CSPT - Compounded Sterile Preparation Technician Medication and Component Handling Questions and Answers 1 — Questions and Answers
Question 1: A technician is unpacking a shipment of sterile components, including vials of a hazardous drug. According to USP <800>, where should the initial unpacking of this shipment occur?
- In a pass-through chamber from a negative pressure area.
- Inside a certified biological safety cabinet (BSC).
- In an area that is neutral or under negative pressure. (Correct answer)
- Directly within the positive pressure non-hazardous buffer room.
Correct answer: In an area that is neutral or under negative pressure.
USP General Chapter <800> specifies that hazardous drugs (HDs) must be unpacked in an area that is either neutral or under negative pressure to contain any potential contamination from shipping containers. This prevents the spread of hazardous material into non-hazardous areas of the pharmacy. Unpacking directly in a positive pressure room or a PEC is incorrect and unsafe.
Question 2: When preparing to withdraw liquid from a vial, a technician notices a small piece of the rubber stopper has fallen into the solution. This phenomenon is known as:
- Precipitation
- Coring (Correct answer)
- Fragmentation
- Incompatibility
Correct answer: Coring
Coring is the shearing of a piece of the rubber stopper from a vial, which then falls into the medication solution. It is typically caused by improper needle insertion technique. Precipitation is the formation of a solid from a solution, fragmentation is the abrasion of small particles (not a whole piece), and incompatibility refers to a chemical reaction between mixed substances.
Question 3: A technician needs to disinfect the rubber stopper of a vial before piercing it with a needle inside the Primary Engineering Control (PEC). According to USP <797>, which of the following is the most appropriate agent to use?
- Sterile 40% isopropyl alcohol
- Non-sterile 70% isopropyl alcohol
- Sterile 70% isopropyl alcohol (Correct answer)
- Sterile water for irrigation
Correct answer: Sterile 70% isopropyl alcohol
USP <797> requires that critical sites, such as vial stoppers, be disinfected by wiping them with sterile 70% isopropyl alcohol (IPA) and allowing it to dry. The use of sterile IPA is critical to prevent the introduction of microbial contamination into the vial. Non-sterile IPA is not appropriate for use on critical sites within the PEC, and other concentrations or agents like sterile water are not the specified standard.
Question 4: Upon receiving a new stock of medication vials, what is the FIRST step a technician should perform as part of the component handling process?
- Wipe each vial with a sporicidal agent.
- Place the vials directly into the buffer area storage.
- Visually inspect each vial for particulate matter, cracks, or defects. (Correct answer)
- Refrigerate the entire shipment immediately.
Correct answer: Visually inspect each vial for particulate matter, cracks, or defects.
Before any other handling or storage steps, all components must be visually inspected upon receipt to ensure their integrity. This includes checking for cracks, leaks, particulate matter, and verifying that the label is correct and the product is not expired. This initial inspection prevents compromised components from entering the compounding workflow.
Question 5: Which of the following techniques is recommended to prevent coring when inserting a needle into a vial's rubber stopper?
- Using the largest gauge needle possible to create a clean puncture.
- Inserting the needle quickly and directly at a 90-degree angle.
- Twisting the needle clockwise as it is inserted into the stopper.
- Inserting the needle with the bevel tip facing up at a 45-60 degree angle, then applying pressure to enter at 90 degrees. (Correct answer)
Correct answer: Inserting the needle with the bevel tip facing up at a 45-60 degree angle, then applying pressure to enter at 90 degrees.
The proper technique to minimize coring involves inserting the needle at a 45-60 degree angle with the bevel up. As the needle is advanced, pressure is applied while simultaneously bringing the needle to a 90-degree angle just as the bevel passes through the stopper. This slicing motion is less likely to shear off a piece of the stopper compared to a direct 90-degree puncture.
Question 6: According to USP <797>, once a single-dose vial has been punctured inside an ISO Class 5 environment, for how long may it be used to prepare Compounded Sterile Preparations (CSPs)?
- Up to 1 hour, after which it must be discarded.
- Up to 24 hours if stored at room temperature.
- Up to 12 hours from the time of initial puncture. (Correct answer)
- Indefinitely, as long as it remains in the PEC.
Correct answer: Up to 12 hours from the time of initial puncture.
The revised USP Chapter <797> states that a single-dose container that has been entered or punctured inside an ISO Class 5 Primary Engineering Control (PEC) may be used for up to 12 hours after the initial entry, provided it is stored under appropriate conditions. This allows for more efficient use of the component while maintaining microbial safety standards.
CSPT - Compounded Sterile Preparation Technician Medication and Component Handling Questions and Answers 1
A technician is unpacking a shipment of sterile components, including vials of a hazardous drug.
According to USP , where should the initial unpacking of this shipment occur?