Compounding sterile preparations (CSPs) is a critical area of pharmacy practice that requires meticulous attention to detail, extensive training, and a controlled environment to ensure patient safety. The primary goal is to prevent harm to patients from microbial contamination, excessive bacterial endotoxins, and other potential contaminants. Adherence to standards outlined in United States Pharmacopeia (USP) chapters, particularly USP <797>, is essential for any individual involved in sterile compounding. For PharmD students, a comprehensive understanding of these principles—from aseptic technique and garbing procedures to environmental controls and quality assurance—is fundamental for safe and effective practice. This MCQ quiz will test your knowledge on the key concepts of compounding sterile preparations.
1. The primary goal of sterile compounding according to USP <797> is to:
- A. Ensure the medication is cost-effective.
- B. Prevent patient harm resulting from microbial, chemical, or physical contamination.
- C. Increase the shelf-life of all medications.
- D. Make the compounding process faster.
Answer: B. Prevent patient harm resulting from microbial, chemical, or physical contamination.
2. A Primary Engineering Control (PEC) is a device that provides an ISO Class 5 environment for compounding CSPs. Which of the following is an example of a PEC?
- A. The ante-room
- B. A Laminar Airflow Workbench (LAFW) or Biological Safety Cabinet (BSC)
- C. The buffer room
- D. A refrigerator for storing CSPs
Answer: B. A Laminar Airflow Workbench (LAFW) or Biological Safety Cabinet (BSC)
3. An ISO Class 5 environment must have an air particle count of no more than:
- A. 3,520 particles of 0.5 micron size or larger per cubic meter of air.
- B. 35,200 particles of 0.5 micron size or larger per cubic meter of air.
- C. 352,000 particles of 0.5 micron size or larger per cubic meter of air.
- D. 100 particles of any size per cubic foot of air.
Answer: A. 3,520 particles of 0.5 micron size or larger per cubic meter of air. (This corresponds to 100 particles/ft³).
4. The buffer room, or cleanroom, where the PEC is located, must typically be maintained as which ISO Class?
- A. ISO Class 5
- B. ISO Class 6
- C. ISO Class 7
- D. ISO Class 8
Answer: C. ISO Class 7
5. The concept of “first air” in aseptic technique refers to:
- A. The air immediately exiting the HEPA filter that is essentially free of particles.
- B. The air outside of the cleanroom.
- C. The air that has been recirculated within the PEC.
- D. The air sample taken for environmental monitoring.
Answer: A. The air immediately exiting the HEPA filter that is essentially free of particles. (Critical sites must be constantly exposed to first air).
6. When garbing to enter a sterile compounding area, what is the generally accepted order for donning personal protective equipment (PPE)?
- A. Gloves first, then gown, then hair cover.
- B. From “dirtiest” to “cleanest”: Don shoe covers, head/facial hair covers, and face mask first, then perform hand hygiene, then don gown.
- C. Gown first, then gloves, then mask.
- D. The order does not matter as long as all items are worn.
Answer: B. From “dirtiest” to “cleanest”: Don shoe covers, head/facial hair covers, and face mask first, then perform hand hygiene, then don gown. (Gloves are donned last inside the buffer room).
7. In a horizontal laminar airflow workbench (LAFW), where is the HEPA filter located?
- A. At the top of the workbench, blowing air down.
- B. At the back of the workbench, blowing air towards the compounder.
- C. At the front of the workbench.
- D. Underneath the work surface.
Answer: B. At the back of the workbench, blowing air towards the compounder.
8. When compounding non-hazardous sterile preparations, manipulations should be performed at least how far inside the PEC?
- A. 1 inch from the front edge
- B. 3 inches from the sides and front edge
- C. 6 inches from the front, back, and sides of the workbench
- D. Anywhere on the work surface is acceptable.
Answer: C. 6 inches from the front, back, and sides of the workbench (Generally, 6 inches from the sides and front, and not blocking the back).
9. A “media-fill test” is used to:
- A. Calibrate the compounding equipment.
- B. Validate a compounder’s aseptic technique by simulating the compounding process with a microbial growth medium.
- C. Determine the beyond-use date of a CSP.
- D. Test the HEPA filter for leaks.
Answer: B. Validate a compounder’s aseptic technique by simulating the compounding process with a microbial growth medium.
10. According to the updated USP <797> guidelines, Compounded Sterile Preparations (CSPs) are classified into Categories 1, 2, and 3 based primarily on:
- A. The type of drug being compounded.
- B. The conditions under which they are made (e.g., environment, starting ingredients), which determines the potential for microbial contamination.
- C. The final volume of the CSP.
- D. The cost of the ingredients.
Answer: B. The conditions under which they are made (e.g., environment, starting ingredients), which determines the potential for microbial contamination.
11. The Beyond-Use Date (BUD) for a CSP is determined by:
- A. The manufacturer’s expiration date of the ingredients only.
- B. The time it takes to compound the preparation.
- C. Its potential for microbial contamination (based on its Category and storage temperature) and its chemical/physical stability, whichever is shorter.
- D. A standard of 30 days for all CSPs.
Answer: C. Its potential for microbial contamination (based on its Category and storage temperature) and its chemical/physical stability, whichever is shorter.
12. Which type of PEC is required for compounding hazardous sterile drugs to protect both the compounder and the preparation?
- A. A horizontal laminar airflow workbench (LAFW)
- B. A Compounding Aseptic Isolator (CAI) with positive pressure
- C. A Biological Safety Cabinet (BSC Class II) or a Compounding Aseptic Containment Isolator (CACI), which are externally vented
- D. Any clean bench in a segregated compounding area
Answer: C. A Biological Safety Cabinet (BSC Class II) or a Compounding Aseptic Containment Isolator (CACI), which are externally vented
13. A “gloved fingertip and thumb sampling” test is performed by personnel to:
- A. Check for dexterity.
- B. Assess the effectiveness of their hand hygiene and garbing technique.
- C. Determine the size of gloves needed.
- D. Calibrate the gloves for pressure sensitivity.
Answer: B. Assess the effectiveness of their hand hygiene and garbing technique.
14. What is the most common source of contamination for a CSP?
- A. The air from the HEPA filter
- B. The sterile drug vials
- C. Touch contamination from personnel
- D. The syringe and needle packaging
Answer: C. Touch contamination from personnel
15. Before being used to disinfect surfaces within the PEC, sterile 70% Isopropyl Alcohol (IPA) should be allowed to:
- A. Evaporate completely to ensure it is dry.
- B. Sit for at least 30 minutes.
- C. Be immediately wiped away with a dry gauze.
- D. Be diluted with sterile water to a 50% concentration.
Answer: A. Evaporate completely to ensure it is dry. (Dwell time is important for disinfectant action).
16. The process of removing bacterial endotoxins (pyrogens) from materials is called:
- A. Sterilization
- B. Disinfection
- C. Depyrogenation (e.g., using dry heat)
- D. Filtration
Answer: C. Depyrogenation (e.g., using dry heat)
17. When drawing fluid from a vial, it is necessary to first inject an equal volume of air into the vial (unless it’s a hazardous drug or specific product) to:
- A. Sterilize the vial contents.
- B. Prevent a vacuum from forming, making it easier to withdraw the liquid.
- C. Increase the concentration of the drug.
- D. Dilute the drug.
Answer: B. Prevent a vacuum from forming, making it easier to withdraw the liquid.
18. When opening a glass ampule, one must:
- A. Use a filter needle or filter straw to withdraw the contents to remove any potential glass shards.
- B. Heat the ampule neck before breaking.
- C. Break the ampule with bare hands.
- D. Use the same needle to withdraw from the ampule and inject into the final container.
Answer: A. Use a filter needle or filter straw to withdraw the contents to remove any potential glass shards. (A regular needle is then used for injection).
19. Which of the following is an example of a low-risk compounding procedure under the historical risk level system (now supplanted by Categories 1/2/3)?
- A. Reconstituting a single sterile vial of antibiotic and transferring it to a small-volume parenteral bag.
- B. Preparing a total parenteral nutrition (TPN) solution using an automated compounder.
- C. Compounding with non-sterile ingredients.
- D. Preparing a batch of syringes for multiple patients.
Answer: A. Reconstituting a single sterile vial of antibiotic and transferring it to a small-volume parenteral bag. (This aligns with the concept of a less complex, lower-risk manipulation).
20. According to USP <800> guidelines for handling hazardous drugs, the secondary engineering control (buffer room) containing a C-PEC must be:
- A. Under positive pressure relative to adjacent areas.
- B. Under negative pressure relative to adjacent areas to contain any hazardous contaminants.
- C. At neutral pressure.
- D. Open to the general pharmacy area.
Answer: B. Under negative pressure relative to adjacent areas to contain any hazardous contaminants.
21. A “sporicidal” agent is required for cleaning compounding areas because it is effective at killing:
- A. Only gram-positive bacteria
- B. Only viruses
- C. Fungal and bacterial spores
- D. Only gram-negative bacteria
Answer: C. Fungal and bacterial spores
22. The ante-room is the area adjacent to the buffer room. Its primary purpose is to:
- A. Be the main storage area for all drugs.
- B. Serve as a space for hand hygiene, garbing, and staging of components, acting as a transition area to the cleaner buffer room.
- C. House the Primary Engineering Control.
- D. Be a general office space for pharmacists.
Answer: B. Serve as a space for hand hygiene, garbing, and staging of components, acting as a transition area to the cleaner buffer room.
23. The most common method for sterilizing a heat-labile solution (e.g., a protein-based drug) is:
- A. Autoclaving (steam sterilization)
- B. Dry heat sterilization
- C. Filtration using a 0.22-micron filter
- D. Gas sterilization with ethylene oxide
Answer: C. Filtration using a 0.22-micron filter
24. The term “aseptic technique” refers to the set of practices and procedures used to:
- A. Calculate drug doses accurately.
- B. Maintain the sterility of objects and prevent contamination of CSPs.
- C. Clean the compounding environment effectively.
- D. Document compounding procedures.
Answer: B. Maintain the sterility of objects and prevent contamination of CSPs.
25. When working in a vertical laminar airflow workbench (VLAFW) or a BSC, where does the “first air” originate?
- A. From the back of the hood
- B. From the top of the hood
- C. From the sides of the hood
- D. From the front opening
Answer: B. From the top of the hood
26. What does “donning” and “doffing” refer to in the context of sterile compounding?
- A. Calibrating and cleaning equipment
- B. The processes of putting on and taking off personal protective equipment (PPE)
- C. Starting and stopping the PEC
- D. Labeling and checking CSPs
Answer: B. The processes of putting on and taking off personal protective equipment (PPE)
27. A “Master Formulation Record” for a CSP contains:
- A. The specific information about a single, specific batch that was compounded.
- B. The detailed “recipe” and instructions on how to prepare a specific CSP, which is followed every time that CSP is made.
- C. A log of all personnel who entered the cleanroom.
- D. The results of environmental monitoring.
Answer: B. The detailed “recipe” and instructions on how to prepare a specific CSP, which is followed every time that CSP is made.
28. A “Compounding Record” contains:
- A. The general recipe for a CSP.
- B. The specific documentation for a particular compounded preparation or batch, including lot numbers, quantities, and personnel involved.
- C. The pharmacy’s policies and procedures.
- D. A list of all available sterile drugs.
Answer: B. The specific documentation for a particular compounded preparation or batch, including lot numbers, quantities, and personnel involved.
29. What is the purpose of a HEPA (High-Efficiency Particulate Air) filter in a PEC?
- A. To heat the air to a sterilizing temperature.
- B. To remove at least 99.97% of airborne particles that are 0.3 microns in diameter or larger.
- C. To add moisture to the air.
- D. To remove chemical fumes from the air.
Answer: B. To remove at least 99.97% of airborne particles that are 0.3 microns in diameter or larger.
30. Which of the following items should NEVER be brought into the cleanroom (buffer room)?
- A. Sterile syringes and needles in their packaging
- B. Vials of sterile drugs that have been wiped down
- C. Cardboard boxes, paper towels, and personal items like makeup or jewelry
- D. Carts made of stainless steel
Answer: C. Cardboard boxes, paper towels, and personal items like makeup or jewelry (as they are high-particulate-shedding items).
31. The “zone of turbulence” in a horizontal LAFW is located:
- A. At the back of the hood near the filter.
- B. Directly in front of large objects placed in the hood, where airflow is disrupted.
- C. Along the sides of the hood.
- D. There is no turbulence in a LAFW.
Correction: The primary zone of turbulence is downstream from objects, which in a horizontal flow hood is between the object and the operator. 31. The “zone of turbulence” created by an object in a horizontal LAFW is located:
- A. Only at the back of the hood.
- B. On top of the object.
- C. Downstream of the object (i.e., between the object and the compounder).
- D. Upstream of the object (i.e., between the object and the HEPA filter).
Answer: C. Downstream of the object (i.e., between the object and the compounder).
32. The needle of a syringe should never be touched or laid down on a non-sterile surface. The critical sites of a syringe and needle are the:
- A. Barrel and the plunger handle
- B. Syringe tip (Luer-Lok) and the entire needle (hub, shaft, and bevel)
- C. Only the barrel and the needle cap
- D. Only the measurement markings on the barrel
Answer: B. Syringe tip (Luer-Lok) and the entire needle (hub, shaft, and bevel)
33. What is the purpose of wiping vial stoppers, ampule necks, and injection ports with sterile 70% IPA before use?
- A. To make them easier to see.
- B. To disinfect the surface and remove particulate matter.
- C. To warm the container.
- D. To increase the pressure inside the vial.
Answer: B. To disinfect the surface and remove particulate matter.
34. The term “aseptic” means:
- A. Free of all living microorganisms and their spores (sterile).
- B. Free from disease-causing microorganisms.
- C. The techniques and procedures used to prevent microbial contamination.
- D. A substance that inhibits the growth of bacteria.
Answer: C. The techniques and procedures used to prevent microbial contamination. (While the goal is sterility, aseptic technique itself is the process of preventing contamination).
35. A “single-dose vial” (SDV) with no antimicrobial preservatives should ideally be used:
- A. For up to 28 days after opening if stored in the refrigerator.
- B. For multiple patients as long as aseptic technique is used.
- C. For a single patient for a single procedure, and discarded after opening. If opened in an ISO Class 5 environment, it can be used for up to 12 hours.
- D. Only for oral medications.
Answer: C. For a single patient for a single procedure, and discarded after opening. If opened in an ISO Class 5 environment, it can be used for up to 12 hours. (Referencing updated USP guidelines).
36. A “multi-dose vial” (MDV) contains antimicrobial preservatives and can be used for multiple needle entries. What is its typical beyond-use date after the first puncture?
- A. 12 hours
- B. 7 days
- C. 28 days, unless otherwise specified by the manufacturer
- D. 90 days
Answer: C. 28 days, unless otherwise specified by the manufacturer
37. Environmental monitoring in a sterile compounding facility includes:
- A. Only checking the temperature of the refrigerator.
- B. Air sampling, surface sampling, and personnel testing (gloved fingertip sampling).
- C. Reviewing compounding records.
- D. Calibrating the LAFW once per year.
Answer: B. Air sampling, surface sampling, and personnel testing (gloved fingertip sampling).
38. The air pressure relationship between the buffer room and the ante-room for non-hazardous compounding should be:
- A. The buffer room should be at a negative pressure to the ante-room.
- B. The buffer room should be at a positive pressure to the ante-room.
- C. Both rooms should be at neutral pressure.
- D. The pressure does not matter.
Answer: B. The buffer room should be at a positive pressure to the ante-room. (To ensure air flows from cleaner to less clean areas).
39. When reconstituting a powder vial, a common issue is positive pressure buildup. To prevent this, one can use:
- A. A smaller needle.
- B. A venting needle or the technique of adding diluent and withdrawing air in small increments.
- C. A larger syringe.
- D. A filter straw.
Answer: B. A venting needle or the technique of adding diluent and withdrawing air in small increments.
40. What is the purpose of performing a “bubble point test”?
- A. To test the integrity of a sterilizing filter after use.
- B. To check for leaks in an IV bag.
- C. To measure the concentration of a drug.
- D. To test the compounder’s ability to draw up liquid without bubbles.
Answer: A. To test the integrity of a sterilizing filter after use.
41. USP Chapter <800> provides standards specifically for:
- A. Non-sterile compounding.
- B. Handling hazardous drugs to protect personnel, patients, and the environment.
- C. Radiopharmaceuticals.
- D. Environmental monitoring.
Answer: B. Handling hazardous drugs to protect personnel, patients, and the environment.
42. A pharmacist needs to prepare an IV bag containing 500 mg of a drug. The drug is available as a 100 mg/mL solution in a vial. How many mL should be withdrawn from the vial?
- A. 0.5 mL
- B. 2.0 mL
- C. 5.0 mL
- D. 10.0 mL
Answer: C. 5.0 mL (500 mg / 100 mg/mL = 5 mL).
43. Personal Protective Equipment (PPE) for compounding sterile hazardous drugs generally includes:
- A. A single pair of regular exam gloves.
- B. Two pairs of chemotherapy-rated gloves, a non-shedding gown, head/hair/shoe covers, and often eye protection and a respirator.
- C. A cloth lab coat and a face mask.
- D. Goggles only.
Answer: B. Two pairs of chemotherapy-rated gloves, a non-shedding gown, head/hair/shoe covers, and often eye protection and a respirator.
44. The line of demarcation in an ante-room separates:
- A. Hazardous and non-hazardous drugs.
- B. The clean side from the dirty side.
- C. Refrigerated items from room temperature items.
- D. The pharmacist’s area from the technician’s area.
Answer: B. The clean side from the dirty side.
45. Which of the following is a critical site that should not be blocked from first air during sterile compounding?
- A. The syringe barrel
- B. The vial stopper after it has been swabbed, the syringe tip, and the needle hub/shaft
- C. The outside of the IV bag
- D. The alcohol prep pad wrapper
Answer: B. The vial stopper after it has been swabbed, the syringe tip, and the needle hub/shaft
46. “Coring” is a problem that can occur when inserting a needle into a vial stopper. It refers to:
- A. The vial stopper cracking.
- B. A piece of the rubber stopper being sheared off and falling into the vial.
- C. The needle becoming bent.
- D. The drug precipitating out of solution.
Answer: B. A piece of the rubber stopper being sheared off and falling into the vial. (Can be prevented by inserting the needle with the bevel up at a 45-60 degree angle).
47. The term “pyrogen” refers to a substance, typically from bacteria (like endotoxins), that can cause:
- A. Allergic reactions
- B. Fever
- C. Vasodilation
- D. Sedation
Answer: B. Fever
48. Why is it important to swab surfaces in the PEC with sterile 70% isopropyl alcohol and allow it to dry?
- A. The swabbing action provides all the necessary cleaning.
- B. The drying/evaporation process (dwell time) is essential for the alcohol’s disinfectant properties to work.
- C. It makes the surfaces shiny.
- D. It is not important to let it dry.
Answer: B. The drying/evaporation process (dwell time) is essential for the alcohol’s disinfectant properties to work.
49. An immediate-use CSP is one that is compounded:
- A. In an ISO Class 5 PEC located in an ISO Class 7 buffer room.
- B. From non-sterile ingredients.
- C. In emergency situations outside of a controlled environment, for administration within 4 hours (per new guidelines).
- D. For a batch of 50 patients.
Answer: C. In emergency situations outside of a controlled environment, for administration within 4 hours (per new guidelines).
50. The ultimate responsibility for ensuring the safety and accuracy of a compounded sterile preparation lies with the:
- A. Patient receiving the CSP.
- B. Pharmacy technician who compounded it.
- C. Pharmacist who performs the final verification.
- D. Wholesaler who supplied the drugs.
Answer: C. Pharmacist who performs the final verification.