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BCSCP practice questions

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Question 1Sterile Compounding Process and Technique

Which action is performed first when a compounder enters the ante area to begin garbing?

  1. Put on sterile gloves before hand hygiene
  2. Clean shoe soles with a sporicidal agent first
  3. Don a hair cover and beard cover before hand hygiene
  4. Cleanse hands with soap and water or alcohol rub Correct answer.

Explanation

Hand hygiene is the first step in the garbing sequence and is performed before any garb is donned. Garb items are then applied in a defined order, with sterile gloves applied last.

Question 2Sterile Compounding Process and Technique

Which garb item is donned last before entering the buffer area?

  1. Face mask
  2. Hair cover
  3. Sterile gloves Correct answer.
  4. Shoe covers

Explanation

Sterile gloves are applied after all other garb so that they remain sterile and do not contact nonsterile outer garments. The rest of the garb is applied in sequence before gloving.

Question 3Sterile Compounding Process and Technique

The direct compounding area where sterile ingredients and critical sites are exposed must meet which ISO classification?

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

Explanation

The primary engineering control provides an ISO Class 5 environment at the direct compounding area. The surrounding buffer area is typically ISO Class 7.

Question 4Sterile Compounding Process and Technique

A HEPA filter used in sterile compounding primary engineering controls must remove at least what percentage of particles 0.3 micrometers or larger?

  1. 95.0%
  2. 99.97% Correct answer.
  3. 99.0%
  4. 99.999%

Explanation

HEPA filters are rated to remove at least 99.97% of airborne particles 0.3 micrometers or larger. This efficiency is fundamental to producing ISO Class 5 air.

Question 5Sterile Compounding Process and Technique

Which primary engineering control supplies unidirectional horizontal airflow across the work surface?

  1. Horizontal laminar airflow workbench Correct answer.
  2. Compounding aseptic containment isolator
  3. Biological safety cabinet
  4. Compounding aseptic isolator

Explanation

A horizontal laminar airflow workbench delivers HEPA-filtered air horizontally across the work surface. Biological safety cabinets and isolators use different airflow designs.

Question 6Sterile Compounding Process and Technique

Which item is considered a critical site during sterile compounding?

  1. The exterior of a glove
  2. The sterile tip of a syringe Correct answer.
  3. The edge of the workbench
  4. The outside surface of a vial cap

Explanation

A critical site is any surface that can contact the sterile product or sterile components and must remain sterile. The syringe tip is a critical site because it directly contacts the CSP.

Question 7Sterile Compounding Process and Technique

In a horizontal laminar airflow workbench, first air is best described as:

  1. Air returning through the prefilter
  2. Air that has crossed the operator's gown
  3. Air leaving the exhaust grille
  4. Air straight from the HEPA filter Correct answer.

Explanation

First air is HEPA-filtered air that has not yet passed over any object or person. Critical sites should be positioned in first air to avoid contamination.

Question 8Sterile Compounding Process and Technique

Which technique is appropriate when withdrawing medication from a glass ampule?

  1. Break the ampule toward the body and withdraw without filtering
  2. Insert a regular needle directly into the bottom of the ampule
  3. Use a filter needle or filter straw to withdraw the contents Correct answer.
  4. Shake the ampule vigorously before withdrawing

Explanation

Glass ampules can shed glass particles when opened, so a filter needle or filter straw is used to withdraw the contents. The ampule should be handled carefully and not shaken.

Question 9Sterile Compounding Process and Technique

How should a needle be inserted into a vial stopper to minimize coring?

  1. Through the center of the stopper with a large-bore needle
  2. With the needle bent to 30 degrees before insertion
  3. Bevel up at 45 degrees, then rotate to 90 degrees Correct answer.
  4. With the bevel down at 90 degrees in one motion

Explanation

Inserting with the bevel up at a 45-degree angle and then rotating the needle to 90 degrees reduces the chance of cutting a rubber core from the stopper. Large-bore needles and forceful straight insertion increase coring risk.

Question 10Sterile Compounding Process and Technique

What pressure relationship is required between the buffer area and the adjacent ante area?

  1. Positive pressure in buffer relative to ante Correct answer.
  2. Alternating pressure every hour
  3. Negative pressure in buffer relative to ante
  4. Equal pressure in both areas

Explanation

The buffer area is kept at a positive pressure relative to the ante area to help prevent ingress of less clean air. This pressure differential supports the cleanliness of the buffer area.

Question 11Sterile Compounding Process and Technique

Which agent is appropriate for disinfecting the work surface of an ISO Class 5 primary engineering control before compounding?

  1. Sterile water for irrigation
  2. Sterile 70% IPA Correct answer.
  3. Sodium hypochlorite 5.25%
  4. Tap water with detergent

Explanation

Sterile 70% isopropyl alcohol is a standard disinfectant for ISO Class 5 work surfaces because it is effective and leaves minimal residue. It should be applied after cleaning and allowed to dry.

Question 12Sterile Compounding Process and Technique

Viable air sampling in the buffer area is performed primarily to:

  1. Detect microorganisms in the air Correct answer.
  2. Verify HEPA filter efficiency
  3. Measure nonviable particle counts
  4. Check airflow velocity

Explanation

Viable air sampling captures airborne microorganisms and assesses the microbiological quality of the environment. Nonviable particle counts and airflow velocity measurements evaluate different parameters.

Question 13Sterile Compounding Process and Technique

Gloved fingertip sampling is used to evaluate which of the following?

  1. Calibration accuracy of the balance
  2. Integrity of the HEPA filter
  3. Hand hygiene and glove disinfection technique Correct answer.
  4. Sterility assurance of the final compounded product

Explanation

Gloved fingertip sampling detects microbial contamination on gloved hands and reflects hand hygiene and glove disinfection technique. It is a personnel monitoring tool, not a product sterility test.

Question 14Sterile Compounding Process and Technique

Which method is used to sample viable contamination on a work surface?

  1. Differential pressure monitoring
  2. Contact plate sampling Correct answer.
  3. Airflow visualization with smoke
  4. Laser particle counting

Explanation

Contact plates, sometimes called RODAC plates, are pressed against a surface to recover viable microorganisms. Particle counters, smoke studies, and pressure gauges measure nonviable or physical parameters.

Question 15Sterile Compounding Process and Technique

Which primary engineering control is appropriate for preparing a hazardous drug CSP?

  1. Non-vented compounding aseptic isolator
  2. Horizontal laminar airflow workbench
  3. Class II biological safety cabinet Correct answer.
  4. Open-front horizontal clean bench

Explanation

A Class II biological safety cabinet provides both an ISO Class 5 work area and containment of hazardous drug aerosols. Open horizontal benches would blow hazardous particles toward the operator.

Question 16Sterile Compounding Process and Technique

A compounding aseptic isolator differs from an open-front laminar airflow workbench mainly because it:

  1. Cannot be used for nonhazardous CSPs
  2. Does not require HEPA filtration
  3. Operates without any environmental monitoring
  4. Is a closed system with attached gloves Correct answer.

Explanation

A compounding aseptic isolator is a closed enclosure with attached gloves that separates the compounding environment from the operator. It still uses HEPA filtration and requires environmental monitoring.

Question 17Sterile Compounding Process and Technique

What is the purpose of a pass-through chamber on an aseptic isolator?

  1. To sterilize supplies with ultraviolet light only
  2. To monitor air velocity
  3. To provide a workspace for hazardous drugs
  4. To pass supplies in without opening the chamber Correct answer.

Explanation

A pass-through allows supplies to enter the isolator while minimizing opening of the main chamber and exposure to the surrounding environment. It is not a substitute for sterilization or monitoring.

Question 18Sterile Compounding Process and Technique

Before inserting a needle into a vial stopper, the stopper should be:

  1. Covered with a fresh sterile cap after flaming
  2. Rinsed with sterile water
  3. Swabbed with 70% IPA and allowed to dry Correct answer.
  4. Flamed with an alcohol lamp

Explanation

The vial stopper is disinfected by swabbing with 70% isopropyl alcohol and allowing it to dry before needle entry. Allowing the alcohol to dry enhances its antimicrobial effect.

Question 19Sterile Compounding Process and Technique

Which needle has the largest internal diameter?

  1. 18 gauge Correct answer.
  2. 20 gauge
  3. 22 gauge
  4. 25 gauge

Explanation

Needle gauge is inversely related to diameter: a lower gauge number indicates a larger needle. An 18-gauge needle therefore has the largest internal diameter of the choices.

Question 20Sterile Compounding Process and Technique

Which filter pore size is used to sterilize a solution by filtration?

  1. 0.45 micrometers
  2. 0.22 micrometers Correct answer.
  3. 1.2 micrometers
  4. 5.0 micrometers

Explanation

A 0.22-micrometer filter is used for sterilizing filtration because it removes bacteria from solution. Larger pore sizes do not provide sterilization.

Question 21Sterile Compounding Process and Technique

After use, a contaminated needle should be:

  1. Clipped and discarded in a biohazard bag
  2. Recapped using two hands
  3. Placed in a sharps container Correct answer.
  4. Left on the work surface

Explanation

Used needles are disposed of directly in a puncture-resistant sharps container to prevent needlestick injury. Recapping, clipping, or leaving needles exposed increases injury risk.

Question 22Sterile Compounding Process and Technique

To minimize contamination in the buffer area, compounding personnel should:

  1. Move rapidly to reduce exposure time
  2. Stack items on the work surface near the critical site
  3. Avoid unnecessary movement and keep airflow undisturbed Correct answer.
  4. Place supplies directly in front of the HEPA filter

Explanation

Unnecessary movement disrupts unidirectional airflow and can draw contamination into critical sites. Compounders should work calmly and keep supplies arranged so first air reaches the critical site.

Question 23Sterile Compounding Process and Technique

Which set of conditions represents a standard steam sterilization cycle?

  1. 180 degrees C at atmospheric pressure for 5 minutes
  2. 250 degrees C for 30 minutes
  3. 121 degrees C at 15 psi for 15-30 minutes Correct answer.
  4. 100 degrees C at 5 psi for 60 minutes

Explanation

A standard autoclave cycle uses saturated steam at about 121 degrees C and 15 psi for 15 to 30 minutes, depending on the load. Higher temperatures may be used in specific validated cycles.

Question 24Sterile Compounding Process and Technique

Dry heat depyrogenation of glassware typically requires which condition?

  1. 134 degrees C for 4 minutes in a vacuum cycle
  2. 250 degrees C for at least 30 minutes Correct answer.
  3. 70 degrees C for 2 hours with forced air
  4. 121 degrees C for 15 minutes at 15 psi

Explanation

Dry heat depyrogenation destroys bacterial endotoxins at high temperature, commonly 250 degrees C for at least 30 minutes or an equivalent validated cycle. Lower temperatures do not reliably inactivate endotoxin.

Question 25Sterile Compounding Process and Technique

A media fill (simulated compounding) is performed to:

  1. Test the HEPA filter for leaks
  2. Measure the potency of an antibiotic
  3. Determine the maximum beyond-use date of a CSP
  4. Validate aseptic technique produces sterile CSPs Correct answer.

Explanation

A media fill uses sterile growth medium in place of drug to simulate compounding and detect contamination from technique or environment. Growth in the medium indicates a breach in aseptic technique.

Question 26Sterile Compounding Process and Technique

When opening a glass ampule for use in compounding, which technique is correct?

  1. Wrap the neck in a gauze pad and snap it away from the body Correct answer.
  2. Snap the neck toward the body while holding it bare-handed
  3. Twist the top off slowly while pointing it at the HEPA filter
  4. Score the neck with a file and break it against the hood's back wall

Explanation

A gauze pad protects the fingers and captures glass fragments, and the neck should be broken away from the compounder and away from the sterile field. Directing the break toward the body risks injury and contamination of the work area.

Question 27Sterile Compounding Process and Technique

During an active compounding session, how often should the work surface of the ISO Class 5 primary engineering control be cleaned and disinfected?

  1. Every 30 minutes Correct answer.
  2. Only after a documented contamination event
  3. Every 2 hours
  4. Only at the start and end of each shift

Explanation

USP standards require the direct compounding area to be cleaned and disinfected at the start of each shift, before each batch, after each spill, and at intervals not exceeding 30 minutes during active compounding. Frequent disinfection limits accumulation of organisms and particles at the critical site.

Question 28Sterile Compounding Process and Technique

The buffer area in which a primary engineering control is located must meet which ISO classification during compounding?

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

Explanation

The buffer area must meet ISO Class 7 at rest and in operation, and the primary engineering control within it must meet ISO Class 5. The buffer area reduces the particle burden presented to the PEC's HEPA filter.

Question 29Sterile Compounding Process and Technique

A sharps container in the compounding area should be replaced when it is:

  1. Half full
  2. Three-quarters full Correct answer.
  3. Past its labeled expiration date only
  4. Completely full

Explanation

Sharps containers are replaced before they are overfilled, typically when they reach about three-quarters capacity, so that no one is exposed to protruding needles. Overfilling creates a needlestick hazard during disposal.

Question 30Sterile Compounding Process and Technique

Certification of the HEPA filters in the primary engineering control and buffer area must be performed at least every:

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

Explanation

HEPA filters in sterile compounding facilities must be recertified at least every six months and after any repair, relocation, or filter replacement. Certification verifies filter integrity and airflow performance.

Question 31Sterile Compounding Process and Technique

Which type of wipe is appropriate for cleaning and disinfecting surfaces in the buffer area?

  1. Cotton gauze sponges
  2. Paper towels torn from a roll
  3. Reusable cloths laundered on site
  4. Low-lint, non-shedding wipes Correct answer.

Explanation

Surfaces in the buffer area must be wiped with low-lint, non-shedding wipes so the act of cleaning does not add particles or fibers to the environment. Gauze, paper towels, and reusable cloths shed and are not acceptable.

Question 32Sterile Compounding Process and Technique

Refrigerated CSPs must be stored within which temperature range?

  1. 2 to 8 °C Correct answer.
  2. -20 to -10 °C
  3. 8 to 15 °C
  4. 0 to 4 °C

Explanation

Refrigerated CSPs are stored at 2 to 8 °C, which slows degradation without freezing the preparation. Freezing can disrupt emulsions and precipitate drug, while warmer storage shortens the beyond-use date.

Question 33Sterile Compounding Process and Technique

Immediately before entering the buffer area from the ante area, gloved hands should be:

  1. Sprayed with disinfectant and kept wet
  2. Sanitized with 70% isopropyl alcohol and allowed to dry Correct answer.
  3. Wiped dry with a low-lint wipe
  4. Rinsed with sterile water for injection

Explanation

Gloved hands are sanitized with 70% isopropyl alcohol just before entering the buffer area and allowed to dry so the alcohol can act on the glove surface. Entering with wet gloves can carry residual alcohol into the critical area or reduce its contact time.

Question 34Sterile Compounding Process and Technique

A work surface is visibly soiled with dried residue. Which sequence is correct before compounding begins?

  1. Disinfect the surface first, then clean with a detergent wipe
  2. Disinfect the surface twice with the same wipe
  3. Rinse the surface with sterile water only
  4. Clean with a detergent wipe, then disinfect the surface Correct answer.

Explanation

Cleaning removes organic soil and residue, which allows the disinfectant to contact and kill organisms on the surface. Applying a disinfectant to soiled surfaces inactivates it and leaves contamination behind.

Question 35Sterile Compounding Process and Technique

When withdrawing 10 mL of solution from a sealed vial, what should be done before withdrawing?

  1. Withdraw the solution without adding air to avoid aerosols
  2. Inject air until the stopper begins to bulge
  3. Inject air equal to the volume to be withdrawn Correct answer.
  4. Pull back on the plunger to create negative pressure in the vial

Explanation

Injecting an amount of air equal to the volume to be removed equalizes pressure so the solution is easy to withdraw and the needle is not forced out. Over- or under-pressurizing the vial risks spray, foaming, or leakage.

Question 36Sterile Compounding Process and Technique

A medication is withdrawn from a glass ampule using a filter needle. Before administration, the compounder must:

  1. Replace the filter needle with a regular needle Correct answer.
  2. Withdraw the needle through the ampule neck a second time
  3. Rinse the filter needle with sterile water before use
  4. Keep the filter needle attached so the dose is filtered again

Explanation

The filter needle traps glass fragments during withdrawal, but a filter needle should not be used for injection because it delivers a smaller or altered dose. It is replaced with a regular needle before the dose leaves the syringe.

Question 37Sterile Compounding Process and Technique

In a total nutrient admixture containing dextrose, amino acids, electrolytes, and lipids, which component is added last?

  1. Phosphate
  2. Lipid emulsion Correct answer.
  3. Amino acids
  4. Dextrose

Explanation

The lipid emulsion is added last so the admixture can be visually inspected for precipitate or incompatibility before it becomes opaque. Mixing in this order also protects the emulsion from destabilization.

Question 38Sterile Compounding Process and Technique

Which device is required when compounding a hazardous drug CSP to prevent escape of drug vapor and aerosols?

  1. Needleless connector alone
  2. Vented needle with a hydrophobic filter
  3. Filter straw
  4. Closed system transfer device Correct answer.

Explanation

A closed system transfer device mechanically prevents transfer of hazardous drug vapor and aerosols between the vial, syringe, and administration set. Vented needles and simple connectors do not provide this containment.

Question 39Sterile Compounding Process and Technique

Which condition excludes a compounder from working in the buffer area?

  1. Wearing prescription eyeglasses
  2. An open lesion on the hand Correct answer.
  3. Wearing a beard cover over facial hair
  4. Having received an influenza vaccine last week

Explanation

Open lesions, sores, and rashes on the hands or wrists shed organisms and cannot be reliably covered, so affected personnel are excluded from compounding. Eyeglasses, vaccination, and a properly worn beard cover are acceptable.

Question 40Sterile Compounding Process and Technique

When reconstituting a lyophilized powder, the diluent should be:

  1. Injected directly onto the center of the stopper
  2. Injected rapidly onto the powder to break up clumps
  3. Directed down the inside wall of the vial Correct answer.
  4. Added before the vial closure is disinfected

Explanation

Directing the diluent down the inside wall reduces foaming and aerosol formation, which is especially important for proteins and hazardous drugs. The closure must be disinfected before any needle entry.

Question 41Sterile Compounding Process and Technique

Several syringes of the same drug are prepared during one compounding session. Which action is required?

  1. Label one syringe as a representative sample for the batch
  2. Label each syringe immediately after preparation Correct answer.
  3. Label only the outer bag at the end of the session
  4. Label the syringes when the shift ends

Explanation

Each syringe is a separate CSP and must be labeled as it is prepared with the drug, strength, quantity, and beyond-use date. Labeling later or by proxy invites mix-ups between identical-looking syringes.

Question 42Sterile Compounding Process and Technique

How should the accuracy of an electronic balance used for compounding be verified?

  1. With certified test weights before each use Correct answer.
  2. By weighing the same container twice and comparing results
  3. By comparing its readings against a graduated cylinder
  4. Annually by the manufacturer only

Explanation

A balance is checked with certified test weights at the start of each weighing session, and the check is documented. Weighing the same item twice tests repeatability, not accuracy against a known standard.

Question 43Sterile Compounding Process and Technique

A powdered drug for injection must be reconstituted. Which diluent should be used?

  1. The diluent specified by the manufacturer Correct answer.
  2. Bacteriostatic water for every CSP
  3. Sterile water for injection in every case
  4. 0.9% sodium chloride in every case

Explanation

The manufacturer's labeling specifies the diluent and volume that dissolve the drug and preserve its stability; substituting a different diluent can cause precipitation or inactivation. Bacteriostatic water is also unsuitable for many products and patient populations.

Question 44Sterile Compounding Process and Technique

In which order should a large work surface be cleaned?

  1. From the dirtiest area toward the cleanest area, using one wipe
  2. From the cleanest area outward, reusing each wipe until it dries
  3. Top to bottom, clean to dirty, using a new wipe for each pass Correct answer.
  4. Randomly, using a single wipe throughout the surface

Explanation

Surfaces are cleaned from top to bottom and from clean to dirty, with a new low-lint wipe for each direction or section. This prevents soil from being carried back onto already-cleaned areas.

Question 45Sterile Compounding Process and Technique

A CSP is prepared by dissolving a nonsterile bulk drug substance in sterile water and then sterilizing the solution by filtration. Which risk level applies?

  1. Medium risk
  2. Immediate use
  3. High risk Correct answer.
  4. Low risk

Explanation

Exposing a nonsterile ingredient or component to the sterile compounding process creates the highest risk of introducing microorganisms. High-risk CSPs also require terminal sterilization or filtration and additional environmental monitoring.

Question 46Sterile Compounding Process and Technique

Which test is performed to verify the integrity of a sterilizing filter before and after use?

  1. Gram stain
  2. Particle count of the filtered solution
  3. Limulus amebocyte lysate test
  4. Bubble point test Correct answer.

Explanation

The bubble point test measures the pressure needed to force air through a wetted filter; a value at or above the manufacturer's specification confirms the pores are intact. It is documented before and after filtration of the CSP.

Question 47Sterile Compounding Process and Technique

A PN solution containing calcium gluconate and potassium phosphate develops a white precipitate several hours after compounding. What is the most likely cause?

  1. Oxidation of the lipid emulsion
  2. Calcium-phosphate incompatibility Correct answer.
  3. Hydrolysis of the amino acids in the admixture
  4. Incomplete mixing of the dextrose

Explanation

Divalent calcium and phosphate can form insoluble calcium phosphate, and the precipitate may appear late as pH, temperature, or concentration shifts. The risk depends on the order of mixing, dilution, and the salt forms used.

Question 48Sterile Compounding Process and Technique

A compounder notices a tear in the HEPA filter of the primary engineering control. What is the correct action?

  1. Stop compounding, replace the filter, and recertify the unit Correct answer.
  2. Seal the tear with approved tape and document the repair
  3. Continue compounding but move the work area farther from the filter
  4. Increase the room air exchange rate and continue compounding

Explanation

A damaged HEPA filter cannot deliver ISO Class 5 first air, so compounding must stop until the filter is replaced and the unit is certified. Tape or changes in workflow do not restore filter integrity.

Question 49Sterile Compounding Process and Technique

Which syringe should be selected to measure 0.2 mL of a drug accurately?

  1. A 1 mL syringe Correct answer.
  2. A 10 mL syringe
  3. A 20 mL syringe
  4. A 60 mL syringe

Explanation

Measurement accuracy depends on the graduations of the syringe; a 1 mL syringe has fine enough markings to deliver 0.2 mL precisely. Large syringes have widely spaced graduations, so small volumes cannot be measured reliably.

Question 50Sterile Compounding Process and Technique

A compounder leaves the buffer area to retrieve an item and returns. Which action is required before resuming compounding?

  1. Change the outer gown only and resume compounding
  2. Rinse the gloves with sterile water before entry
  3. Wipe down the door handle with a disinfectant wipe and continue compounding
  4. Discard gloves, then re-garb and re-sanitize on return Correct answer.

Explanation

Gloves that have contacted surfaces outside the buffer area are considered contaminated, so they are removed on exit and the compounder re-gowns and re-sanitizes gloved hands before re-entering. This prevents tracking contamination back to the critical site.