The space required to be maintained

The space required to be maintained at a Class 100 (Class A) level is significantly less than that for traditional aseptic rooms, and this can have important cost implications. The overall facility can be smaller, the Class 100 (Class A) space costs less than one-quarter the cost of clean space, and gowning areas can be eliminated. Additional benefits include more consistent assurance of sterility since the microbial and nonviable particulate content of the processing environment is constant—no operator involvement and more comfortable working conditions for employees. The actual level of sterility assurance should be greatly enhanced, possibly from 1 × 10 –3 to 10 –5 or 10 −6 .