Effect of Personal Protection Equipment Utilizing Compounding Aseptic Isolators
February 27, 2007
This study was done in 2006 by D. Brown, A. Nace and R. Bercume from the department of Pharmacy Services at the UMass Memorial Medical Center, in Worcester, Massachusetts to demonstrate the effect of personnel cleansing and PPE while compounding sterile products using CAIs, to provide written documentation of environmental testing to isolator manufacturer, to comply with the USP 797 standards and to perform testing under normal working conditions.. The CAIs used are The MicroSphereTM manufactured by Isotech Design. The sterile environment of four different models of the MicroSphereTM CAIs in three separate locations were unaffected by whether or not the operators were wearing PPE. The effect of personnel cleansing and the presence of makeup, jewelry, and ear percing had no effect on the air sampling results in the four CAIs tested.