CETa UPDATED QUESTIONS AND ANSWERS GRADED A+
✔✔How do you calculate CFU on media fill and gft testing? - ✔✔the total count of CFU
from both hands.
if no colonies are recovered the results are listed as less than detection level.
<1CFU/both hands
✔✔CSTD - ✔✔closed-system transfer device
✔✔TSB - ✔✔tryptic soy broth
✔✔MFU - ✔✔Media Fill Units
✔✔What is the purpose of a media fill test? - ✔✔Media Fill testing is used to measure
the aseptic skill of compounding personnel.
✔✔What type of media should be used if the organization performs non-sterile to sterile
compounding? - ✔✔dehydrated media must be used as part of he media fill
✔✔How long does a MFU need to be incubated? - ✔✔20-25 degrees for 7 days, then
gently swirl i 30-35 for an additional 7 days. The order of temperature must be
described by the facility SOP.
✔✔Does do you express results of a MFU? - ✔✔either clear or turbid
✔✔Activity Level - ✔✔The current operational condition in the area where the viable
environmental monitoring is being performed
✔✔Dual Plate Method - ✔✔Two devices, at least one is TSA collected at the same
sample location. Each device is incubated at different time and temp conditions
✔✔Growth Promotion - ✔✔A study where an unexposed sampling device is inoculated
with specific microoganisms in specific quantities and compared to an expected number
of CFU after incubation, normally performed by the mfg for the certificate of analysis
✔✔IVLFZ - ✔✔integrated vertical laminar flow zone
✔✔What are the 3 different type of operating conditions - ✔✔As Built, At Rest,
Operational/dynamic
✔✔SDA - ✔✔Sabouraud dextrose agar
,✔✔What are two examples of fungal media? - ✔✔MEA (Malt Extract Agar) and SDA
Sabouraud Dextrose Agar
✔✔Why does media used for sampling need to incorporate neutralizers? - ✔✔Lecithin
and polysorbate 80 can neutralize a wide range of chemicals used to cleaning
controlled areas.
✔✔What tests are performed on the media for quality control? - ✔✔growth promotion,
pH, and sterlization, and is done by the mfg.
✔✔How many liters of air should you collect for viable air samples? - ✔✔1000 L
✔✔What is the probe size for aerosol photometer? - ✔✔Probe area shall have a
maximum opening of 1.7 in2 and a minimum dimension of .50 inches.
✔✔What is the FDA guidance range for LAFW air velocity? - ✔✔72-108 FPM
✔✔What is the rate of speed to perform the HEPA leak test with the photometer probe?
- ✔✔2inches per second with overlapping strokes. The probe should be no more than in
inch from the area being tested.
✔✔Environmental Monitoring - ✔✔Semi-quantitative evaluation to assess the continued
control of contamination
✔✔NIOSH - ✔✔National Institute for Occupational Safety and Health
✔✔refrigerators used for HD storage - ✔✔exhaust located adjacent to the refrigerator's
compressor and behind the refrigerator should be considered.
✔✔API - ✔✔Active Pharmaceutical Ingredient
✔✔What are requirements of a C-SEC - ✔✔externally vented, be physically separated,
have appropriate acph, must have a negative pressure between negative 0.01 and 0.03
inches of water column relative to adjacent areas
✔✔Describe an HD sterile compounding setup - ✔✔Iso Class 7 buffer room with an iso
class 7 ante room, C-PEC (externally vented) BSC Class II OR A CACI, C-SEC is
externally vented, 30 ACPH, negative pressure 0.01 to 0.03.
✔✔Describe a C-SCA - ✔✔Containment-Segregated Compounding Area - This is an
unclassified space, with an externally vented BSC Class II or a CACI, negative pressure
room 0.01-0.030, 12 ACPH externally vented. BUD is for category 1 drugs
, ✔✔How far does the sink in an HD ante room need to be away from the entrance to the
HD buffer room? - ✔✔1 meter
✔✔What are the requirements if an HD buffer room is entered through a Non-HD buffer
room? - ✔✔Line of Demarcation in the negative room for donning/doffing garb, there
must be a method of transporting HD drugs out of the HD buffer room, i.e. pass thrus.
✔✔CSTD - ✔✔closed system drug transfer device
✔✔CSTD definition - ✔✔A drug-transfer device that mechanically prohibits the transfer
of environmental contaminants into the system and the escape of HD or vapor
concentrations outside the system.
✔✔What are the 3 engineering controls for HD CSP - ✔✔Primary, Secondary,
Supplemental
✔✔Unidirectional Airflow - ✔✔An airflow moving in a single direction, in a robust and
uniform manner, and at sufficient speed to reproducibly sweep particles away from the
critical processing or testing area
✔✔ISO - ✔✔International Organization for Standardization
✔✔As Built - ✔✔condition where the cleanroom is complete with all services connected
and functioning but with no equipment, furniture, materials or personnel present
✔✔at-rest - ✔✔condition of the cleanroom is complete with equipment installed and
operating in a manner agreed upon, but with no personnel present.
✔✔operational condition - ✔✔agreed condition where the cleanroom is functioning with
equipment operating and with specified number of personnel present
✔✔How is particle size measured? - ✔✔numbers of particles per cubic meter
✔✔LSAPC - ✔✔Light Scattering Airborne Particle Counter
✔✔PAO - ✔✔Polyalphaolefin
✔✔Visual Smoke Study - ✔✔A test, used in ISO Class 7 and ISO Class 8 rooms that do
not haveunidirectional airflow, in which a visible source of smoke, which is close to
neutrally buoyant, isused to verify an absence of stagnant airflow where particulates can
accumulate. This test doesnot need to be performed under dynamic operating
conditions and is not appropriate for PECs(see Dynamic airflow smoke pattern test).
This test is done when an ISO Classified room hasceiling mounted air returns. It only
✔✔How do you calculate CFU on media fill and gft testing? - ✔✔the total count of CFU
from both hands.
if no colonies are recovered the results are listed as less than detection level.
<1CFU/both hands
✔✔CSTD - ✔✔closed-system transfer device
✔✔TSB - ✔✔tryptic soy broth
✔✔MFU - ✔✔Media Fill Units
✔✔What is the purpose of a media fill test? - ✔✔Media Fill testing is used to measure
the aseptic skill of compounding personnel.
✔✔What type of media should be used if the organization performs non-sterile to sterile
compounding? - ✔✔dehydrated media must be used as part of he media fill
✔✔How long does a MFU need to be incubated? - ✔✔20-25 degrees for 7 days, then
gently swirl i 30-35 for an additional 7 days. The order of temperature must be
described by the facility SOP.
✔✔Does do you express results of a MFU? - ✔✔either clear or turbid
✔✔Activity Level - ✔✔The current operational condition in the area where the viable
environmental monitoring is being performed
✔✔Dual Plate Method - ✔✔Two devices, at least one is TSA collected at the same
sample location. Each device is incubated at different time and temp conditions
✔✔Growth Promotion - ✔✔A study where an unexposed sampling device is inoculated
with specific microoganisms in specific quantities and compared to an expected number
of CFU after incubation, normally performed by the mfg for the certificate of analysis
✔✔IVLFZ - ✔✔integrated vertical laminar flow zone
✔✔What are the 3 different type of operating conditions - ✔✔As Built, At Rest,
Operational/dynamic
✔✔SDA - ✔✔Sabouraud dextrose agar
,✔✔What are two examples of fungal media? - ✔✔MEA (Malt Extract Agar) and SDA
Sabouraud Dextrose Agar
✔✔Why does media used for sampling need to incorporate neutralizers? - ✔✔Lecithin
and polysorbate 80 can neutralize a wide range of chemicals used to cleaning
controlled areas.
✔✔What tests are performed on the media for quality control? - ✔✔growth promotion,
pH, and sterlization, and is done by the mfg.
✔✔How many liters of air should you collect for viable air samples? - ✔✔1000 L
✔✔What is the probe size for aerosol photometer? - ✔✔Probe area shall have a
maximum opening of 1.7 in2 and a minimum dimension of .50 inches.
✔✔What is the FDA guidance range for LAFW air velocity? - ✔✔72-108 FPM
✔✔What is the rate of speed to perform the HEPA leak test with the photometer probe?
- ✔✔2inches per second with overlapping strokes. The probe should be no more than in
inch from the area being tested.
✔✔Environmental Monitoring - ✔✔Semi-quantitative evaluation to assess the continued
control of contamination
✔✔NIOSH - ✔✔National Institute for Occupational Safety and Health
✔✔refrigerators used for HD storage - ✔✔exhaust located adjacent to the refrigerator's
compressor and behind the refrigerator should be considered.
✔✔API - ✔✔Active Pharmaceutical Ingredient
✔✔What are requirements of a C-SEC - ✔✔externally vented, be physically separated,
have appropriate acph, must have a negative pressure between negative 0.01 and 0.03
inches of water column relative to adjacent areas
✔✔Describe an HD sterile compounding setup - ✔✔Iso Class 7 buffer room with an iso
class 7 ante room, C-PEC (externally vented) BSC Class II OR A CACI, C-SEC is
externally vented, 30 ACPH, negative pressure 0.01 to 0.03.
✔✔Describe a C-SCA - ✔✔Containment-Segregated Compounding Area - This is an
unclassified space, with an externally vented BSC Class II or a CACI, negative pressure
room 0.01-0.030, 12 ACPH externally vented. BUD is for category 1 drugs
, ✔✔How far does the sink in an HD ante room need to be away from the entrance to the
HD buffer room? - ✔✔1 meter
✔✔What are the requirements if an HD buffer room is entered through a Non-HD buffer
room? - ✔✔Line of Demarcation in the negative room for donning/doffing garb, there
must be a method of transporting HD drugs out of the HD buffer room, i.e. pass thrus.
✔✔CSTD - ✔✔closed system drug transfer device
✔✔CSTD definition - ✔✔A drug-transfer device that mechanically prohibits the transfer
of environmental contaminants into the system and the escape of HD or vapor
concentrations outside the system.
✔✔What are the 3 engineering controls for HD CSP - ✔✔Primary, Secondary,
Supplemental
✔✔Unidirectional Airflow - ✔✔An airflow moving in a single direction, in a robust and
uniform manner, and at sufficient speed to reproducibly sweep particles away from the
critical processing or testing area
✔✔ISO - ✔✔International Organization for Standardization
✔✔As Built - ✔✔condition where the cleanroom is complete with all services connected
and functioning but with no equipment, furniture, materials or personnel present
✔✔at-rest - ✔✔condition of the cleanroom is complete with equipment installed and
operating in a manner agreed upon, but with no personnel present.
✔✔operational condition - ✔✔agreed condition where the cleanroom is functioning with
equipment operating and with specified number of personnel present
✔✔How is particle size measured? - ✔✔numbers of particles per cubic meter
✔✔LSAPC - ✔✔Light Scattering Airborne Particle Counter
✔✔PAO - ✔✔Polyalphaolefin
✔✔Visual Smoke Study - ✔✔A test, used in ISO Class 7 and ISO Class 8 rooms that do
not haveunidirectional airflow, in which a visible source of smoke, which is close to
neutrally buoyant, isused to verify an absence of stagnant airflow where particulates can
accumulate. This test doesnot need to be performed under dynamic operating
conditions and is not appropriate for PECs(see Dynamic airflow smoke pattern test).
This test is done when an ISO Classified room hasceiling mounted air returns. It only
