Section Phar 15.30 - Definitions In this subchapter:
(1) "Ante area" means an ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, labeling and other high particulate generating activities are performed. The ante-area is the transition area between the unclassified area of the facility and the buffer area.(2) "Buffer area" means an ISO Class 7 or ISO Class 8 if using an isolator or cleaner area where the primary engineering control that generates and maintains an ISO Class 5 environment is physically located.(3) "Category 1" means a compounded sterile preparation compounded with a primary engineering control in a segregated compounding area.(4) "Category 2" means a compounded sterile preparation compounded with a primary engineering control in a classified area.(5) "Clean" means to physically remove debris, dirt, dust, and other impurities from surfaces or objects using a cleaning agent with a detergent.(6) "Compounded sterile preparation" means a compounded final preparation intended to be sterile through the BUD.(7) "Compounded stock solution" means a compounded solution to be used in the preparation of multiple units of a finished compounded sterile preparation.(8) "Critical site" means a location that includes any component or fluid pathway surfaces or openings that are exposed and at risk of direct contact with air, moisture, or touch contamination.(9) "Disinfect" means the killing of microorganisms when used according to the disinfectant's label.(10) "HEPA" means high-efficiency particulate air.(10m) "High-risk level compounded sterile preparations" means preparations compounded from non-sterile ingredients or from ingredients that are incorporated using non-sterile equipment before terminal sterilization, or from commercially manufactured sterile products that lack effective antimicrobial preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality worse than ISO class 5 for more than one hour. High-risk level compounded sterile preparations include water containing preparations that are stored for more than six hours before terminal sterilization.(11) "ISO Class 5" means conditions in which the air particle count is no greater than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air.(12) "ISO Class 7" means conditions in which the air particle count is no greater than a total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air.(13) "ISO Class 8" means conditions in which the air particle count is no greater than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air.(14) "Isolator" means an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air operated at a continuously higher pressure than its surrounding environment and is decontaminated using an automated system. An isolator uses only decontaminated interfaces or rapid transfer ports for materials transfer.(14g) "Low-risk level compounded sterile preparations" means preparations compounded with aseptic manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products, components, and devices. The low-risk level sterile compounding process involves only transfer, measuring, and mixing, using no more than three commercially manufactured sterile products, and not more than two entries into one sterile container or package to make the compounded sterile preparations.(14r) "Medium-risk level compounded sterile preparations" means preparations compounded under low-risk level conditions but which require multiple individual or small doses of sterile products to be combined or pooled to prepare compounded sterile preparations that will be administered either to multiple patients or to one patient on multiple occasions. The medium-risk level sterile compounding process includes complex aseptic manipulations other than single volume transfer, and requires an unusually long duration, such as that required to complete dissolution or homogeneous mixing.(15) "Primary engineering control" means a device or zone that provides an ISO Class 5 environment for sterile compounding.(16) "Restricted access barrier system (RABS)" means an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air that allows for the ingress or egress of materials through defined openings that have been designed and validated to preclude the transfer of contamination, and that generally are not to be opened during operations. RABS include compounding aseptic isolators and compounding aseptic containment isolators.(17) "Sterility assurance level of 10 -6" means an equivalent to a probability that one unit in a million is nonsterile.(18) "Segregated compounding area" means a designated, unclassified space, area, or room that contains a primary engineering control.(19) "Urgent use compounded sterile preparation" means a preparation needed urgently for a single patient and preparation of the compounded sterile preparation under Category 1 or Category 2 requirements would subject the patient to additional risk due to delays.Wis. Admin. Code Pharmacy Examining Board Phar 15.30
Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018Amended by, CR 22-007: cr. (10m), (14g), (14r) Register July 2022 No. 799, eff. 8/1/2022.