CSCP Practice Test

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CSCP Practice Test (V1)

Dive into practice questions

Question 1

According to USP Chapter <797>, what is the minimum air quality required for a primary engineering control (PEC) such as a laminar airflow workbench (LAFW)?

  1. ISO Class 8
  2. ISO Class 7
  3. ISO Class 5
  4. ISO Class 3

Question 2

When performing aseptic manipulations, all materials must be wiped with sterile 70% isopropyl alcohol (IPA) before being introduced into the direct compounding area (DCA). What is the primary reason for this step?

  1. To sterilize the surface of the materials completely.
  2. To remove particulate matter and reduce the bioburden on the items.
  3. To cool the materials before they enter the controlled environment.
  4. To ensure the materials have a pleasant smell.

Question 3

A pharmacist is preparing a batch of high-risk level compounded sterile products (CSPs). What is a defining characteristic of a high-risk level CSP?

  1. The compounding involves only the transfer of sterile commercial drugs using sterile needles and syringes.
  2. The final product will be administered to more than three patients.
  3. The compounding process uses non-sterile ingredients or a non-sterile device at some point before terminal sterilization.
  4. The beyond-use date (BUD) is less than 12 hours.

Question 4

What is the correct order for donning Personal Protective Equipment (PPE) before entering a sterile compounding cleanroom suite?

  1. Gloves, gown, hair cover, face mask, shoe covers.
  2. Shoe covers, hair cover, face mask, gown, gloves.
  3. Hair cover, face mask, shoe covers, gloves, gown.
  4. Gown, gloves, shoe covers, hair cover, face mask.

Answer Key

  • Question 1: C. ISO Class 5. (USP <797> mandates that the air within the PEC, where critical manipulations occur, must meet or exceed ISO Class 5 standards, which allows for no more than 3,520 particles per cubic meter of air.)
  • Question 2: B. To remove particulate matter and reduce the bioburden on the items. (While sterile IPA is a disinfectant, its primary role in this context is to clean the surfaces of items, removing particles and microorganisms before they can contaminate the sterile field. It does not guarantee sterilization.)
  • Question 3: C. The compounding process uses non-sterile ingredients or a non-sterile device at some point before terminal sterilization. (This is the definition of high-risk compounding. It introduces a significant risk of microbial contamination that must be eliminated by a subsequent sterilization step, such as filtration or autoclaving.)
  • Question 4: B. Shoe covers, hair cover, face mask, gown, gloves. (PPE should generally be donned from “dirtiest” to “cleanest.” Shoe covers are first, followed by head/face protection. The gown is put on before entering the buffer area, and sterile gloves are donned last, just before compounding begins.)