PTCB CSPT EXAM WITH QUESTIONS AND VERIED ANSWERS ALREADY
GRADED A LATEST UPDATE 2023-2024
Hand Hygiene (Hand Washing) - ANSWER>>wash hand, under fingernails, wrists, up to
elbow for 30 seconds-dry hands and arms with non shedding disposable towel or
electronic hand dryer-sanitize hands with alcohol based hand rub prior to donning
gloves
garbing order - ANSWER>>shoes, head covers, face masks, gown, gloves, then sanitize
gloves with 70% IPA
Labels for Single Compounded Preparations - ANSWER>>Name of ingredients
Amounts of ingredients
BUD and time
Storage Requirements
Identification of compounding personnel
Labels for Batch Produced CSP - ANSWER>>control or lot number
auxiliary label
device specific instructions
vertical hood - ANSWER>>hazardous compounding-air flows vertically
Horizontal Hood - ANSWER>>air flows horizontally across the work area from back to
front
Direct Compounding Area (DCA) - ANSWER>>- a critical area within the hood (ISO
Class 5) where areas are exposed to filtered air; also known as "first air"
Negative Pressure room - ANSWER>>Hazardous materials
,High-efficiency particulate air (HEPA) filters - ANSWER>>remove microbes > 0.3
micrometers
Ante Room - ANSWER>>washing, garbing, product decontamination
Buffer area air change per hour (APCH) - ANSWER>>30 exchanges per hour
ante room air change per hour (APCH) - ANSWER>>ISO 8-20 per hour ISO 7- 30 per
hour
Cleaning of compounding area - ANSWER>>germicidal detergent & water for visible
solids, 70% isopropyl alcohol
ISO Class 5 PEC cleaned - ANSWER>>beginning of each shift, before each batch, every
30 minus when compounding, after spills, contamination
Cleaning of Counters and floors of specific sites - ANSWER>>daily
Cleaning Walls, ceilings, storage shelving: - ANSWER>>monthly
Suface sampling frequency - ANSWER>>every 6 months or significant changes in
procedure
Temperature of CSP areas - ANSWER>>room temperature 20'C(68'F) or cooler
Airborne Particle Testing - ANSWER>>every 6 months or device relocated or serviced
, ISO class 5 Particle Limit for sterile compounding - ANSWER>>3,520 particles that are
0.5 micron or larger
ISO Class 7 Particle Limit for sterile compounding - ANSWER>>352,000 particles that
are 0.5 micron or larger
ISO Class 8 Particle Limit for sterile compounding - ANSWER>>3,520,000 particles that
are 0.5 micron or larger
ISO Class 5 Colony Forming Unit Action Level - ANSWER>>1 (>3)
ISO Class 7 Colony Forming Unit Action Level - ANSWER>>10-(>5)
ISO Class 8 Colony Forming Unit Action Level - ANSWER>>100 (>100)
Risk Level Classification - ANSWER>>Low Risk, Medium Risk, High Risk, Immediate
Use Risk
Low Risk Examples - ANSWER>>-compounding piggybacks or hydration fluids in a ISO
5 laminar flow hood (LVP with KCl and or vitamins)
-Dual Chamber parenteral nutrition container with no more than 2 additives
Medium-risk examples - ANSWER>>-TPN using manual or automated devices
-filling device reservoirs with more than 3 sterile drug products and evacuation of air
before dispensing
-transfer of volumes from multiple ampules or vials into one or more final sterile
containers
High risk examples - ANSWER>>bulk drug containers, sterilization requirements, non-
sterile components
GRADED A LATEST UPDATE 2023-2024
Hand Hygiene (Hand Washing) - ANSWER>>wash hand, under fingernails, wrists, up to
elbow for 30 seconds-dry hands and arms with non shedding disposable towel or
electronic hand dryer-sanitize hands with alcohol based hand rub prior to donning
gloves
garbing order - ANSWER>>shoes, head covers, face masks, gown, gloves, then sanitize
gloves with 70% IPA
Labels for Single Compounded Preparations - ANSWER>>Name of ingredients
Amounts of ingredients
BUD and time
Storage Requirements
Identification of compounding personnel
Labels for Batch Produced CSP - ANSWER>>control or lot number
auxiliary label
device specific instructions
vertical hood - ANSWER>>hazardous compounding-air flows vertically
Horizontal Hood - ANSWER>>air flows horizontally across the work area from back to
front
Direct Compounding Area (DCA) - ANSWER>>- a critical area within the hood (ISO
Class 5) where areas are exposed to filtered air; also known as "first air"
Negative Pressure room - ANSWER>>Hazardous materials
,High-efficiency particulate air (HEPA) filters - ANSWER>>remove microbes > 0.3
micrometers
Ante Room - ANSWER>>washing, garbing, product decontamination
Buffer area air change per hour (APCH) - ANSWER>>30 exchanges per hour
ante room air change per hour (APCH) - ANSWER>>ISO 8-20 per hour ISO 7- 30 per
hour
Cleaning of compounding area - ANSWER>>germicidal detergent & water for visible
solids, 70% isopropyl alcohol
ISO Class 5 PEC cleaned - ANSWER>>beginning of each shift, before each batch, every
30 minus when compounding, after spills, contamination
Cleaning of Counters and floors of specific sites - ANSWER>>daily
Cleaning Walls, ceilings, storage shelving: - ANSWER>>monthly
Suface sampling frequency - ANSWER>>every 6 months or significant changes in
procedure
Temperature of CSP areas - ANSWER>>room temperature 20'C(68'F) or cooler
Airborne Particle Testing - ANSWER>>every 6 months or device relocated or serviced
, ISO class 5 Particle Limit for sterile compounding - ANSWER>>3,520 particles that are
0.5 micron or larger
ISO Class 7 Particle Limit for sterile compounding - ANSWER>>352,000 particles that
are 0.5 micron or larger
ISO Class 8 Particle Limit for sterile compounding - ANSWER>>3,520,000 particles that
are 0.5 micron or larger
ISO Class 5 Colony Forming Unit Action Level - ANSWER>>1 (>3)
ISO Class 7 Colony Forming Unit Action Level - ANSWER>>10-(>5)
ISO Class 8 Colony Forming Unit Action Level - ANSWER>>100 (>100)
Risk Level Classification - ANSWER>>Low Risk, Medium Risk, High Risk, Immediate
Use Risk
Low Risk Examples - ANSWER>>-compounding piggybacks or hydration fluids in a ISO
5 laminar flow hood (LVP with KCl and or vitamins)
-Dual Chamber parenteral nutrition container with no more than 2 additives
Medium-risk examples - ANSWER>>-TPN using manual or automated devices
-filling device reservoirs with more than 3 sterile drug products and evacuation of air
before dispensing
-transfer of volumes from multiple ampules or vials into one or more final sterile
containers
High risk examples - ANSWER>>bulk drug containers, sterilization requirements, non-
sterile components
