Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.30 - Definitions

Current through June 24, 2024
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.