CSPT Certified Compounded Sterile Preparation Technician Exam — Questions and Answers

Question 1: What type of monitoring device is recommended for CSP storage refrigerators?

No device needed if the refrigerator is new
A calibrated continuous monitoring device with alarm capability (Correct answer)
A standard household thermometer checked weekly
A mercury thermometer checked monthly

Correct answer: A calibrated continuous monitoring device with alarm capability

CSP storage requires calibrated continuous temperature monitoring with alarm capability.

Question 2: Which personnel action is required immediately before beginning aseptic manipulations for a non-sterile to sterile compounding task?

Perform hand hygiene and don sterile gloves using aseptic technique (Correct answer)
Review the patient's medication administration record
Wipe the ISO 5 hood surface with sterile water only
Apply lotion to prevent skin dryness under gloves

Correct answer: Perform hand hygiene and don sterile gloves using aseptic technique

Proper hand hygiene followed by donning sterile gloves using aseptic technique is required immediately before any aseptic manipulation to prevent contamination.

Question 3: When visually inspecting a lipid-containing TPN (3-in-1) admixture, which finding indicates the emulsion has CRACKED and must be discarded?

Small bubbles visible after recent mixing
Separation into a visible oil layer on top (Correct answer)
A uniform creamy-white appearance
A slight yellow tint from multivitamins

Correct answer: Separation into a visible oil layer on top

A visible layer of oil separated on top indicates the emulsion has cracked (irreversibly destabilized) and cannot be safely administered.

Question 4: What does the term 'Category 1 CSP' refer to under the 2023 USP <797> revision?

A CSP prepared exclusively for veterinary use
A CSP compounded in a registered outsourcing facility
A CSP assigned a BUD of 12 hours or less at room temp or 24 hours refrigerated (Correct answer)
A CSP compounded without sterility testing

Correct answer: A CSP assigned a BUD of 12 hours or less at room temp or 24 hours refrigerated

Category 1 CSPs under USP <797> (2023) are assigned BUDs of ≤12 hours at controlled room temperature or ≤24 hours refrigerated.

Question 5: A pharmacy is required to have a designated person responsible for overseeing compliance with USP <800>. Which of the following is a primary responsibility of this individual?

Ensuring competency of personnel and overseeing environmental control of HD areas. (Correct answer)
Performing the final verification of all compounded sterile preparations.
Negotiating drug purchasing contracts with wholesalers.
Conducting annual performance reviews for all pharmacy technicians.

Correct answer: Ensuring competency of personnel and overseeing environmental control of HD areas.

USP <800> requires each entity to have a designated person who is qualified and trained to be responsible for developing procedures, overseeing compliance with the chapter, ensuring personnel competency in handling HDs, and ensuring that the storage and compounding areas are appropriately controlled and monitored.

Question 6: A technician is preparing for a non-sterile to sterile compounding session and needs to ensure the glass vials used will be free of both microbial life and pyrogens. Which piece of equipment is required to achieve this?

Autoclave
Class II Biological Safety Cabinet
Depyrogenating oven (Correct answer)
Incubator

Correct answer: Depyrogenating oven

A depyrogenating oven uses high-temperature dry heat (typically 250°C or higher) to destroy both microorganisms and pyrogens (endotoxins). An autoclave uses steam to sterilize but is not effective at destroying endotoxins. Therefore, for rendering glassware pyrogen-free, a depyrogenating oven is essential.

Question 7: Which type of IV admixture preparation error involves adding the correct drug in the correct amount but to the WRONG patient's bag?

Wrong drug error
Wrong rate error
Wrong patient error (Correct answer)
Labeling error

Correct answer: Wrong patient error

A wrong patient error occurs when a correctly prepared product is assigned or delivered to the wrong patient, often due to insufficient verification during compounding.

Question 8: What is a "media fill test" used for in sterile compounding?

To simulate the compounding process and verify aseptic technique (Correct answer)
To evaluate the taste of compounded oral medications
To measure the potency of compounded medications
To assess the color and clarity of compounded solutions

Correct answer: To simulate the compounding process and verify aseptic technique

Media fill tests are performed to demonstrate that the compounding process can be conducted aseptically.

Question 9: A technician is working with a hazardous drug inside a Compounding Aseptic Containment Isolator (CACI). Which feature is essential for this type of Primary Engineering Control to protect the technician?

Unidirectional vertical airflow only
Negative air pressure relative to the surrounding room (Correct answer)
Positive air pressure relative to the surrounding room
A heated work surface to vaporize spills

Correct answer: Negative air pressure relative to the surrounding room

A Compounding Aseptic Containment Isolator (CACI) is used for hazardous drugs and must maintain negative air pressure. This ensures that in the event of a breach, air from the surrounding room flows into the isolator, preventing hazardous drug particles or vapors from escaping into the cleanroom and protecting the compounder.

Question 10: A technician must prepare a sterile solution from a non-sterile bulk powder known to be heat-labile. Which method of sterilization is most appropriate for the final preparation?

Ethylene oxide gas sterilization
Dry heat sterilization in a depyrogenating oven
Steam sterilization in an autoclave
Sterilization by filtration using a 0.22-micron filter (Correct answer)

Correct answer: Sterilization by filtration using a 0.22-micron filter

Heat-labile substances are damaged by high temperatures, making dry heat and steam sterilization (autoclaving) unsuitable. Sterilization by filtration removes microorganisms by passing the solution through a 0.22-micron filter without using heat, thus preserving the integrity of the drug.

Question 11: What is the primary concern when converting a non-sterile ingredient into a sterile preparation?

The ingredient taste after sterilization
Ensuring complete sterilization while maintaining chemical stability and potency (Correct answer)
Whether the ingredient has been FDA approved
The cost of sterilization equipment

Correct answer: Ensuring complete sterilization while maintaining chemical stability and potency

The primary concern is achieving complete sterility without degrading the drug chemical properties.

Question 12: A patient-specific IV bag is returned to the pharmacy after being sent to a nursing unit. Under which circumstance may this CSP be redispensed to another patient?

If the IV bag is for a common antibiotic that is in short supply.
Under no circumstances; once a CSP leaves the direct control of the pharmacy for a specific patient, it cannot be redispensed to another. (Correct answer)
If the nurse states that the IV bag was never opened or used.
If the tamper-evident seal is still intact and it will be used within the hour.

Correct answer: Under no circumstances; once a CSP leaves the direct control of the pharmacy for a specific patient, it cannot be redispensed to another.

Once a compounded sterile preparation has been labeled for and sent to a specific patient care area, it cannot be returned and redispensed to another patient. The pharmacy can no longer guarantee the proper storage conditions and integrity of the CSP once it has left its control. USP <797> allows for redispensing only if the pharmacy can ensure the CSP remained sterile, pure, and stable, which is virtually impossible after it has been on a patient unit. [6, 7]

Question 13: A compounding technician must prepare 600 mL of a 0.45% NaCl solution using 0.9% NaCl stock and SWFI. How much 0.9% NaCl is needed?

200 mL
450 mL
100 mL
300 mL (Correct answer)

Correct answer: 300 mL

C1V1 = C2V2: 0.9% × V1 = 0.45% × 600 mL → V1 = 300 mL.

Question 14: What is a quality event and how should it be managed?

A celebration when no errors occur
Only triggered by patient complaints
Any occurrence deviating from quality standards, requiring documentation, investigation, root cause analysis, and corrective action (Correct answer)
A marketing event

Correct answer: Any occurrence deviating from quality standards, requiring documentation, investigation, root cause analysis, and corrective action

Quality events include errors, near-misses, environmental excursions, equipment failures, and complaints.

Question 15: Calculate the drip rate for 500 mL over 4 hours using a 15 drops/mL set.

20.8 drops/min
62.5 drops/min
31.3 drops/min (Correct answer)
15.6 drops/min

Correct answer: 31.3 drops/min

500 mL times 15 drops/mL divided by 240 minutes equals 31.25 drops/min.

Question 16: A continuous infusion is ordered at 15 mL/hr. How many hours will a 250 mL bag last?

12.5 hours
15 hours
16.7 hours (Correct answer)
10 hours

Correct answer: 16.7 hours

250 mL ÷ 15 mL/hr ≈ 16.7 hours.

Question 17: How often must wipe sampling for surface contamination be performed in HD handling areas?

Weekly
Daily
Annually
At least every 6 months and when spills occur (Correct answer)

Correct answer: At least every 6 months and when spills occur

USP 800 recommends routine wipe sampling at a minimum of every 6 months to detect surface contamination.

Question 18: Which class of microorganisms is most resistant to chemical disinfection?

Bacterial endospores (Correct answer)
Fungi
Gram-negative bacteria
Enveloped viruses

Correct answer: Bacterial endospores

Bacterial endospores (e.g., Clostridium and Bacillus species) form highly resistant dormant structures that require sporicidal agents or sterilization to destroy.

Question 19: What is the purpose of a medication use evaluation (MUE) for compounded sterile preparations?

To systematically evaluate prescribing, dispensing, and administration patterns to improve quality and safety (Correct answer)
To plan the pharmacy budget
To evaluate medication taste
To negotiate drug pricing

Correct answer: To systematically evaluate prescribing, dispensing, and administration patterns to improve quality and safety

An MUE examines how CSPs are prescribed, prepared, and administered, identifying improvement opportunities.

Question 20: What is the required temperature range for the buffer area in a sterile compounding facility?

20 degrees C or cooler
20 to 25 degrees C (Correct answer)
15 to 20 degrees C
25 to 30 degrees C

Correct answer: 20 to 25 degrees C

The buffer area should maintain controlled room temperature of 20 to 25 degrees C (68 to 77 degrees F).

Question 21: What is the purpose of a pressure differential between the buffer area and the ante-area?

To reduce humidity
To keep temperatures consistent
To increase HEPA filter efficiency
To prevent less clean air from flowing into the cleaner buffer area (Correct answer)

Correct answer: To prevent less clean air from flowing into the cleaner buffer area

A positive pressure differential ensures air flows from the cleaner buffer area outward to the less clean ante-area, preventing contamination.

Question 22: What action should be taken if the primary engineering control (PEC) HEPA filter fails certification during routine testing?

Immediately cease compounding until the filter is repaired or replaced (Correct answer)
Reduce airflow speed to prevent further damage
Continue compounding using extra PPE as a precaution
Notify the pharmacist but continue low-risk compounding only

Correct answer: Immediately cease compounding until the filter is repaired or replaced

USP <797> requires that compounding cease immediately when a PEC fails certification, as sterility of preparations can no longer be assured.

Question 23: A stock solution contains 250 mg/5 mL. How many mL are needed to provide a 75 mg dose?

3 mL
2 mL
1 mL
1.5 mL (Correct answer)

Correct answer: 1.5 mL

Concentration = 50 mg/mL; 75 mg ÷ 50 mg/mL = 1.5 mL.

Question 24: What is the maximum beyond-use date for a Category 1 CSP compounded from sterile hazardous drug components under USP 797?

12 hours at controlled room temperature
48 hours at controlled room temperature
The same BUD as non-hazardous Category 1 CSPs (Correct answer)
24 hours at controlled room temperature

Correct answer: The same BUD as non-hazardous Category 1 CSPs

Hazardous drug status alone does not change the BUD assignment under USP 797. BUDs are determined by compounding category and storage conditions.

Question 25: When performing a media-fill test, what is being evaluated?

The technician aseptic technique and the compounding environment (Correct answer)
The sterility of the HEPA filter
The accuracy of the balance
The potency of the compounded product

Correct answer: The technician aseptic technique and the compounding environment

A media-fill test evaluates the technician aseptic technique and the suitability of the compounding environment by using growth media instead of actual drugs.

Question 26: What is a pass-through chamber used for in a sterile compounding facility?

To provide additional compounding workspace
To transfer materials between areas while minimizing door openings (Correct answer)
To store hazardous waste
For personnel to transition between areas

Correct answer: To transfer materials between areas while minimizing door openings

Pass-through chambers allow materials to be transferred between the ante-area and buffer area without opening the door between the two areas.

Question 27: What is the correct technique for withdrawing medication from a single-dose vial?

Insert needle at 90 degrees without swabbing
Remove cap and pour contents into mixing container
Swab septum with tap water then insert needle
Swab septum with 70% IPA, allow to dry, then insert needle using aseptic technique (Correct answer)

Correct answer: Swab septum with 70% IPA, allow to dry, then insert needle using aseptic technique

The septum must be swabbed with sterile 70% IPA and allowed to dry completely before needle insertion.

Question 28: You need to prepare 250 mL of a 2% lidocaine solution from a 4% stock. How much 4% stock is needed?

175 mL
100 mL
125 mL (Correct answer)
62.5 mL

Correct answer: 125 mL

Using C1V1=C2V2: 4% × V1 = 2% × 250 mL → V1 = 125 mL.

Question 29: What role does the designated person play in quality assurance?

They only perform final product verification
They manage financial accounts
They have overall responsibility for the quality of CSPs including all operations and quality systems (Correct answer)
They only order supplies

Correct answer: They have overall responsibility for the quality of CSPs including all operations and quality systems

The designated person bears overall responsibility for the entire sterile compounding program.

Question 30: Under USP <797>, which of the following CSPs would require a 'single-dose only' or 'discard after use' notation?

Unit-dose syringes without antimicrobial preservatives (Correct answer)
Preparations dispensed in original manufacturer vials
Multi-dose vials with preserved formulations
Batch preparations stored in sealed multi-dose containers

Correct answer: Unit-dose syringes without antimicrobial preservatives

Unpreserved unit-dose syringes must be labeled to indicate they should be discarded after a single use to prevent microbial contamination.

Question 31: What is the correct cleaning progression when disinfecting a sterile compounding suite?

Buffer room → anteroom → ISO 5 area
ISO 5 area → buffer room → anteroom (most to least critical)
Anteroom → buffer room → ISO 5 area (least to most critical) (Correct answer)
ISO 5 area → anteroom → buffer room

Correct answer: Anteroom → buffer room → ISO 5 area (least to most critical)

Cleaning should proceed from least critical (anteroom) to most critical (ISO 5 zone) to avoid tracking contamination into cleaner areas.

Question 32: After compounding a sterile hazardous drug, a technician must dispose of the outer pair of chemotherapy gloves. According to USP <800>, where should these gloves be discarded?

In a red biohazard bag designated for infectious waste.
In a regular trash can located outside the buffer room.
In an approved waste container inside the PEC or a sealable bag for disposal outside the PEC. (Correct answer)
In a sharps container within the Primary Engineering Control (PEC).

Correct answer: In an approved waste container inside the PEC or a sealable bag for disposal outside the PEC.

USP <800> specifies that all PPE worn when handling HDs is considered contaminated. Chemotherapy gloves used during compounding must be discarded in a waste container approved for trace-contaminated waste located inside the Primary Engineering Control (PEC). Alternatively, they can be placed in a sealable bag inside the PEC and then discarded in an appropriate container outside the PEC.

Question 33: What is the purpose of the "beyond-use date" (BUD) in compounded sterile preparations?

To show the date the product was compounded
To specify the date by which the compounded preparation should not be used (Correct answer)
To highlight the expiration date of the ingredients used
To indicate the date by which a product should be administered

Correct answer: To specify the date by which the compounded preparation should not be used

The BUD indicates the last date that the compounded preparation is expected to remain safe and effective for use.

Question 34: A 250 mL NS bag contains 500 mg of ciprofloxacin. After 100 mL has infused, how many mg of drug remain in the bag?

400 mg
200 mg
300 mg (Correct answer)
100 mg

Correct answer: 300 mg

500 mg ÷ 250 mL = 2 mg/mL; 150 mL remain × 2 mg/mL = 300 mg.

Question 35: A drug has an osmolarity of 1500 mOsm/L. If diluted to 500 mL with D5W, what is the approximate osmolarity?

500 mOsm/L
1000 mOsm/L
750 mOsm/L (Correct answer)
250 mOsm/L

Correct answer: 750 mOsm/L

1500 mOsm/L × 1 L ÷ 2 (500 mL dilution) → 750 mOsm/L approximate midpoint.

Question 36: A biological safety cabinet (BSC) Class II Type A2 used for hazardous drug compounding differs from a standard LAFW primarily because it:

Provides only product protection with no operator protection
Operates under positive pressure to protect the product from room air
Uses UV light instead of HEPA filtration for sterilization
Recirculates filtered air internally and exhausts a portion to the outside, protecting both product and operator (Correct answer)

Correct answer: Recirculates filtered air internally and exhausts a portion to the outside, protecting both product and operator

A Class II Type A2 BSC recirculates approximately 70% of air through a HEPA filter within the cabinet and exhausts 30% to the outside, providing both product and personnel protection.

Question 37: Which regulatory body primarily governs the disposal of hazardous pharmaceutical waste (including chemotherapy drugs) in the United States?

The Occupational Safety and Health Administration (OSHA)
The Drug Enforcement Administration (DEA)
The Food and Drug Administration (FDA)
The Environmental Protection Agency (EPA) under RCRA (Correct answer)

Correct answer: The Environmental Protection Agency (EPA) under RCRA

The EPA regulates hazardous waste disposal under the Resource Conservation and Recovery Act (RCRA). Many chemotherapy drugs are classified as RCRA hazardous waste (P-listed or U-listed). States may have additional or more stringent regulations, but EPA/RCRA is the federal framework governing hazardous pharmaceutical waste disposal.

Question 38: Which of the following correctly describes a 503B outsourcing facility under federal law as distinguished from a 503A pharmacy?

503B facilities are exempt from USP <797> requirements
503B facilities operate exclusively under state pharmacy board oversight
503B facilities may compound large batches without patient-specific prescriptions and are FDA-registered (Correct answer)
503B facilities may compound only for specific identified patients with a prescription

Correct answer: 503B facilities may compound large batches without patient-specific prescriptions and are FDA-registered

Section 503B outsourcing facilities, registered with the FDA under the DQSA, may compound large volumes without patient-specific prescriptions and are subject to federal cGMP oversight.

Question 39: Which of the following best describes the function of the anteroom in a sterile compounding facility?

It houses the primary engineering control for sterile compounding
It is used exclusively for storage of compounded preparations
It serves as a transition zone where personnel don PPE and maintain a pressure differential buffer (Correct answer)
It is where final product labeling and QA checks are performed

Correct answer: It serves as a transition zone where personnel don PPE and maintain a pressure differential buffer

The anteroom is a transitional space used for gowning, hand hygiene, and maintaining a pressure gradient between unclassified and classified areas.

Question 40: What is the minimum recommended time a LAFW or BSC should run before use to purge the work zone with HEPA-filtered air?

10 minutes
60 minutes
30 minutes (Correct answer)
5 minutes

Correct answer: 30 minutes

USP <797> recommends running the LAFW or BSC for at least 30 minutes before compounding to ensure the work zone is adequately purged with HEPA-filtered air.

Question 41: Which electrolyte is most critical to monitor in patients receiving long-term total parenteral nutrition (TPN) due to the risk of refeeding syndrome?

Sodium
Calcium
Chloride
Phosphate (Correct answer)

Correct answer: Phosphate

Phosphate drops precipitously during refeeding syndrome as cells take up phosphate rapidly during anabolism, making it the most critical electrolyte to monitor.

Question 42: Which of the following best describes a 'corrective and preventive action' (CAPA) in sterile compounding QA?

A standard procedure for reconstituting lyophilized drugs
A log of all medications dispensed from the cleanroom
A checklist used during daily cleaning of the ISO 5 hood
A documented process to identify root causes of deviations and prevent recurrence (Correct answer)

Correct answer: A documented process to identify root causes of deviations and prevent recurrence

CAPA is a quality management tool that investigates the root cause of a nonconformance (corrective) and implements system changes to prevent it from happening again (preventive).

Question 43: You are preparing an IV admixture and need to add calcium gluconate 1 g. The available vial is 10% (100 mg/mL). How many mL do you draw up?

10 mL (Correct answer)
1 mL
5 mL
100 mL

Correct answer: 10 mL

1 g = 1000 mg; 1000 mg ÷ 100 mg/mL = 10 mL.

Question 44: To achieve initial qualification for aseptic compounding, a technician must successfully pass a gloved fingertip and thumb sampling test. According to USP <797>, what is the maximum acceptable Colony-Forming Unit (CFU) count for this initial competency evaluation?

Zero CFUs on both hands. (Correct answer)
Less than or equal to 3 CFUs on one hand.
Less than or equal to 1 CFU on each hand.
A total of 5 CFUs for both hands combined.

Correct answer: Zero CFUs on both hands.

For the initial competency evaluation in garbing and hand hygiene, USP <797> requires a result of zero CFUs across three separate, successful sampling events. The action level of >3 CFUs applies to subsequent, routine sampling that occurs after a media-fill test, not the initial qualification.

Question 45: A hospital pharmacy is preparing a large batch of a heat-stable electrolyte solution from bulk, non-sterile powders. The plan is to terminally sterilize the CSPs after they have been packaged into their final sealed glass vials. What is the most common and effective method for this process?

Irradiation with ultraviolet (UV) light
Aseptic filtration into the vials
Dry heat sterilization
Steam sterilization (autoclaving) (Correct answer)

Correct answer: Steam sterilization (autoclaving)

Terminal sterilization is the process of sterilizing a product in its final, sealed container. For aqueous (water-based), heat-stable solutions, steam sterilization (autoclaving) is the preferred and most common method. It provides a high level of sterility assurance. Filtration is a sterilization method but occurs before packaging and is not considered terminal sterilization.

Question 46: Which sterilization method is appropriate for a heat-labile drug solution?

Dissolution followed by 0.22-micron sterilizing filtration (Correct answer)
Ultraviolet light exposure for 30 minutes
Dry heat sterilization at 180 degrees C
Autoclaving at 121 degrees C for 20 minutes

Correct answer: Dissolution followed by 0.22-micron sterilizing filtration

Heat-labile drugs are sterilized by dissolving in solvent and filtering through a 0.22-micron sterilizing filter.

Question 47: When compounding a 3-in-1 TPN admixture, what is the CORRECT order of component addition to minimize the risk of calcium-phosphate precipitation?

Calcium → Phosphate → Dextrose → Amino acids → Lipids
Lipids → Calcium → Phosphate → Amino acids → Dextrose
Dextrose → Phosphate → Amino acids → Calcium → Lipids (Correct answer)
Phosphate → Calcium → Amino acids → Dextrose → Lipids

Correct answer: Dextrose → Phosphate → Amino acids → Calcium → Lipids

Adding dextrose first, then phosphate followed by amino acids and calcium last (before lipids) ensures the components are well-diluted before potentially reactive ions meet.

Question 48: Which organism, if recovered during surface sampling in a sterile compounding area, would be of GREATEST concern due to its resistance to disinfectants and heat?

Staphylococcus epidermidis
Bacillus spores (Correct answer)
Candida albicans
Micrococcus luteus

Correct answer: Bacillus spores

Bacillus spores are highly resistant to disinfectants and heat, making them particularly dangerous in sterile compounding environments and difficult to eliminate.

Question 49: A compounding technician has finished preparing a hazardous drug IV admixture. The used IV bag, tubing set, and gloves are considered trace chemotherapy waste. How should this waste be disposed of?

In a standard yellow biohazard bag in the regular trash
Flushed down the sink drain with large amounts of water
In a sharps container regardless of whether sharps are present
In a properly labeled chemotherapy (black or yellow) waste container designated for trace chemo waste, segregated from regular trash and biohazardous waste (Correct answer)

Correct answer: In a properly labeled chemotherapy (black or yellow) waste container designated for trace chemo waste, segregated from regular trash and biohazardous waste

Trace chemotherapy waste must be placed in appropriately labeled, closeable chemo waste containers (often yellow or black with chemotherapy labels) and segregated from regular trash and infectious waste. Flushing to drain or placing in standard trash is prohibited and constitutes an environmental violation under RCRA.

Question 50: Which type of container is preferred to minimize oxidative degradation when assigning a BUD to a light-sensitive CSP?

Clear glass vial
Stainless steel container
Amber vial or foil overwrap (Correct answer)
Polypropylene bag

Correct answer: Amber vial or foil overwrap

Amber vials or foil overwraps block UV and visible light, reducing photodegradation and supporting a longer BUD.

Question 51: When disinfecting a laminar airflow workbench (LAFW), in which direction should the technician wipe the work surface?

From front to back in a single continuous motion
From back to front in overlapping, side-to-side strokes (Correct answer)
In circular motions starting from the center outward
From left to right only, avoiding the HEPA filter

Correct answer: From back to front in overlapping, side-to-side strokes

Wiping from back to front using overlapping side-to-side strokes moves contamination away from the HEPA filter toward the operator, preventing recontamination of the clean zone.

Question 52: An order is written for a patient weighing 165 lbs to receive a drug at a dose of 2 mg/kg. The drug is available in a vial with a concentration of 10 mg/mL. How many mL should be administered?

7.5 mL
33 mL
16.5 mL
15 mL (Correct answer)

Correct answer: 15 mL

First, convert the patient's weight from pounds (lbs) to kilograms (kg): 165 lbs / 2.2 lbs/kg = 75 kg. Next, calculate the total dose in mg: 75 kg * 2 mg/kg = 150 mg. Finally, calculate the volume in mL to administer: 150 mg / 10 mg/mL = 15 mL.

Question 53: During a sterile compounding procedure, a technician accidentally touches the needle tip to their gloved finger before puncturing the vial. According to USP <797> principles, what is the most appropriate immediate action?

Continue with the procedure as the gloves are sterile.
Wipe the needle with a sterile 70% isopropyl alcohol wipe.
Visually inspect the needle for contamination before proceeding.
Discard the needle and syringe and start over with new sterile supplies. (Correct answer)

Correct answer: Discard the needle and syringe and start over with new sterile supplies.

The tip of the needle is a critical site and must remain sterile at all times. Touching it, even with a sterile glove, compromises its sterility. Wiping the needle is not sufficient to re-sterilize it. The only acceptable action under USP <797> aseptic technique principles is to discard the contaminated needle and syringe and begin again with new, sterile ones to prevent patient harm.

Question 54: In a non-hazardous sterile compounding cleanroom suite, what is the primary reason for maintaining a positive pressure differential between the buffer area and the ante-area?

To prevent airborne contaminants from entering the cleaner buffer area (Correct answer)
To reduce energy consumption of the HVAC system
To ensure easier opening and closing of doors
To concentrate the effectiveness of cleaning agents

Correct answer: To prevent airborne contaminants from entering the cleaner buffer area

Positive pressure ensures that air flows from cleaner spaces (the buffer area) to less clean spaces (the ante-area). This airflow pattern acts as a barrier, preventing particles and microorganisms from the ante-area from entering the critical buffer area where compounding occurs.

Question 55: Which of the following is a critical aspect of maintaining sterility during the compounding process?

Using only single-use disposable equipment
Performing all tasks within a designated laminar airflow hood
Working quickly to reduce time spent in the cleanroom
Minimizing hand movements and avoiding unnecessary contact with sterile surfaces (Correct answer)

Correct answer: Minimizing hand movements and avoiding unnecessary contact with sterile surfaces

Minimizing hand movements and avoiding contact with sterile surfaces helps prevent contamination.

Question 56: What is the primary difference between a horizontal LAFW and a vertical LAFW?

Vertical LAFWs cannot be used for sterile compounding
Horizontal LAFWs use ULPA filters
In a horizontal LAFW air flows back to front; in a vertical LAFW air flows top to bottom (Correct answer)
Horizontal LAFWs are larger

Correct answer: In a horizontal LAFW air flows back to front; in a vertical LAFW air flows top to bottom

The key difference is airflow direction: horizontal LAFWs push air from the back wall toward the technician, while vertical LAFWs direct air downward from the top.

Question 57: The minimum recommended air changes per hour (ACPH) for an ISO 7 buffer room under USP <797> is:

20 ACPH
60 ACPH
30 ACPH (Correct answer)
12 ACPH

Correct answer: 30 ACPH

USP <797> requires a minimum of 30 ACPH of HEPA-filtered air in ISO 7 buffer rooms to maintain proper air quality.

Question 58: Which of the following pieces of equipment is classified as a Primary Engineering Control (PEC)?

A cleanroom refrigerator
An automated compounding device (ACD)
A pass-through chamber
A Compounding Aseptic Isolator (CAI) (Correct answer)

Correct answer: A Compounding Aseptic Isolator (CAI)

A Primary Engineering Control (PEC) is a device that provides an ISO Class 5 environment for sterile compounding. A Compounding Aseptic Isolator (CAI) is a type of PEC, along with Laminar Airflow Workbenches (LAFWs) and Biological Safety Cabinets (BSCs). The other options are support equipment found within the cleanroom suite but are not PECs.

Question 59: What is the significance of an 'inhibitory residue test' for cleaning agents used in sterile compounding areas?

It confirms the cleaning agent kills 99.9% of bacteria
It ensures the cleaning agent is compatible with ISO 5 requirements
It measures how quickly the surface dries after cleaning
It verifies that cleaning agent residues will not interfere with sterility testing results (Correct answer)

Correct answer: It verifies that cleaning agent residues will not interfere with sterility testing results

Inhibitory residue testing ensures cleaning agent residues left on compounding surfaces will not falsely suppress microbial growth in sterility tests, ensuring accurate results.

Question 60: According to USP Chapter <800>, which of the following is a primary engineering control (PEC) specifically designed for compounding sterile hazardous drugs?

Compounding Aseptic Isolator (CAI)
Laminar Airflow Workbench (LAFW)
Containment Segregated Compounding Area (C-SCA)
Biological Safety Cabinet (BSC) (Correct answer)

Correct answer: Biological Safety Cabinet (BSC)

USP <800> requires that sterile hazardous drugs be compounded in a primary engineering control (PEC) that provides personnel protection. A Class II or III Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI) are the appropriate choices. A Laminar Airflow Workbench (LAFW) provides product protection but not personnel protection from hazardous drug exposure. A CAI is for non-hazardous drugs. A C-SCA is a type of secondary engineering control, not a primary one.

Question 61: How often should HEPA filters in a laminar airflow workbench be certified?

Monthly
Quarterly
Annually
Every 6 months (Correct answer)

Correct answer: Every 6 months

HEPA filters in LAFWs and other PECs must be certified at least every 6 months.

Question 62: When a CSP is prepared in multiple containers from one compounding record, what must appear on each individual container label?

The compounder's name and dispensing date only
All required label elements including lot number, BUD, and strength (Correct answer)
Only the lot number
A cross-reference to the master formula sheet only

Correct answer: All required label elements including lot number, BUD, and strength

Each individual container must bear a complete label with all required elements so it can stand alone as a fully identified preparation.

Question 63: What is the significance of the 'overage' calculation when compounding a non-sterile API into a sterile preparation?

Overage is calculated to increase the beyond-use date
Overage eliminates the need for sterility testing
Overage is added to compensate for filtration-related volume loss only
Overage accounts for API degradation during sterilization to ensure label claim potency (Correct answer)

Correct answer: Overage accounts for API degradation during sterilization to ensure label claim potency

Overage is added to account for drug degradation during sterilization processes (e.g., autoclaving) so the final product meets its labeled potency.

Question 64: An 80-kg patient needs phenytoin 15 mg/kg in 250 mL of NS. Stock vial is 250 mg/5 mL. What volume should be withdrawn?

30 mL
18 mL
12 mL
24 mL (Correct answer)

Correct answer: 24 mL

Loading dose is 1,200 mg. Stock is 50 mg/mL. Volume is 1,200 divided by 50 equals 24 mL.

Question 65: What is the significance of the sterility assurance level (SAL)?

It is the percentage passing visual inspection
It measures shelf life
It represents the probability of a single viable microorganism surviving after sterilization, typically 10 to the negative 6 or better (Correct answer)
It indicates required storage temperature

Correct answer: It represents the probability of a single viable microorganism surviving after sterilization, typically 10 to the negative 6 or better

A SAL of 10 to the negative 6 means less than one in a million chance that a viable microorganism survives.

Question 66: What is the primary reason why multi-dose vials (MDVs) have a 28-day in-use BUD after initial puncture, according to USP <797>?

The preservative system becomes less effective over time after repeated punctures (Correct answer)
The rubber stopper degrades and leaches into the solution
Evaporation of the solvent concentrates the active ingredient
The drug undergoes photodegradation after the seal is broken

Correct answer: The preservative system becomes less effective over time after repeated punctures

Repeated needle punctures can introduce contaminants that overwhelm preservatives over time, so the 28-day limit reflects the window during which the antimicrobial preservative system remains reliably effective.

Question 67: What type of filter is recommended when administering a total parenteral nutrition solution that does NOT contain lipid emulsion?

5-micron filter
No filter required
1.2-micron filter
0.22-micron filter (Correct answer)

Correct answer: 0.22-micron filter

A 0.22-micron filter is used for lipid-free TPN to remove particulates and microorganisms during administration.

Question 68: Which macronutrient in total parenteral nutrition (TPN) is the PRIMARY energy source and contributes 3.4 kcal per gram?

Lipid emulsion
Amino acids
Electrolytes
Dextrose (Correct answer)

Correct answer: Dextrose

Dextrose (glucose) in parenteral nutrition provides 3.4 kcal/g and is the primary carbohydrate energy substrate.

Question 69: Which of the following items is NOT permitted to be brought directly into the ISO Class 5 critical zone of a laminar airflow workbench?

IPA-wiped ampules
Cardboard boxes or outer packaging of supply items (Correct answer)
Alcohol-disinfected vials
Sterile syringes in their inner packaging

Correct answer: Cardboard boxes or outer packaging of supply items

Cardboard and outer packaging harbor high levels of particles and microorganisms and must never enter the critical zone or buffer area; only the inner sterile packaging may be introduced.

Question 70: What type of waste container is required for disposing of hazardous drug-contaminated materials?

Yellow chemotherapy waste containers approved by EPA (Correct answer)
Sharps containers only
Regular trash containers if double-bagged
Standard biohazard red bags

Correct answer: Yellow chemotherapy waste containers approved by EPA

Hazardous drug waste must be placed in approved chemotherapy/HD waste containers that comply with EPA and state regulations.

Question 71: A technician notices that a vial of vancomycin powder for injection has turned slightly yellow. What is the appropriate action?

Return it to the shelf if within expiration date
Quarantine the vial and report to the pharmacist (Correct answer)
Mix it and check final solution color instead
Use it immediately before further discoloration occurs

Correct answer: Quarantine the vial and report to the pharmacist

Any visual change in an API or drug product is grounds for quarantine and pharmacist evaluation, as discoloration may indicate degradation.

Question 72: A prescription requires 40 mEq of potassium chloride (KCl). The pharmacy has a stock vial of KCl with a concentration of 2 mEq/mL. How many milliliters of this solution should the technician draw?

20 mL (Correct answer)
40 mL
80 mL
10 mL

Correct answer: 20 mL

This is a direct dosage calculation. To find the required volume, divide the total required mEq by the concentration of the solution. Volume = Total mEq / Concentration (mEq/mL). Volume = 40 mEq / 2 mEq/mL = 20 mL.

Question 73: What is the recommended order of addition when compounding a TPN admixture to minimize calcium-phosphate precipitation?

Calcium last, phosphate first (Correct answer)
Phosphate last, calcium first
Add both simultaneously
Order does not matter

Correct answer: Calcium last, phosphate first

Phosphate should be added first and diluted well before calcium is added last, minimizing localized precipitation risk.

Question 74: How long must compounding records be retained according to USP 797?

As dictated by state regulations and organizational policy (Correct answer)
1 year
3 years
6 months

Correct answer: As dictated by state regulations and organizational policy

USP 797 requires records be maintained but defers to state pharmacy regulations for specific retention periods.

Question 75: How many mEq of potassium are in 30 mL of potassium chloride 2 mEq/mL?

15 mEq
60 mEq (Correct answer)
2 mEq
30 mEq

Correct answer: 60 mEq

30 mL × 2 mEq/mL = 60 mEq.

CSPT Certified Compounded Sterile Preparation Technician Exam

The PTCB CSPT exam certifies pharmacy technicians in sterile compounding, covering medications, facilities, compounding procedures, and handling per USP <797> standards.

Questions

120 min

Time Limit

70%

To Pass

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These practice questions were written with AI tools. They are not real exam questions. Exam facts are checked against the official sources listed below. Not reviewed by a subject-matter expert. Editorial policy

Sources & references

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ptcb.org — Late registration, registration deadline, renewal, test delivery, eligibility, fees, exam format, passing score, score release, test dates · verified Oct 2026
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