059-17 Wyo. Code R. §§ 17-2 - Definitions
(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.
Notes
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No prior version found.