Section 15.02. Definitions.

  In this chapter:

(1)  "Aseptic preparation" means preparation using procedures designed to preclude contamination of drugs, packaging equipment or supplies by microorganisms during processing.

(2)  "Biological safety cabinet" means a containment unit suitable for preparation of low- to moderate- risk agents where there is a need for protection of the product, personnel and environment, according to national sanitation foundations standard 49.

(3)  "Class 100 environment" means an atmospheric environment that contains less than 100 particles 0.5 microns in diameter per cubic foot of air, as described in federal standard 209.

(4)  "Critical activities" means activities that are different from other activities due to the increased potential opportunity for contamination to occur.

(5)  "Critical objects" means objects that are different from other objects due to the increased potential opportunity for contamination to occur.

(6)  "Cytotoxic drug" means a pharmaceutical used therapeutically as a toxin to alter biochemical activities of phases of cellular division which uniquely contribute to normal cell growth.

(7)  "OSHA" means the federal occupational safety and health administration.

(8)  "Parenteral" means a preparation of drugs for injection through one or more layers of skin.

(9)  "Practice of pharmacy" has the meaning given in s. 450.01 (16) , Stats.

(10)  "Sterile pharmaceutical" means any dosage form devoid of viable microorganisms, including but not limited to parenterals, injectables and ophthalmics.

History: Cr. Register, March, 2000, No. 531 , eff. 4-1-00.

Note

"Federal Standard 209" refers to Federal standard 209E: airborne particulate cleanliness classes in cleanrooms and clean zones by the Institute of Environmental Sciences published by the Institute of Environmental Sciences in 1992 and used by the United States General Services Administration as the standard required for use by federal agencies utilizing clean room controlled environments. Microsoft Windows NT 6.1.7601 Service Pack 1