CSPT - Compounded Sterile Preparation Technician Non-Sterile to Sterile Compounding Questions and Answers

Question 1

A technician must prepare a sterile solution from a non-sterile bulk powder known to be heat-labile. Which method of sterilization is most appropriate for the final preparation?

Accepted Answer

Sterilization by filtration using a 0.22-micron filter

Answer

Dry heat sterilization in a depyrogenating oven

Answer

Steam sterilization in an autoclave

Answer

Ethylene oxide gas sterilization

Question 2

When compounding a parenteral product from a non-sterile bulk drug powder, why is performing a Bacterial Endotoxin Test (BET) a critical quality control step?

Accepted Answer

It detects fever-causing pyrogens from bacterial cell walls.

Answer

It confirms the absence of all viable microorganisms in the final product.

Answer

It measures the concentration of the active pharmaceutical ingredient.

Answer

It ensures the final solution has the correct pH level.

Question 3

A pharmacy compounds a batch of sterile ophthalmic drops from non-sterile ingredients and sterilizes the final solution by filtration. The batch does not undergo sterility testing. According to USP Chapter <797> guidelines for Category 2 CSPs, what is the maximum beyond-use date (BUD) if the batch is stored in a refrigerator?

Accepted Answer

7 days

Answer

24 hours

Answer

14 days

Answer

30 days

Question 4

A technician is preparing for a non-sterile to sterile compounding session and needs to ensure the glass vials used will be free of both microbial life and pyrogens. Which piece of equipment is required to achieve this?

Accepted Answer

Depyrogenating oven

Answer

Autoclave

Answer

Class II Biological Safety Cabinet

Answer

Incubator

Question 5

Which of the following quality control measures is required by USP <797> to assign a beyond-use date (BUD) of up to 180 days to a batch of CSPs made from non-sterile ingredients?

Accepted Answer

Passing a sterility test performed on the batch

Answer

Visual inspection by a pharmacist before dispensing

Answer

Performing media-fill testing annually

Answer

Passing a Bacterial Endotoxin Test (BET)

Question 6

A hospital pharmacy is preparing a large batch of a heat-stable electrolyte solution from bulk, non-sterile powders. The plan is to terminally sterilize the CSPs after they have been packaged into their final sealed glass vials. What is the most common and effective method for this process?

Accepted Answer

Steam sterilization (autoclaving)

Answer

Irradiation with ultraviolet (UV) light

Answer

Aseptic filtration into the vials

Answer

Dry heat sterilization

A technician must prepare a sterile solution from a non-sterile bulk powder known to be heat-labile.Which method of sterilization is most appropriate for the final preparation?

A technician must prepare a sterile solution from a non-sterile bulk powder known to be heat-labile.
Which method of sterilization is most appropriate for the final preparation?