CETa UPDATED EXAMS SET QUESTIONS AND ANSWERS
GRADED A+
✔✔How many air changes per hour for ISO 8 Class Rooms? - ✔✔The total HEPA-
filtered air change rate must be adequate to maintain ISO Class 8 under dynamic
operating conditions considering the factors listed above
At least 15 ACPH of the total air change rate in a room must come from the HVAC
through HEPA filters located in the ceiling
Rooms where activity levels are high may require more HEPA-filtered ACPH to maintain
ISO Class 8 air quality under dynamic operating conditions
The total ACPH must be documented on the certification report
✔✔How many air changes per hour in an Unclassified SCA? - ✔✔No requirement
✔✔What is the pressure differential requirement for a SCA for non-hazardous drug
compounding? - ✔✔No requirement
✔✔Certification of the classified areas including the PEC must be performed initially,
and recertification must be performed at least every 6 months and must include <USP
797> - ✔✔Airflow testing: Airflow testing is performed to determine acceptability of the
air velocity, the room air exchange rate, and the room pressure differential in doorways
between adjacent rooms to ensure consistent airflow and that the appropriate quality of
air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH
contributed from the PEC, and the total ACPH must be documented on the certification
report.
HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then
leak tested again after installation and as part of recertification.
Total particle count testing: (See 5.1 Total Airborne Particle Sampling.) Total particle
count testing must be performed under dynamic operating conditions using calibrated
electronic equipment.
Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each
PEC during dynamic operating conditions to demonstrate unidirectional airflow and
sweeping action over and away from the preparation(s).
✔✔Does the number of personnel present in each PEC and SEC during total particle-
count tests and dynamic airflow smoke-pattern test need to be documented? - ✔✔Yes
✔✔The microbiological air and surface monitoring program must include - ✔✔1 - viable
impact volumetric airborne particulate sampling
,2- surface sampling
✔✔What are the goals of microbiological air and surface morning program? - ✔✔To
determine whether contamination is present at unacceptable levels and to assess
whether proper personnel practices are being followed, cleaning and disinfecting agents
are effective, and environmental quality is maintained.
✔✔How often does viable air sampling need to be done for entities compounding
category 1 or 2 CSP? - ✔✔At least every 6 months
✔✔How often does viable air sampling need to be done for entities compounding
category 3 CSP? - ✔✔This must be done within 30 days prior to commencement of any
category 3 compounding and at least monthly thereafter
✔✔Active Air Sampling Procedures for Viable Airborne Monitoring - ✔✔1. Follow the
manufacturer's instructions for operation of the impaction air sampler, including
placement of media device(s).
2. Using the impaction air sampler, test at least 1 cubic meter or 1000 L of air from each
location sampled.
3. At the end of each sampling period, retrieve the media device and cover it. Handle
and store media devices to avoid contamination and prevent condensate from dropping
onto the agar during incubation and affecting the accuracy of the cfu reading (e.g.,
invert plates).
4. Incubate the media device at 30°-35° for no less than 48 h. Examine for growth.
Record the total number of discrete colonies of microorganisms on each media device
as cfu per cubic meter of air on an environmental sampling form based on sample type
(i.e., viable air), sample location, and sample date.
5. Then incubate the media device at 20°-25° for no less than 5 additional days.
Examine for growth. Record the total number of discrete colonies of microorganisms on
each media device as cfu per cubic meter of air on an environmental sampling form
based on sample type (i.e., viable air), sample location, and sample date.
6. Alternatively, to shorten the overall incubation period, two sampling media devices
may be collected for each sample location and incubated concurrently.
A. Both media devices could be TSA or one media device could be TSA and the other
fungal media (e.g., malt extract agar [MEA] or Sabouraud dextrose agar [SDA]).
B. Incubate each media device in a separate incubator. Incubate one media device at
30°-35° for no less than 48 h, and incubate the other media device at 20°-25° for no
less than 5 days. If fungal media are used as one of the samples, incubate the fungal
media sample at 20°-25° for no less than 5 days.
C. Count the total number of discrete colonies of microorganisms on each media
,✔✔What are the action levels for Viable Airborne Particle Air Sampling? - ✔✔Iso Class
5 - Greater than 1
Iso Class 7 - Greater than 10
Iso Class 8 - Greater than 100
✔✔Action Levels - ✔✔The quantity of colony forming units (CFU) at which the state of
contamination control is lost, warranting investigation and mitigation of cause.
✔✔Aseptic - ✔✔A state of control, void of unwanted microbial contamination
✔✔CFU - ✔✔A measure of the total number of microorganisms present on a sampling
device after incubation to estimate the total viable microbial inhabitance of an area
sample
✔✔Don - ✔✔to put on garbing materials
✔✔Detection Level - ✔✔The lowest qty or concentration that can be reliably recovered
with a given analytical method
✔✔Growth Promotion - ✔✔A study where an unexposed sampling device is inoculated
with specific microorganisms in specific qty and compared to the expected number of
colony forming units after incubation.
✔✔Irradiated - ✔✔A method of sterilization through controlled exposure to gamma wave
radiation. This is commonly used for sterilizing microbial growth media.
✔✔TSA - ✔✔Tryptic Soy Agar
This is suitable for recovery of both bacterial and fungal organisms
✔✔What neutralizers are in TSA media? - ✔✔Lecithin and polysorbate 80, they can
neutralize a wide range of chemicals used for cleaning controlled areas.
✔✔Media Considerations for GFT - ✔✔Each lot of media requires a certificate of
analysis
Media must be stored according to mfg specifications.
Media should be double bagged and should be irradiated to ensure testing with a sterile
product.
Media can be either terminally sterilized and aspectically filled. (aspectically filled is not
recommended)
GFT samples only need to be collected with TSA plus neutralizers
, Single plate method
✔✔Describe Glove Finger Tip testing - ✔✔Do not spray hands with IPA, use a separate
sampling device for each hand, compounding personnel must gently roll fingertip then
thumbs over surface of agar with not over lapping. Carefully place lid or cover using
aseptic technique and seal with parafilm or approved cleanroom tape.
✔✔What are the action levels for glove finger tip testing? - ✔✔>0 after garbing
>3 after media fill
✔✔How often do compounders need to perform garbing competency (including GFT) -
✔✔Category 1 and 2 every 6 months, category 3 every 3 months
✔✔What type of labeling needs to be on the GFT sample? - ✔✔Label on the base of
the plate, Label with personnel identifier, right or left hand, date of testing, and any
additional relevant identifiers.
✔✔What is a negative control media? - ✔✔Negative controls is media that is not
opened and incubated along with the other media samples. The media is suitable if
there is no growth of organisms.
✔✔What is positive control media? - ✔✔Positive control media is media that is
unopened that will be inoculated with microbes at the lab. Positive controls is not the
equivalent to the growth promotion studies.
✔✔How long and what temperatures are required for the GFT and Media fill testing? -
✔✔Incubate for no less than 48 hrs at 30-35 degreed C and then 20-25 degrees C for
no less than 5 days
✔✔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.
GRADED A+
✔✔How many air changes per hour for ISO 8 Class Rooms? - ✔✔The total HEPA-
filtered air change rate must be adequate to maintain ISO Class 8 under dynamic
operating conditions considering the factors listed above
At least 15 ACPH of the total air change rate in a room must come from the HVAC
through HEPA filters located in the ceiling
Rooms where activity levels are high may require more HEPA-filtered ACPH to maintain
ISO Class 8 air quality under dynamic operating conditions
The total ACPH must be documented on the certification report
✔✔How many air changes per hour in an Unclassified SCA? - ✔✔No requirement
✔✔What is the pressure differential requirement for a SCA for non-hazardous drug
compounding? - ✔✔No requirement
✔✔Certification of the classified areas including the PEC must be performed initially,
and recertification must be performed at least every 6 months and must include <USP
797> - ✔✔Airflow testing: Airflow testing is performed to determine acceptability of the
air velocity, the room air exchange rate, and the room pressure differential in doorways
between adjacent rooms to ensure consistent airflow and that the appropriate quality of
air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH
contributed from the PEC, and the total ACPH must be documented on the certification
report.
HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then
leak tested again after installation and as part of recertification.
Total particle count testing: (See 5.1 Total Airborne Particle Sampling.) Total particle
count testing must be performed under dynamic operating conditions using calibrated
electronic equipment.
Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each
PEC during dynamic operating conditions to demonstrate unidirectional airflow and
sweeping action over and away from the preparation(s).
✔✔Does the number of personnel present in each PEC and SEC during total particle-
count tests and dynamic airflow smoke-pattern test need to be documented? - ✔✔Yes
✔✔The microbiological air and surface monitoring program must include - ✔✔1 - viable
impact volumetric airborne particulate sampling
,2- surface sampling
✔✔What are the goals of microbiological air and surface morning program? - ✔✔To
determine whether contamination is present at unacceptable levels and to assess
whether proper personnel practices are being followed, cleaning and disinfecting agents
are effective, and environmental quality is maintained.
✔✔How often does viable air sampling need to be done for entities compounding
category 1 or 2 CSP? - ✔✔At least every 6 months
✔✔How often does viable air sampling need to be done for entities compounding
category 3 CSP? - ✔✔This must be done within 30 days prior to commencement of any
category 3 compounding and at least monthly thereafter
✔✔Active Air Sampling Procedures for Viable Airborne Monitoring - ✔✔1. Follow the
manufacturer's instructions for operation of the impaction air sampler, including
placement of media device(s).
2. Using the impaction air sampler, test at least 1 cubic meter or 1000 L of air from each
location sampled.
3. At the end of each sampling period, retrieve the media device and cover it. Handle
and store media devices to avoid contamination and prevent condensate from dropping
onto the agar during incubation and affecting the accuracy of the cfu reading (e.g.,
invert plates).
4. Incubate the media device at 30°-35° for no less than 48 h. Examine for growth.
Record the total number of discrete colonies of microorganisms on each media device
as cfu per cubic meter of air on an environmental sampling form based on sample type
(i.e., viable air), sample location, and sample date.
5. Then incubate the media device at 20°-25° for no less than 5 additional days.
Examine for growth. Record the total number of discrete colonies of microorganisms on
each media device as cfu per cubic meter of air on an environmental sampling form
based on sample type (i.e., viable air), sample location, and sample date.
6. Alternatively, to shorten the overall incubation period, two sampling media devices
may be collected for each sample location and incubated concurrently.
A. Both media devices could be TSA or one media device could be TSA and the other
fungal media (e.g., malt extract agar [MEA] or Sabouraud dextrose agar [SDA]).
B. Incubate each media device in a separate incubator. Incubate one media device at
30°-35° for no less than 48 h, and incubate the other media device at 20°-25° for no
less than 5 days. If fungal media are used as one of the samples, incubate the fungal
media sample at 20°-25° for no less than 5 days.
C. Count the total number of discrete colonies of microorganisms on each media
,✔✔What are the action levels for Viable Airborne Particle Air Sampling? - ✔✔Iso Class
5 - Greater than 1
Iso Class 7 - Greater than 10
Iso Class 8 - Greater than 100
✔✔Action Levels - ✔✔The quantity of colony forming units (CFU) at which the state of
contamination control is lost, warranting investigation and mitigation of cause.
✔✔Aseptic - ✔✔A state of control, void of unwanted microbial contamination
✔✔CFU - ✔✔A measure of the total number of microorganisms present on a sampling
device after incubation to estimate the total viable microbial inhabitance of an area
sample
✔✔Don - ✔✔to put on garbing materials
✔✔Detection Level - ✔✔The lowest qty or concentration that can be reliably recovered
with a given analytical method
✔✔Growth Promotion - ✔✔A study where an unexposed sampling device is inoculated
with specific microorganisms in specific qty and compared to the expected number of
colony forming units after incubation.
✔✔Irradiated - ✔✔A method of sterilization through controlled exposure to gamma wave
radiation. This is commonly used for sterilizing microbial growth media.
✔✔TSA - ✔✔Tryptic Soy Agar
This is suitable for recovery of both bacterial and fungal organisms
✔✔What neutralizers are in TSA media? - ✔✔Lecithin and polysorbate 80, they can
neutralize a wide range of chemicals used for cleaning controlled areas.
✔✔Media Considerations for GFT - ✔✔Each lot of media requires a certificate of
analysis
Media must be stored according to mfg specifications.
Media should be double bagged and should be irradiated to ensure testing with a sterile
product.
Media can be either terminally sterilized and aspectically filled. (aspectically filled is not
recommended)
GFT samples only need to be collected with TSA plus neutralizers
, Single plate method
✔✔Describe Glove Finger Tip testing - ✔✔Do not spray hands with IPA, use a separate
sampling device for each hand, compounding personnel must gently roll fingertip then
thumbs over surface of agar with not over lapping. Carefully place lid or cover using
aseptic technique and seal with parafilm or approved cleanroom tape.
✔✔What are the action levels for glove finger tip testing? - ✔✔>0 after garbing
>3 after media fill
✔✔How often do compounders need to perform garbing competency (including GFT) -
✔✔Category 1 and 2 every 6 months, category 3 every 3 months
✔✔What type of labeling needs to be on the GFT sample? - ✔✔Label on the base of
the plate, Label with personnel identifier, right or left hand, date of testing, and any
additional relevant identifiers.
✔✔What is a negative control media? - ✔✔Negative controls is media that is not
opened and incubated along with the other media samples. The media is suitable if
there is no growth of organisms.
✔✔What is positive control media? - ✔✔Positive control media is media that is
unopened that will be inoculated with microbes at the lab. Positive controls is not the
equivalent to the growth promotion studies.
✔✔How long and what temperatures are required for the GFT and Media fill testing? -
✔✔Incubate for no less than 48 hrs at 30-35 degreed C and then 20-25 degrees C for
no less than 5 days
✔✔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.
