SC, exam 1: clean room
The ability to consistently produce sterile preparations is directly related to _____ -
ANS-design and maintenance of the sterile compounding facility
traffic in clean room - ANS-minimized, only go in if you have a reason to
what can be brought in? - ANS-Only the furniture, equipment, supplies and other
material required for the compounding activities to be performed
surfaces and furniture need to be ___ - ANS-non-porous, smooth, non-shedding,
impermeable, cleanable and resistant to disinfectants
carts should be ___ - ANS-stainless steel wire, non-porous plastic, or sheet metal
construction with good quality cleanable casters to promote mobility
types of carts - ANS-work, supply, delivery, transport
primary engineering control - ANS-device or room that provides an environment for
compounding CSPs
Laminar Airflow Workbenches (LAFW) - ANS-A controlled environment created by a
high efficiency particulate air (HEPA) filter to retain airborne particles and
microorganisms, and its use decreases the chance of contamination of compounded
preparations. Air is drawn through a pre-filter into a blower then blown into a plenum
where the air finally passes through a HEPA filter across a partially enclosed work
surface (back to front in a horizontal hood). Provides product protection from particles
LAFW has what type of airflow? - ANS-unidirectional
LAFW is used for ___ drugs - ANS-non-hazardous
biological safety cabinets has three types, all are ___ pressure - ANS-negative
BSC class 1 - ANS-fume hood; used in labs. personnel and environmental protection,
no product protection. excellent for non-sterile hazardous drugs
, BSC class 2 - ANS-Sterile Hazardous Compounding; the most common. Personnel,
environmental and product protections. Downward HEPA filtered air for product
protection. HEPA filtered exhausted air for environmental protection
BSC class 3 - ANS-Maximum containment. Gas-Tight
CAI - ANS-USP <797> references the Controlled Environment Testing Association
(CETA) applications guide for issues relating to isolators
CETA provides certification guidance for the manufacturer and the certifier
A form of isolator specifically designed for compounding pharmaceutical ingredients or
preparations - Positive Pressure. Designed to maintain an aseptic compounding
environment within the isolator throughout the compounding and material transfer
processes. Air exchange into the isolator from the surrounding environment should not
occur unless the air has first passed through a microbially retentive HEPA filter
CACI - ANS-A compounding aseptic isolator 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 - Negative Pressure.
Air exchange with the surrounding environment should not occur unless the air is first
passed through a microbial retentive HEPA filter capable of containing airborne
concentrations of the physical size and state of the drug being compounded
iii. Where volatile hazardous drugs are prepared, the exhaust air from the isolator
should be appropriately removed by properly designed building ventilation
unidirectional/laminar flow - ANS-This prevents cross contamination from adjacent
areas. An airflow moving in a single direction in a robust and uniform manner and at a
sufficient speed to reproducibly sweep particles away from critical processing area. In
situ air pattern analysis via smoke studies shall be conducted at the critical area to
demonstrate unidirectional airflow and sweeping action over and away from the product
under dynamic conditions
HEPA filter removes ___ of particles that are ___ micrometers in size or larger -
ANS-99.97%; 0.3
where are PECs? - ANS-buffer room, a restricted access area
PEC should be left on at all times. if it's turned off, it should be ___ - ANS-allowed to run
for 15-30 minutes before using for compounding
The ability to consistently produce sterile preparations is directly related to _____ -
ANS-design and maintenance of the sterile compounding facility
traffic in clean room - ANS-minimized, only go in if you have a reason to
what can be brought in? - ANS-Only the furniture, equipment, supplies and other
material required for the compounding activities to be performed
surfaces and furniture need to be ___ - ANS-non-porous, smooth, non-shedding,
impermeable, cleanable and resistant to disinfectants
carts should be ___ - ANS-stainless steel wire, non-porous plastic, or sheet metal
construction with good quality cleanable casters to promote mobility
types of carts - ANS-work, supply, delivery, transport
primary engineering control - ANS-device or room that provides an environment for
compounding CSPs
Laminar Airflow Workbenches (LAFW) - ANS-A controlled environment created by a
high efficiency particulate air (HEPA) filter to retain airborne particles and
microorganisms, and its use decreases the chance of contamination of compounded
preparations. Air is drawn through a pre-filter into a blower then blown into a plenum
where the air finally passes through a HEPA filter across a partially enclosed work
surface (back to front in a horizontal hood). Provides product protection from particles
LAFW has what type of airflow? - ANS-unidirectional
LAFW is used for ___ drugs - ANS-non-hazardous
biological safety cabinets has three types, all are ___ pressure - ANS-negative
BSC class 1 - ANS-fume hood; used in labs. personnel and environmental protection,
no product protection. excellent for non-sterile hazardous drugs
, BSC class 2 - ANS-Sterile Hazardous Compounding; the most common. Personnel,
environmental and product protections. Downward HEPA filtered air for product
protection. HEPA filtered exhausted air for environmental protection
BSC class 3 - ANS-Maximum containment. Gas-Tight
CAI - ANS-USP <797> references the Controlled Environment Testing Association
(CETA) applications guide for issues relating to isolators
CETA provides certification guidance for the manufacturer and the certifier
A form of isolator specifically designed for compounding pharmaceutical ingredients or
preparations - Positive Pressure. Designed to maintain an aseptic compounding
environment within the isolator throughout the compounding and material transfer
processes. Air exchange into the isolator from the surrounding environment should not
occur unless the air has first passed through a microbially retentive HEPA filter
CACI - ANS-A compounding aseptic isolator 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 - Negative Pressure.
Air exchange with the surrounding environment should not occur unless the air is first
passed through a microbial retentive HEPA filter capable of containing airborne
concentrations of the physical size and state of the drug being compounded
iii. Where volatile hazardous drugs are prepared, the exhaust air from the isolator
should be appropriately removed by properly designed building ventilation
unidirectional/laminar flow - ANS-This prevents cross contamination from adjacent
areas. An airflow moving in a single direction in a robust and uniform manner and at a
sufficient speed to reproducibly sweep particles away from critical processing area. In
situ air pattern analysis via smoke studies shall be conducted at the critical area to
demonstrate unidirectional airflow and sweeping action over and away from the product
under dynamic conditions
HEPA filter removes ___ of particles that are ___ micrometers in size or larger -
ANS-99.97%; 0.3
where are PECs? - ANS-buffer room, a restricted access area
PEC should be left on at all times. if it's turned off, it should be ___ - ANS-allowed to run
for 15-30 minutes before using for compounding
