CSPT Medication and Component Handling 5 — Questions and Answers
Question 1: When compounding a sterile preparation using a powdered drug that requires reconstitution, which diluent should be used unless otherwise specified?
- Bacteriostatic water for injection
- Sterile water for injection (SWFI) (Correct answer)
- Normal saline with preservatives
- Dextrose 5% in water (D5W)
Correct answer: Sterile water for injection (SWFI)
Sterile water for injection (SWFI) is the default diluent for reconstitution unless the manufacturer specifies an alternative, as it is preservative-free and sterile.
Question 2: Which practice best prevents cross-contamination when handling multiple hazardous drug preparations in a BSC?
- Preparing all hazardous drugs simultaneously to save time
- Cleaning the BSC with 70% IPA between each preparation (Correct answer)
- Using the same set of syringes for different drugs
- Placing all drug vials in the BSC at the beginning of the shift
Correct answer: Cleaning the BSC with 70% IPA between each preparation
Cleaning the BSC with 70% isopropyl alcohol between preparations prevents carryover contamination from one hazardous drug to another.
Question 3: A technician must compound a preparation requiring an ingredient with a known photosensitivity. Which handling method is appropriate?
- Use under bright fluorescent lighting for accurate measurement
- Wrap the final container in amber or opaque material and minimize light exposure (Correct answer)
- Refrigerate after compounding but light exposure during prep is acceptable
- Prepare quickly under standard lighting to reduce exposure time
Correct answer: Wrap the final container in amber or opaque material and minimize light exposure
Photosensitive drugs must be protected from light during compounding and storage by using amber containers or opaque wrapping.
Question 4: What is the purpose of performing a 'fingertip sampling' test during cleanroom training for sterile compounding personnel?
- To check for skin allergies to glove materials
- To verify proper gowning and aseptic hand technique by culturing fingertip samples (Correct answer)
- To measure glove thickness and integrity
- To determine if personnel are carriers of MRSA
Correct answer: To verify proper gowning and aseptic hand technique by culturing fingertip samples
Fingertip sampling cultures the fingertips post-gowning to verify that aseptic technique and gloving procedures adequately reduce bioburden.
Question 5: When labeling a compounded sterile preparation for a patient, which element is NOT required on the label per USP <797>?
- Beyond-use date and time
- Route of administration
- The compounder's DEA registration number (Correct answer)
- Storage conditions
Correct answer: The compounder's DEA registration number
A DEA registration number is required only for controlled substances, not on all CSP labels; required elements include BUD, route, and storage conditions.
Question 6: Which action should be taken if an ampule is found to have a hairline crack before use in sterile compounding?
- Use it if the crack does not extend to the liquid drug
- Discard the ampule and document the rejection (Correct answer)
- Filter the contents with a 5-micron filter to remove glass
- Seal the crack with sterile tape and proceed
Correct answer: Discard the ampule and document the rejection
A cracked ampule must be discarded and the rejection documented, as integrity cannot be guaranteed and contamination risk is unacceptable.
Question 7: What is the significance of an 'inhibitory residue test' for cleaning agents used in sterile compounding areas?
- It confirms the cleaning agent kills 99.9% of bacteria
- It verifies that cleaning agent residues will not interfere with sterility testing results (Correct answer)
- It measures how quickly the surface dries after cleaning
- It ensures the cleaning agent is compatible with ISO 5 requirements
Correct answer: It verifies that cleaning agent residues will not interfere with sterility testing results
Inhibitory residue testing ensures cleaning agent residues left on compounding surfaces will not falsely suppress microbial growth in sterility tests, ensuring accurate results.
When compounding a sterile preparation using a powdered drug that requires reconstitution, which diluent should be used unless otherwise specified?