS209E), four equally spaced locations in the room were examined on one day. According to FS209E, the average concentration of particles in samples obtained at each of four locations uniformly spaced in a room must be less-than-or-equal-to 100,000 per cubic foot of sampled air for particles of greater-than-or-equal-to 0.5 mum in order for a room to qualify as a Class 100,000 cleanroom. Throughout the seven-day initial study, all measurements of particles of greater-than-or-equal-to 0.5 mum except one yielded counts of <100,000/cu ft. The four highest average particle concentrations were recorded at 1000, 1100, 1400, and 1500. Although measurement of particles of >5 mum was not necessary, the measurements of these particles showed that their concentrations were highly dependent on staff activity. The average particle concentration at the four equally spaced locations was <36,000/cu ft. At the four locations, the mean of the average concentrations was 29,664 particles per cubic foot. The upper limit of the 95% confidence interval for particle concentration at the four locations was 35,896/cu ft. A follow-up monitoring plan was developed, and steps to improve i.v. room air quality were outlined. A particle counter successfully evaluated the air quality in a sterile-drug preparation area over a range of times and locations.