Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-2 - Definitions

Current through July 13, 2024
(a) "Ante-room" means an ISO Class 8 or
				cleaner room with fixed walls and doors where activities that generate high
				particulate levels are performed. It is the transition room between the
				unclassified area of the facility and the buffer room, in which pressure
				relationships are constantly maintained and large disturbances requiring
				response from the heating, ventilating, and air-conditioning control system are
				reduced.
(b) "Aseptic Technique"
				means processing of pharmaceutical products that involves the separate
				sterilization of the product and of the package, if not already sterilized, and
				the transfer of the product into the container and its closure under at least
				ISO Class 5 conditions.
(c)
				"Beyond-Use Date" (BUD) means the date, or the time and date, beyond which a
				preparation shall not be used and shall be discarded. It is determined from the
				date or time that preparation of the CSP is initiated and is dependent on
				individual compounding factors.
(d)
				"Buffer Room" means an ISO Class 7 or cleaner room with fixed walls and doors
				where the Primary Engineering Control is physically located. The buffer room
				may only be accessed through the ante-room.
(e) "Cleaning agent" means an agent for the
				removal of residues from surfaces.
(f) "Cleanroom Suite" means the classified
				area consisting of both the ante-room and buffer room.
(g) "Closed System Transfer Device" (CSTD)
				means a drug transfer device that mechanically prohibits entrance of
				contaminants into the system and escape of hazardous drug or vapor from the
				system.
(h) "Compounded Sterile
				Preparation" (CSP) means a preparation intended to be sterile that is created
				by combining, admixing, diluting, pooling, reconstituting, repackaging, or
				otherwise altering a drug product or bulk drug substance.
(i) "Disinfectant" means a chemical or
				physical agent used on an inanimate surface and objects to destroy fungi,
				viruses, and bacteria. Sporicidal disinfectant agents are considered a special
				class of disinfectants that also are effective against bacterial and fungal
				spores.
(j) "Dynamic operating
				conditions" means conditions in which operating pharmacy staff are present and
				simulating or performing compounding. The conditions shall reflect the largest
				number of pharmacy staff and highest complexity of compounding expected during
				routine operations as determined by the designated person(s).
(k) "Hazardous Drugs" (HDs) means drugs in
				which studies in animals or humans indicate that exposures to them have a
				potential for causing cancer, development or reproductive toxicity, or harm to
				organs.
(l) "ISO Class" means an
				air-quality classification from the International Organization for
				Standardization that limits the number of particles of 0.5 micrometers and
				larger per cubic meter.
Class Name
Particle Count:
ISO Class 3
35.2/m3
ISO Class 4
352/m3
ISO Class 5
3,520/m3
ISO Class 6
35,200/m3
ISO Class 7
352,000/m3
ISO Class 8
3,520,000/m3
(m)
				"Media-Fill Test" means a simulation used to qualify processes and pharmacy
				staff engaged in sterile compounding to ensure that the processes and personnel
				are able to prepare CSPs without contamination.
(n) "One-step disinfectant cleaner" means a
				product with an EPA-registered or equivalent claim that it can clean and
				disinfect a non-porous surface in the presence of light to moderate organic
				soiling without a separate cleaning step.
(o) "Primary Engineering Control" (PEC) means
				a device that provides an ISO Class 5 or better air quality environment and
				utilizes unidirectional HEPA filtration for sterile compounding.
(p) "Quality Assurance" (QA) means the system
				of procedures, activities, and oversight that ensures that the compounding
				process consistently meets quality standards.
(q) "Quality Control" (QC) means the
				sampling, testing, and documentation of results that, taken together, ensure
				that specifications have been met before release of the CSP.
(r) "Secondary Engineering Control" (SEC)
				means the area where the PEC is placed.
(s) "Segregated Compounding Area" (SCA) means
				a designated, unclassified space, area, or room with a defined perimeter that
				contains a PEC and is suitable for preparation of Low-Risk CSPs only.
(t) "Sporicidal agent" means a
				chemical or physical agent that destroys bacterial and fungal spores when used
				in sufficient concentration for a specified contact time. It is expected to
				kill all vegetative microorganisms.