CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 4 — Questions and Answers
Question 1: According to USP <797>, what is the BUD for a Category 1 CSP stored at controlled room temperature when prepared in a non-ISO-classified environment?
- 12 hours (Correct answer)
- 24 hours
- 72 hours
- 6 hours
Correct answer: 12 hours
Category 1 CSPs prepared outside of ISO-classified environments have a BUD of 12 hours at controlled room temperature.
Question 2: A CSP is prepared from multiple non-sterile ingredients. Under USP <797>, this preparation is classified as which sterility risk level prior to sterilization?
- Category 1
- Category 2
- Category 3 (Correct answer)
- High-risk
Correct answer: Category 3
CSPs prepared from non-sterile ingredients require sterilization and are classified as Category 3 under USP <797> (2023 revision).
Question 3: Which factor does NOT directly affect the chemical stability and BUD assignment of a compounded sterile preparation?
- pH of the solution
- Container closure system
- Technician certification level (Correct answer)
- Exposure to light
Correct answer: Technician certification level
Technician certification level is a personnel qualification factor and does not directly affect the chemical stability of a CSP.
Question 4: A pharmacy is assigning a BUD based on published stability data. The referenced study was conducted at 5°C, but the CSP will be stored at 25°C. What is the appropriate action?
- Use the published BUD directly
- Extrapolate the BUD using the Q10 rule to adjust for temperature (Correct answer)
- Assign the maximum default BUD allowed by USP <797>
- Discard the reference and use sterility testing data only
Correct answer: Extrapolate the BUD using the Q10 rule to adjust for temperature
The Q10 rule can be applied to extrapolate BUD from stability data obtained at a different temperature, accounting for increased degradation rates at higher temperatures.
Question 5: An admixture of ampicillin in NS is prepared. The pharmacist notes that the solution turns yellow over time. This color change most likely indicates:
- Normal reconstitution artifact
- Hydrolytic degradation of the beta-lactam ring (Correct answer)
- Particulate matter formation
- pH adjustment by the diluent
Correct answer: Hydrolytic degradation of the beta-lactam ring
Yellowing of ampicillin solutions is a sign of hydrolytic degradation of the beta-lactam ring, indicating loss of potency.
Question 6: For a CSP that lacks applicable stability data, USP <797> default BUDs are assigned. Which condition results in the longest allowable default BUD for a Category 2 CSP?
- Room temperature storage
- Refrigerated storage
- Frozen storage (Correct answer)
- Incubator storage at 37°C
Correct answer: Frozen storage
Frozen storage at ≤-25°C allows the longest default BUD for Category 2 CSPs because low temperatures slow microbial growth and chemical degradation.
Question 7: A total parenteral nutrition (TPN) admixture contains calcium and phosphate. The primary stability concern when assigning BUD is:
- Microbial contamination from multiple additives
- Calcium-phosphate precipitation (Correct answer)
- Lipid peroxidation
- Amino acid crystallization
Correct answer: Calcium-phosphate precipitation
Calcium-phosphate precipitation is the critical stability concern in TPN admixtures, potentially causing fatal pulmonary emboli if infused.
CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 4
According to USP , what is the BUD for a Category 1 CSP stored at controlled room temperature when prepared in a non-ISO-classified environment?