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CETA CAG-003 EXAM WITH COMPLETE SOLUTIONS LATEST UPDATE
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CETA CAG-003 EXAM WITH COMPLETE SOLUTIONSLATEST UPDATE
ACPH
air changes per hour
- # of times air is replaced in room
Adverse Air Currents
Air currents that adversely affect the HEPA filtered unidirectional air flow of a buffer
room or primary engineering control.
Aerosol Diluter
A devise used for measuring total particle levels in a high concentration of aerosol
providing a representative sample that meets the input specifications of the discrete
particle counter.
Airlock
A room with interlocking doors designed to preserve air-pressure differentials when
materials transfer between two adjacent rooms (usually with varying air contamination
levels).
Allergenic Extracts Compounding Area
A specifically designated, unclassified space, room or area with a defined perimeter
having dimensions for which it is suitable to perform manipulations in preparation of
allergenic extract prescription sets.
ANSI
American National Standards Institute : A privately managed, nonprofit organization
that coordinates development and use of voluntary consensus standards within the
,United States.
Anteroom
ISO Calls 8 (or cleaner) room with fixed walls and doors where personnel hand hygiene,
garbing procedures, and other activities that generate high particulate levels may be
performed.
As-Built Conditions
Condition where the cleanroom or clean zone is complete with all services connected
and functioning but with no equipment, furniture, materials or personnel present.
Aseptic Processing
A method by which separate, sterile components are brought together under conditions
that maintain their sterility.
At-Rest Conditions
Condition where the cleanroom or clean zone is complete with all normal equipment and
supplies used for compounding installed and operating, but with no personnel present.
AVS
Airflow Visualization Study
AVS Output manifolds
Diffusers remote to the visible medium source intended to release the medium in a
method appropriate to the airflow visualization test being performed.
,Backstreaming
Airflow currents that move in a direction opposite to the HEPA filtered unidirectional
airflow because of turbulence created by an object in the airstream.
Beyond Use Date (BUD)
The date or time after which a CSP shall not be stored or transported.
Biosafety Cabinet (BSC), Class II
A cabinet that is ventilated with an open front and has unidirectional HEPA-filtered
airflow that moves inward and downward and is exhausted through a HEPA filter. A BSC
used to prepare a CSP must be able to provide an ISO Class 5 or better environment for
preparation of the CSPs.
Buffer Room
A room fixed with walls and doors that is ISO Class 7 or cleaner where the PECs that
generate and maintain and ISO Class 5 environment are physically located. May only be
entered through an Ante-room.
Category 1 CSP
A CSP that is assigned a BUD of 12 hours or less at controlled room temperature or 24
hours or less refrigerated that is compounded in accordance with all applicable
requirements for Cat 1 CSPs.
Category 2 CSP
A CSP that is assigned a BUD of greater than 12 hours at controlled room temperature
or greater than 24 hours refrigerated compounded in accordance with all applicable
requirements for Cat 2 CSPs.
Category 3 CSP
, A CSP that is sterility tested, supplemented by endotoxin testing when appropriate and
that has additional requirements than Cat 2 CSPs for personnel qualification, use of
sterile garb, use of sporicidal disinfectants frequency of environmental monitoring and
stability determination.
CFM
Cubic Feet per Minute (Air volume measurement)
Classified Area
An area that maintains an air quality classification based on the ISO standards.
Cleaning Agent
An agent for the removal of residues from surfaces.
Cleanroom Suite
A restricted area that consists of both an anteroom and a buffer room.
Compounded Sterile Preparation CSP
A sterile preparation that is compounded by mixing, combining, diluting, pooling,
reconstituting, repackaging, or otherwise manipulating a drug product or bulk drug
substance.
Compounding
The preparation, mixing, assembly, alteration, packaging, and labeling of a drug or bulk
drug substance in order to prepare a sterile medication.
Compounding Area
The area where compounding is occurring.
Compounding Aseptic Containment Isolator (CACI)
A form of RABS that utilizes HEPA filtration in providing an ISO Class 5 unidirectional air
environment designed for the compounding of sterile HDs.
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