USP 797 QUESTIONS WITH ANSWERS RATED A+
Ante-Area - An ISO Class 8 or better area where personnel hand hygiene and garbing
procedures, staging of
components, order entry, CSP labeling, and other high-particulate-generating activities are
performed.
Aseptic Processing - A mode of processing
pharmaceutical and medical products that involves the separate sterilization of the product and of
the package and the transfer of the product into the container and its closure
under at least ISO Class 5 conditions.
Beyond-Use Date (BUD) - the date or time after which a CSP shall not be stored or transported.
(BSC)Biological Safety Cabinet - A ventilated cabinet for CSPs, personnel, product, and
environmental protection having
an open front with inward airflow for personnel protection, downward high-efficiency particulate
air (HEPA)-filtered laminar
airflow for product protection, and HEPA-filtered exhausted air for environmental protection.
Buffer Area - An area where the primary engineering control (PEC) is physically located.
Activities that occur in this area
include the preparation and staging of components and supplies used when compounding CSPs.
</equal ISO 7
What is a PEC ? - Primary engineering control
Clean Room - A room in which the concentration of airborne particles is controlled to meet a
specified airborne particulate
cleanliness class.
(CACI)
Compounding Aseptic Containment Isolator - A compounding aseptic isolator (CAI) designed to
provide worker
protection from exposure to undesirable levels of airborne drug throughout the compounding and
material transfer processes
and to provide an aseptic environment for compounding sterile preparations.
(CAI) Compounding Aseptic Isolator - A form of isolator specifically designed for compounding
pharmaceutical ingredients
or preparations.
Critical Area - An ISO Class 5 environment.
ISO 5 >1 microbe contamination
, Critical Site - A location that includes any component or fluid pathway surfaces, or openings
exposed and at risk of direct contact with air, moisture, or touch contamination
(DCA)Direct Compounding Area - A critical area within the ISO Class 5 primary engineering
control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as
first air.
First AIR - Unidirectional HEPA-filtered air is also known as?
Hazardous Drugs - Drugs are classified as hazardous if studies in animals or humans indicate
that exposures to them have
a potential for causing cancer, development or reproductive toxicity, or harm to organs.
Media-Fill Test - A test used to qualify
aseptic technique of compounding personnel or processes and to ensure that the processes used
are able to produce sterile
product without microbial contamination.
Multiple-Dose Container - A multiple-unit container for articles or preparations
intended for parenteral administration only and usually containing antimicrobial preservatives.
Negative Pressure Room - A room that is at a lower pressure than the adjacent spaces and,
therefore, the net flow of air is
into the room
Pharmacy Bulk Package - A container of a sterile preparation for parenteral use that contains
many single doses
Primary Engineering Control (PEC) - A device or room that provides an ISO Class 5
environment for the
exposure of critical sites when compounding CSPs.
Positive Pressure Room - A room that is at a higher pressure than the adjacent spaces and,
therefore, the net airflow is out
of the room
Single-Dose Container - A single-dose container is a single-unit container
for articles or preparations intended for parenteral administration only.
Segregated Compounding Area - A designated space, either a demarcated area or room, that is
restricted to preparing low-risk level CSPs with 12-hour or less BUD.
Sterilizing Grade Membranes - Membranes that are documented to retain 100% of a culture of
107 microorganisms of a
Ante-Area - An ISO Class 8 or better area where personnel hand hygiene and garbing
procedures, staging of
components, order entry, CSP labeling, and other high-particulate-generating activities are
performed.
Aseptic Processing - A mode of processing
pharmaceutical and medical products that involves the separate sterilization of the product and of
the package and the transfer of the product into the container and its closure
under at least ISO Class 5 conditions.
Beyond-Use Date (BUD) - the date or time after which a CSP shall not be stored or transported.
(BSC)Biological Safety Cabinet - A ventilated cabinet for CSPs, personnel, product, and
environmental protection having
an open front with inward airflow for personnel protection, downward high-efficiency particulate
air (HEPA)-filtered laminar
airflow for product protection, and HEPA-filtered exhausted air for environmental protection.
Buffer Area - An area where the primary engineering control (PEC) is physically located.
Activities that occur in this area
include the preparation and staging of components and supplies used when compounding CSPs.
</equal ISO 7
What is a PEC ? - Primary engineering control
Clean Room - A room in which the concentration of airborne particles is controlled to meet a
specified airborne particulate
cleanliness class.
(CACI)
Compounding Aseptic Containment Isolator - A compounding aseptic isolator (CAI) designed to
provide worker
protection from exposure to undesirable levels of airborne drug throughout the compounding and
material transfer processes
and to provide an aseptic environment for compounding sterile preparations.
(CAI) Compounding Aseptic Isolator - A form of isolator specifically designed for compounding
pharmaceutical ingredients
or preparations.
Critical Area - An ISO Class 5 environment.
ISO 5 >1 microbe contamination
, Critical Site - A location that includes any component or fluid pathway surfaces, or openings
exposed and at risk of direct contact with air, moisture, or touch contamination
(DCA)Direct Compounding Area - A critical area within the ISO Class 5 primary engineering
control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as
first air.
First AIR - Unidirectional HEPA-filtered air is also known as?
Hazardous Drugs - Drugs are classified as hazardous if studies in animals or humans indicate
that exposures to them have
a potential for causing cancer, development or reproductive toxicity, or harm to organs.
Media-Fill Test - A test used to qualify
aseptic technique of compounding personnel or processes and to ensure that the processes used
are able to produce sterile
product without microbial contamination.
Multiple-Dose Container - A multiple-unit container for articles or preparations
intended for parenteral administration only and usually containing antimicrobial preservatives.
Negative Pressure Room - A room that is at a lower pressure than the adjacent spaces and,
therefore, the net flow of air is
into the room
Pharmacy Bulk Package - A container of a sterile preparation for parenteral use that contains
many single doses
Primary Engineering Control (PEC) - A device or room that provides an ISO Class 5
environment for the
exposure of critical sites when compounding CSPs.
Positive Pressure Room - A room that is at a higher pressure than the adjacent spaces and,
therefore, the net airflow is out
of the room
Single-Dose Container - A single-dose container is a single-unit container
for articles or preparations intended for parenteral administration only.
Segregated Compounding Area - A designated space, either a demarcated area or room, that is
restricted to preparing low-risk level CSPs with 12-hour or less BUD.
Sterilizing Grade Membranes - Membranes that are documented to retain 100% of a culture of
107 microorganisms of a
