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PTCB CSDP practice questions

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Question 1Sterile Compounding Equipment, Facilities, and Environmental Monitoring

An anteroom that separates a negative-pressure hazardous drug buffer room from the general pharmacy corridor is classified as which ISO class while compounding is in progress?

  1. ISO Class 6
  2. ISO Class 8 Correct answer.
  3. ISO Class 5
  4. ISO Class 7

Explanation

USP <797> requires the hazardous drug buffer room to be at negative pressure relative to the anteroom, and the anteroom to be at negative pressure relative to the corridor. The anteroom serving a negative-pressure buffer room must maintain at least ISO Class 8 air quality during compounding. The buffer room itself is ISO Class 7, and the direct compounding area is ISO Class 5.

Question 2Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which primary engineering control is designed to protect both the sterile preparation and the operator from exposure to hazardous drugs?

  1. Vertical laminar airflow workbench
  2. Class II biological safety cabinet Correct answer.
  3. Compounding isolator with no external venting
  4. Horizontal laminar airflow workbench

Explanation

A Class II biological safety cabinet provides an ISO Class 5 work area while also containing and exhausting hazardous drug aerosols away from the operator. Open-front laminar airflow workbenches protect the preparation but direct air toward the operator, so they are unsuitable for hazardous drugs. A closed isolator can be used for hazardous drugs only if it is configured with appropriate venting and pressure control.

Question 3Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A compounding technician must verify that a new Class II biological safety cabinet has been certified. Which standard governs the certification of this device?

  1. USP <800>
  2. NSF/ANSI 49 Correct answer.
  3. ASHRAE 110
  4. ISO 14644-1

Explanation

NSF/ANSI 49 is the standard used to certify Class II biological safety cabinets, and certification must be repeated at least every 6 months and after relocation or repair. ISO 14644-1 addresses cleanroom classification by particle count, not cabinet certification. ASHRAE 110 is a fume hood containment test method and does not certify biological safety cabinets.

Question 4Sterile Compounding Equipment, Facilities, and Environmental Monitoring

How often must a primary engineering control used for sterile compounding be certified under USP <797>?

  1. Every 3 months
  2. Every 12 months
  3. Every 6 months Correct answer.
  4. Every 24 months

Explanation

USP <797> requires certification of primary engineering controls at least every 6 months, and also after installation, relocation, or major repair. Certification confirms the device maintains the required ISO Class 5 conditions. More frequent certification may be required by policy but the minimum standard is 6 months.

Question 5Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A buffer room is certified as ISO Class 7. Which particle size and concentration limit applies to that classification at rest and in operation under ISO 14644-1?

  1. No more than 3,520 particles per cubic meter of 0.5 micrometer or larger
  2. No more than 352,000 particles per cubic meter of 0.5 micrometer or larger Correct answer.
  3. No more than 352 particles per cubic meter of 0.5 micrometer or larger
  4. No more than 35,200 particles per cubic meter of 0.5 micrometer or larger

Explanation

ISO Class 7 permits no more than 352,000 particles per cubic meter at 0.5 micrometer and larger. ISO Class 8 allows 3,520,000, ISO Class 6 allows 35,200, and ISO Class 5 allows 3,520 at that size. The values differ by factors of ten between adjacent classes.

Question 6Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which document should be consulted to determine the required air changes per hour for a sterile compounding buffer room?

  1. The pharmacy technician certification handbook
  2. USP <797> Correct answer.
  3. The facility's policy manual only
  4. The manufacturer's package insert for the sterile diluent

Explanation

USP <797> specifies engineering control requirements for sterile compounding facilities, including air changes per hour for buffer rooms and anteareas. Manufacturer inserts address product handling, not room ventilation. Facility policy may be stricter but must be built on the USP requirement.

Question 7Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A pharmacy is designing a room for low-risk sterile compounding with a single ISO Class 5 primary engineering control. What is the minimum required air quality classification for the buffer room under USP <797>?

  1. ISO Class 6
  2. ISO Class 7 Correct answer.
  3. ISO Class 5
  4. ISO Class 8

Explanation

The buffer room housing a primary engineering control for sterile compounding must be at least ISO Class 7. The ISO Class 5 requirement applies to the direct compounding area within the PEC. ISO Class 8 applies to certain anteareas, not the buffer room.

Question 8Sterile Compounding Equipment, Facilities, and Environmental Monitoring

What is the primary purpose of maintaining a pressure differential between a hazardous drug buffer room and its adjacent spaces?

  1. To prevent migration of hazardous drug contamination into adjacent areas Correct answer.
  2. To increase the airflow velocity at the direct compounding area
  3. To satisfy fire code requirements for pharmacy rooms
  4. To reduce energy consumption of the HVAC system

Explanation

A hazardous drug buffer room is kept at negative pressure relative to adjacent spaces so that air flows inward and contaminants do not escape. The anteroom is also negative relative to the corridor, creating a cascading pressure gradient. Energy efficiency and fire codes are not the rationale for this design.

Question 9Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which environmental monitoring method is used to detect viable microorganisms on surfaces in a compounding buffer room?

  1. Pressure differential monitoring
  2. Non-viable particle counting
  3. Airflow visualization with smoke
  4. Surface sampling with contact plates or swabs Correct answer.

Explanation

Viable surface monitoring uses contact plates, swabs, or similar sampling devices that are incubated to detect microbial growth. Non-viable particle counting measures inert particles and does not detect organisms. Smoke studies and pressure monitoring evaluate airflow patterns and containment, not microbial contamination.

Question 10Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A compounding facility performs viable air monitoring using an active air sampler. Where should the sample be collected to assess the direct compounding area?

  1. At the return air grille of the buffer room
  2. At the floor drain of the buffer room
  3. In the corridor outside the anteroom
  4. Near the critical work site within the primary engineering control Correct answer.

Explanation

Viable air samples should be collected near the critical work site inside the ISO Class 5 environment to reflect conditions where sterile preparations are exposed. Sampling at return grilles, corridors, or drains assesses other zones and does not represent the direct compounding area.

Question 11Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which class of fire extinguisher is required in a pharmacy area where flammable sterilizing agents are stored?

  1. Class A
  2. Class C
  3. Class D
  4. Class B Correct answer.

Explanation

Class B extinguishers are intended for flammable liquids, which is the hazard presented by flammable sterilizing agents. Class A covers ordinary combustibles, Class C covers energized electrical equipment, and Class D covers combustible metals.

Question 12Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A pharmacy uses an isolator for sterile compounding. Which feature is essential to maintain the ISO Class 5 environment inside the isolator?

  1. A negative pressure with unfiltered exhaust
  2. A continuous positive pressure with HEPA-filtered air supply Correct answer.
  3. An open front that allows unrestricted operator access
  4. A passive vent that relies on room air exchange

Explanation

An isolator maintains its internal ISO Class 5 environment by supplying HEPA-filtered air under positive pressure and by using gloves and transfer chambers to avoid opening the critical zone. An open front would compromise the internal environment. Unfiltered exhaust or passive venting would not maintain the required air quality.

Question 13Sterile Compounding Equipment, Facilities, and Environmental Monitoring

What is the purpose of a smoke study in a sterile compounding facility?

  1. To measure the number of non-viable particles in the air
  2. To verify airflow patterns and unidirectional airflow at the critical site Correct answer.
  3. To confirm the sterility of compounded preparations
  4. To test the HEPA filter for pinhole leaks

Explanation

A smoke study visualizes airflow to confirm that unidirectional air sweeps across the critical site and that no turbulence or dead zones compromise sterility. Particle counting quantifies airborne particles, HEPA leak testing uses a photometer or particle counter at the filter face, and sterility testing evaluates the finished preparation.

Question 14Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A pharmacy technician notices that the pressure differential gauge on the hazardous drug buffer room reads positive relative to the anteroom. What is the most appropriate action?

  1. Continue compounding because the anteroom is still negative to the corridor
  2. Stop compounding and notify the supervisor to investigate the pressure failure Correct answer.
  3. Open the buffer room door to equalize the pressure
  4. Document the reading and recheck it at the next shift

Explanation

A hazardous drug buffer room must be negative relative to its anteroom; a positive reading indicates loss of containment, so compounding must stop until the problem is corrected. Continuing work, propping the door, or delaying action risks contaminating adjacent areas and exposes staff. The deviation should be investigated and documented after containment is restored.

Question 15Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which of the following is a required component of the documentation for environmental monitoring in a sterile compounding facility?

  1. The names of patients who received compounded preparations
  2. The wholesale acquisition cost of the compounded drugs
  3. The sampling locations, methods, results, and corrective actions Correct answer.
  4. The manufacturer's lot numbers for the PEC filters only

Explanation

Environmental monitoring records must capture where and how samples were taken, the results obtained, and any corrective actions taken in response to excursions. Patient identities, drug costs, and filter lot numbers alone do not fulfill the monitoring documentation requirement.

Question 16Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A buffer room's viable air monitoring results exceed the established action level. What is the most appropriate initial response?

  1. Discard all compounded preparations made in the last year
  2. Perform a root cause investigation and implement corrective actions Correct answer.
  3. Increase the compounding volume to dilute the contamination
  4. Repeat the sample immediately without any other action

Explanation

An action-level excursion requires investigation of the cause, such as airflow, cleaning, or personnel practices, followed by corrective actions and follow-up monitoring. Simply repeating the sample ignores the underlying problem, and discarding a year of preparations is disproportionate. Increasing production does not address contamination.

Question 17Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which practice best preserves unidirectional airflow at the direct compounding area of a laminar airflow workbench?

  1. Working with the workbench blower turned off during preparation
  2. Placing supplies between the HEPA filter and the critical site
  3. Arranging items so that air flows from the filter directly over the critical site Correct answer.
  4. Storing bulky equipment at the back of the workbench

Explanation

Unidirectional airflow must move from the HEPA filter across the critical site without obstruction. Placing supplies between the filter and the critical site creates turbulence and contamination risk. Storing bulky items in the airflow path or turning off the blower defeats the engineering control.

Question 18Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which type of water is required for compounding sterile preparations that will be terminally sterilized?

  1. Sterile water for injection
  2. Purified water Correct answer.
  3. Bacteriostatic water for injection
  4. Tap water

Explanation

Purified water is acceptable for compounding sterile preparations that will be terminally sterilized, provided it meets the appropriate chemical purity standards. Tap water is not acceptable for compounding. Sterile water for injection is used when the preparation will not be terminally sterilized or when a sterile vehicle is required. Bacteriostatic water contains a preservative and is not appropriate for all sterile compounding.

Question 19Sterile Compounding Equipment, Facilities, and Environmental Monitoring

What is the purpose of a HEPA filter in a primary engineering control?

  1. To remove airborne particles and microorganisms from the air Correct answer.
  2. To remove chemical vapors from the air
  3. To cool the air to prevent drug degradation
  4. To humidify the air entering the work area

Explanation

HEPA filters remove at least 99.97 percent of airborne particles 0.3 micrometer and larger, which includes most microorganisms and particulate contamination. They do not remove chemical vapors, and they do not humidify or cool the air as a primary function.

Question 20Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A new cleanroom is being qualified. Which test confirms that the HEPA filters are properly installed and free of leaks?

  1. Pressure differential test
  2. Airflow visualization
  3. Viable surface sampling
  4. HEPA filter leak test Correct answer.

Explanation

A HEPA filter leak test, often performed with an aerosol photometer or particle counter, checks the filter media, frame, and seals for leaks. Airflow visualization assesses airflow patterns, pressure testing verifies room containment, and surface sampling detects microbial contamination on surfaces.

Question 21Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which of the following is an appropriate cleaning agent for surfaces in a sterile compounding buffer room?

  1. Bleach alone with no rinsing
  2. A quaternary ammonium compound followed by sterile 70 percent isopropyl alcohol Correct answer.
  3. A phenolic disinfectant applied without contact time
  4. Tap water and dish soap

Explanation

Buffer room surfaces are typically cleaned with a detergent or disinfectant and then wiped with sterile 70 percent isopropyl alcohol to remove residue and reduce microbial load. Bleach must be used with proper dilution and rinsing, tap water and dish soap are not appropriate for controlled environments, and disinfectants must be allowed the required contact time.

Question 22Sterile Compounding Equipment, Facilities, and Environmental Monitoring

What is the minimum required frequency for surface sampling of the direct compounding area in a sterile compounding facility?

  1. Annually
  2. Daily
  3. Weekly
  4. Monthly Correct answer.

Explanation

USP <797> requires surface sampling of the direct compounding area at least monthly, with additional sampling after significant events such as construction or remediation. Daily and weekly intervals are more frequent than the minimum, and annual sampling is far too infrequent.

Question 23Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A pharmacy technician is preparing to compound in a biological safety cabinet. Which action best supports the engineering control's ability to protect the preparation?

  1. Working at least 6 inches inside the front edge of the work area Correct answer.
  2. Turning off the blower to reduce noise during preparation
  3. Blocking the front grille with supplies to save space
  4. Placing the hands and supplies downstream of the critical site

Explanation

Working well inside the cabinet, typically at least 6 inches from the front edge, keeps the critical site within the clean airflow and away from the more turbulent front zone. Blocking the front grille disrupts airflow and containment, and hands or supplies should not be placed downstream of the critical site. The blower must remain on during compounding.

Question 24Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which environmental condition is monitored to confirm that a hazardous drug buffer room remains at negative pressure relative to the anteroom?

  1. Relative humidity
  2. Pressure differential Correct answer.
  3. Particle count
  4. Air changes per hour

Explanation

Pressure differential monitoring directly confirms that the buffer room is negative relative to adjacent spaces, which is the containment requirement. Air changes per hour, humidity, and particle counts are important environmental parameters but do not confirm pressure relationships.

Question 25Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A facility is evaluating whether to use a compounding isolator instead of a biological safety cabinet for hazardous drug preparation. Which consideration is most important?

  1. The isolator must be vented appropriately and maintain negative pressure to contain hazardous drugs Correct answer.
  2. The isolator must use unfiltered room air for ventilation
  3. The isolator must be operated with the gloves removed
  4. The isolator must be placed in an ISO Class 8 room only

Explanation

An isolator used for hazardous drugs must be configured with appropriate venting and negative pressure so that hazardous aerosols and vapors are contained and exhausted safely. Gloves must remain intact during use, and the isolator is placed in a controlled environment that meets the applicable classification. Unfiltered room air would not maintain the required internal air quality.

Question 26Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which particle size range is used to classify a cleanroom as ISO Class 5 under the standard cleanroom classification scheme?

  1. Total airborne particles of every size combined
  2. Particles 0.5 micrometer and larger Correct answer.
  3. Particles 5.0 micrometers and larger
  4. Particles 0.1 micrometer and larger only

Explanation

ISO cleanroom classes are defined by the maximum permitted concentration of airborne particles at a specified size, and ISO Class 5 is expressed using particles of 0.5 micrometer and larger. Particles of 5.0 micrometers are used for the less stringent classes, not for ISO Class 5.

Question 27Sterile Compounding Equipment, Facilities, and Environmental Monitoring

In a horizontal laminar airflow workbench, in which direction does the filtered air move across the direct compounding area?

  1. Vertically downward from the ceiling of the hood
  2. Horizontally from the back of the workbench toward the operator Correct answer.
  3. In a circular pattern around the preparation
  4. Horizontally from the operator toward the back of the workbench

Explanation

A horizontal laminar airflow workbench discharges HEPA-filtered air from the back wall and sweeps it horizontally toward the front, bathing the critical site in first-pass air. Because the air travels toward the operator, the operator must not block the path between the filter and the preparation.

Question 28Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which device is used to continuously measure and record the pressure difference between a buffer room and its adjacent ante room?

  1. A thermohygrometer
  2. A particle counter
  3. A velocity anemometer
  4. A differential pressure gauge Correct answer.

Explanation

A differential pressure gauge (magnehelic gauge) measures the pressure difference between two spaces and is used to confirm that the buffer room maintains the required pressure relationship with adjacent areas. Anemometers measure airflow velocity and particle counters measure airborne particulates, not pressure.

Question 29Sterile Compounding Equipment, Facilities, and Environmental Monitoring

What is the main reason HEPA-filtered supply air is delivered as unidirectional flow in a primary engineering control?

  1. To sweep contaminants away from the critical site without mixing Correct answer.
  2. To reduce the noise level inside the hood
  3. To increase the particle count in the work area
  4. To lower the humidity inside the work area

Explanation

Unidirectional airflow delivers a steady stream of filtered air that pushes particles away from the critical site rather than allowing them to mix and settle there. This first-pass air protection is why obstructions in the airflow path are avoided.

Question 30Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A technician is assigned to perform daily checks at the start of a compounding shift. Which set of readings should be documented before compounding begins?

  1. Only the temperature of the storage refrigerator
  2. Only the humidity of the general pharmacy area
  3. Pressure differentials and temperature/humidity of the buffer room Correct answer.
  4. Only the particle count of the ante room

Explanation

Each shift, compounding personnel verify and record the pressure differentials between the buffer room and adjacent spaces along with temperature and humidity, since these conditions affect the environment and drug stability. Particle counts are performed on a periodic certification and monitoring schedule rather than as a daily shift check.

Question 31Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A cleanroom certification report shows that the HEPA filter in a biological safety cabinet has a small pinhole leak in the filter media. Which corrective action is appropriate?

  1. Increase the room air changes per hour
  2. Continue use because a pinhole leak is acceptable
  3. Reduce the airflow velocity to seal the leak
  4. Repair or replace the HEPA filter and recertify the unit Correct answer.

Explanation

A leak in HEPA filter media compromises the sterility of the airflow and must be corrected by repairing or replacing the filter, followed by recertification to confirm the unit meets requirements. Adjusting room air changes or airflow does not repair a filter defect.

Question 32Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which factor most directly determines the recovery time of a buffer room after a door is opened?

  1. The air changes per hour supplied to the room Correct answer.
  2. The color of the floor coating
  3. The number of staff badges worn in the room
  4. The type of gloves worn by compounding personnel

Explanation

Air changes per hour govern how quickly the room's air volume is replaced and how fast the required pressure and particle conditions recover after a disturbance. Higher air change rates shorten recovery time, while surface finishes and personnel attire do not drive recovery.

Question 33Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A pharmacy plans to store hazardous drugs in a negative-pressure buffer room. Which design element best supports containment of airborne hazardous drug residue?

  1. Recirculating room air through the biological safety cabinet only
  2. Sealing the room and using no exhaust at all
  3. Exhausting room air to the outside after HEPA filtration Correct answer.
  4. Exhausting room air back into the pharmacy without filtration

Explanation

Air from a negative-pressure hazardous drug buffer room should be exhausted to the outside after HEPA filtration so that any airborne hazardous residue is removed from the building rather than recirculated. Recirculation or unfiltered exhaust can spread hazardous contamination.

Question 34Sterile Compounding Equipment, Facilities, and Environmental Monitoring

During a smoke study of a biological safety cabinet, smoke is drawn back toward the front grille instead of flowing smoothly into the work area. What does this pattern most likely indicate?

  1. Correct containment and proper airflow
  2. That the HEPA filter is new
  3. An airflow disturbance or improper balance of supply and exhaust Correct answer.
  4. That the room humidity is too high

Explanation

Smoke visualization confirms whether airflow is unidirectional and properly contained; smoke pulled toward the front grille suggests disrupted airflow or an imbalance that could allow contaminants to escape. The pattern must be corrected and the unit recertified before use.

Question 35Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which document type establishes the written procedures a facility follows for cleaning, monitoring, and maintaining its sterile compounding environment?

  1. A patient counseling record
  2. A material safety data sheet
  3. A purchase order
  4. A standard operating procedure Correct answer.

Explanation

Standard operating procedures describe the facility's approved steps for environmental cleaning, monitoring, and equipment maintenance so that staff perform these tasks consistently. Safety data sheets describe chemical hazards, not facility procedures.

Question 36Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A technician is about to don garb for entry into the buffer room. Which action best preserves the integrity of the controlled environment?

  1. Donning outer garb in the ante room before entering the buffer room Correct answer.
  2. Carrying street shoes into the buffer room
  3. Entering the buffer room directly from the general pharmacy
  4. Donning outer garb inside the buffer room after entry

Explanation

Outer garb such as gowns, shoe covers, and hair covers are donned in the ante room so that contaminants from outside are not carried into the buffer room. Garbing inside the buffer room or bypassing the ante room defeats the purpose of the transition space.

Question 37Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A facility must choose between a ventilated cabinet that protects the product and operator and one that protects only the product. Which consideration is most relevant when compounding hazardous drugs?

  1. Both operator and product protection are needed Correct answer.
  2. Only product protection is needed for hazardous drugs
  3. Neither protection is needed if gloves are worn
  4. Only operator protection is needed for hazardous drugs

Explanation

Hazardous drug compounding requires containment that protects the operator from exposure as well as protecting the sterile product, which is why a ventilated cabinet designed for both is used. Gloves alone do not protect against airborne exposure.

Question 38Sterile Compounding Equipment, Facilities, and Environmental Monitoring

Which practice is required when cleaning and disinfecting the direct compounding area between preparations?

  1. Cleaning only at the end of the day
  2. Wiping from the cleanest area toward the dirtiest area Correct answer.
  3. Spraying disinfectant into the air
  4. Wiping from the dirtiest area toward the cleanest area

Explanation

Surfaces are cleaned from clean to dirty so that contamination is not spread back onto already-cleaned areas. Work proceeds from the critical site outward, and cleaning occurs at defined intervals rather than only at day's end.

Question 39Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A certifier reports that a buffer room's supply air velocity at the HEPA filter face is lower than specified while the room pressure differential remains acceptable. What is the most appropriate interpretation?

  1. The room is fully compliant because pressure is acceptable
  2. The particle counter must be recalibrated
  3. Airflow volume may be inadequate and the system should be evaluated Correct answer.
  4. Lower velocity always improves contamination control

Explanation

Acceptable pressure does not guarantee adequate airflow; low supply velocity can reduce air changes and unidirectional flow, so the HVAC system and filter loading should be evaluated. Compliance requires meeting airflow specifications in addition to pressure relationships.

Question 40Sterile Compounding Equipment, Facilities, and Environmental Monitoring

A facility's environmental monitoring trend shows rising viable particle counts in the buffer room over several months while nonviable counts remain stable. Which explanation is most plausible?

  1. A gradual lapse in cleaning or personnel practices is occurring Correct answer.
  2. The HEPA filters have completely failed
  3. The room pressure has reversed to positive
  4. The particle counter is reading incorrectly

Explanation

Stable nonviable counts indicate that filtration is functioning, so a gradual rise in viable counts points to a practice or cleaning issue such as inadequate disinfection or poor gowning. Investigating personnel and cleaning procedures is the appropriate next step.

Question 41Aseptic Technique and Sterile Compounding Procedures

Before beginning any sterile compounding, a technician performs hand hygiene. Which method is required for routine hand antisepsis prior to donning sterile gloves for a low-risk CSP?

  1. Wipe hands with isopropyl alcohol pads
  2. Rinse hands with sterile water only
  3. Wash with soap and water for 5 seconds
  4. Scrub with an alcohol-based hand rub after washing with soap and water Correct answer.

Explanation

Standard practice is to wash hands with soap and water, dry them, then apply an alcohol-based hand rub before donning sterile gloves. This reduces bioburden on the skin and sustains antimicrobial activity during compounding. A brief rinse or alcohol wipe alone does not achieve adequate antisepsis.

Question 42Aseptic Technique and Sterile Compounding Procedures

Which type of hood is used to prepare hazardous drugs such as antineoplastics?

  1. Clean bench with horizontal airflow
  2. Class II biological safety cabinet Correct answer.
  3. Simple exhaust fume hood
  4. Laminar airflow workbench

Explanation

A Class II biological safety cabinet provides both a sterile work environment and personnel protection by directing air away from the operator and filtering it through HEPA filters. Laminar airflow workbenches protect the product but blow air toward the operator, exposing them to hazardous drug particles.

Question 43Aseptic Technique and Sterile Compounding Procedures

What is the primary purpose of the 70% isopropyl alcohol spray applied to the surface of vials before they enter the hood?

  1. To sterilize the vial and its contents
  2. To dissolve any visible residue on the label
  3. To disinfect the vial's outer surface and reduce contamination Correct answer.
  4. To cool the vial before puncture

Explanation

Isopropyl alcohol is a disinfectant applied to the outer surface of vials and ampules to reduce microbial contamination before they enter the sterile compounding area. It does not sterilize the contents of the vial, which must be preserved by the closed system and aseptic technique.

Question 44Aseptic Technique and Sterile Compounding Procedures

When withdrawing fluid from a vial, which technique best maintains the integrity of the sterile field?

  1. Wipe the needle with alcohol before each puncture
  2. Touch the exposed needle shaft with gloved fingers to steady it
  3. Insert the needle through the center of the disinfected stopper and keep the hub above the fluid Correct answer.
  4. Rest the syringe plunger on the hood surface between steps

Explanation

Aseptic technique requires puncturing the disinfected stopper at its center and keeping the needle hub above the fluid level to avoid contamination from the vial contents. Touching the needle shaft or resting items on the work surface introduces contamination.

Question 45Aseptic Technique and Sterile Compounding Procedures

Which document must be prepared for a CSP that will be administered to more than one patient or that is prepared in batches?

  1. A master formulation record and a compounding record Correct answer.
  2. A single patient label only
  3. A prescription hard copy only
  4. A Material Safety Data Sheet

Explanation

Batch-prepared CSPs require a master formulation record describing the formula and a compounding record documenting each batch. This ensures traceability and reproducibility. A single patient label alone does not document the batch process.

Question 46Aseptic Technique and Sterile Compounding Procedures

A technician notices the HEPA filter in the primary engineering control has a damaged edge seal. What is the appropriate action?

  1. Place a piece of tape over the seal and continue
  2. Stop compounding and report the condition to the supervisor Correct answer.
  3. Increase the airflow and continue
  4. Continue compounding until the end of the shift

Explanation

A damaged HEPA filter or seal compromises the sterile environment and must be corrected before compounding resumes. The technician should stop work and report the condition for repair and recertification. Continuing would risk contaminated CSPs.

Question 47Aseptic Technique and Sterile Compounding Procedures

Which of the following is an example of a critical site in sterile compounding?

  1. The needle tip and the vial stopper Correct answer.
  2. The exterior of a sealed shipping carton
  3. The label on a finished CSP
  4. The outer surface of the hood's glass shield

Explanation

Critical sites are surfaces that, if contaminated, could allow microorganisms to enter the CSP. The needle tip and the punctured vial stopper are critical sites that must be protected from touch and airborne contamination.

Question 48Aseptic Technique and Sterile Compounding Procedures

What is the recommended maximum time a low-risk CSP prepared without preservatives may be stored at room temperature before administration?

  1. 48 hours Correct answer.
  2. 12 hours
  3. 24 hours
  4. 7 days

Explanation

According to USP <797> beyond-use dating for low-risk CSPs stored at room temperature, the maximum is 48 hours. Refrigerated storage allows longer dating. Exceeding the BUD risks administration of a non-sterile or degraded product.

Question 49Aseptic Technique and Sterile Compounding Procedures

When using a closed-system transfer device for hazardous drug preparation, what is the primary benefit?

  1. It prevents the release of hazardous drug aerosols and vapors Correct answer.
  2. It allows compounding without gloves
  3. It replaces the need for disinfection of vial stoppers
  4. It eliminates the need for a biological safety cabinet

Explanation

Closed-system transfer devices contain hazardous drug aerosols and vapors within the system, reducing occupational exposure. They supplement, but do not replace, engineering controls, PPE, and disinfection.

Question 50Aseptic Technique and Sterile Compounding Procedures

A technician is preparing a CSP and must add a small volume of drug to a bag of base solution. Which method minimizes the risk of contamination?

  1. Cut the bag corner and inject the drug
  2. Add the drug to the bag before disinfecting the port
  3. Remove the bag's port cap and pour the drug through the opening
  4. Inject through the disinfected injection port using a sterile needle Correct answer.

Explanation

Injecting through a disinfected injection port with a sterile needle keeps the system closed and minimizes contamination. Opening the bag or cutting it destroys the closed system and introduces contamination.