CSPT - Compounded Sterile Preparation Technician Storage, Handling, and Transport Questions and Answers

Question 1

A technician needs to transport a compounded chemotherapy infusion bag from the pharmacy to a nursing unit on a different floor. To comply with USP <800> guidelines, which of the following transport methods is most appropriate?

Accepted Answer

Placing the bag inside a sealed, impact-resistant container clearly labeled as a hazardous drug.

Answer

USP <800> requires hazardous drugs (HDs) to be transported in a manner that prevents breakage and leakage. Using a sealed, labeled, impact-resistant container minimizes exposure risk to staff and the environment during transport. [8, 14] Pneumatic tube systems are generally discouraged for liquid HDs due to the risk of breakage and contamination. [7]

Question 2

A pharmacy's refrigerator is used for storing both sterile components and finished CSPs. According to USP <797>, which of the following is a mandatory practice for this storage unit?

Accepted Answer

The temperature must be monitored and documented at least once daily on days the pharmacy is open.

Answer

USP <797> requires that temperature-controlled storage areas, such as refrigerators, have their temperatures monitored and documented daily to ensure that medications are stored within their required stability ranges. [15, 18] This ensures the integrity and safety of the stored components and CSPs. Food and beverages are never permitted in medication storage units.

Question 3

Before moving supplies from the anteroom into the buffer area (ISO Class 7), which of the following is the correct procedure for handling items like bags of IV solution and vials?

Accepted Answer

Wiping down the outer surfaces of all supplies with a sporicidal agent or sterile 70% isopropyl alcohol.

Answer

To prevent the introduction of contaminants into the cleanroom suite, all supplies must be uncartoned and have their outer surfaces wiped down with a suitable disinfectant (like sterile 70% IPA) before being passed from the anteroom to the buffer area. [6, 17] Cardboard and other particle-shedding materials are not allowed in the buffer area or PEC.

Question 4

A shipment of medication arrives with the manufacturer's storage instruction listed as "Store at controlled room temperature." According to the USP definition, this corresponds to which temperature range?

Accepted Answer

20°C to 25°C (68°F to 77°F).

Answer

USP General Chapter <659> defines "controlled room temperature" as the temperature thermostatically maintained between 20°C and 25°C (68°F to 77°F). [1, 2, 3] While excursions between 15°C and 30°C are permitted, the core definition is the 20-25°C range. [3, 4]

Question 5

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?

Accepted Answer

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

Answer

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]

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Storage, Handling, and Transport Questions and Answers