CSPT - Compounded Sterile Preparation Technician Medication and Component Handling Questions and Answers 2 — Questions and Answers
Question 1: What is the correct technique for withdrawing medication from a single-dose vial?
- Insert needle at 90 degrees without swabbing
- Swab septum with 70% IPA, allow to dry, then insert needle using aseptic technique (Correct answer)
- Swab septum with tap water then insert needle
- Remove cap and pour contents into mixing container
Correct answer: Swab septum with 70% IPA, allow to dry, then insert needle using aseptic technique
The septum must be swabbed with sterile 70% IPA and allowed to dry completely before needle insertion.
Insert the needle at a 45-60 degree angle through the septum with the bevel up to prevent coring. Single-dose vials must be used within 1 hour of initial puncture and any remaining contents discarded.
Question 2: How should ampules be opened to minimize the risk of glass particulate contamination?
- Break with bare fingers toward the HEPA filter
- Score if needed, wrap neck with alcohol pad, and snap away from the HEPA filter (Correct answer)
- Use scissors to cut the top off
- Heat the neck with a flame and pull apart
Correct answer: Score if needed, wrap neck with alcohol pad, and snap away from the HEPA filter
Ampules should be scored, the neck wrapped with a sterile alcohol pad for protection, and snapped away from the HEPA filter.
After opening, a filter needle (typically 5-micron) MUST be used to withdraw contents. The filter needle must then be replaced with a regular needle before injecting into the final container.
Question 3: What is the maximum time a multi-dose vial may be used after initial puncture according to USP 797?
- 24 hours
- 48 hours
- 28 days unless otherwise specified by the manufacturer (Correct answer)
- Indefinitely if stored properly
Correct answer: 28 days unless otherwise specified by the manufacturer
Multi-dose vials may be used for up to 28 days after initial puncture unless the manufacturer specifies shorter dating.
The date and time of initial puncture must be marked on the vial. MDVs should never be stored inside the PEC. If visibly contaminated, discard immediately regardless of the 28-day dating.
Question 4: When reconstituting a powdered drug, what must be verified before adding the diluent?
- The color of the powder
- The correct diluent type, volume, and compatibility as specified by manufacturer or formulation record (Correct answer)
- The weight of the empty vial
- The brand name matches preferred formulary
Correct answer: The correct diluent type, volume, and compatibility as specified by manufacturer or formulation record
Before reconstitution, verify the correct diluent type and volume as these are NOT interchangeable and affect drug stability and potency.
Using the wrong diluent can cause precipitation, degradation, or altered pharmacokinetics. After reconstitution, the vial must be labeled with the new BUD based on reconstituted product stability data.
Question 5: What is the purpose of performing a visual inspection of a completed CSP?
- To verify label design meets marketing standards
- To detect visible particulate matter, discoloration, container-closure integrity issues, and confirm proper volume (Correct answer)
- To photograph the product
- To check the drug is the correct brand name
Correct answer: To detect visible particulate matter, discoloration, container-closure integrity issues, and confirm proper volume
Visual inspection detects particulate contamination, color changes, leaking or improperly sealed containers, and incorrect fill volumes.
The inspection should be performed against both a light and dark background. While visual inspection cannot detect microbial contamination, it catches many types of errors and physical defects.
Question 6: How should ingredients be introduced into the PEC to maintain aseptic conditions?
- Bring all items in original shipping boxes
- Decontaminate outer surfaces with sterile 70% IPA, remove outer packaging in ante-area, and place items without blocking airflow (Correct answer)
- Place items directly from storage shelves
- No decontamination needed if commercially sterile
Correct answer: Decontaminate outer surfaces with sterile 70% IPA, remove outer packaging in ante-area, and place items without blocking airflow
Components must have outer packaging removed in the ante-area, surfaces wiped with sterile 70% IPA, then placed in the PEC without blocking airflow.
In a horizontal LAFW, items should be placed at least 6 inches from the back HEPA filter and sides. Large items go to the sides. The PEC should not be overcrowded as excessive items disrupt laminar airflow.
CSPT - Compounded Sterile Preparation Technician Medication and Component Handling Questions and Answers 2
What is the correct technique for withdrawing medication from a single-dose vial?