Canadian Entry To Practice Canadian Entry To Practice Sterile Products 1 — Questions and Answers
Question 1: Which ISO class cleanroom is required for the preparation of sterile hazardous drugs in Canada?
- ISO Class 3
- ISO Class 5 (Correct answer)
- ISO Class 7
- ISO Class 8
Correct answer: ISO Class 5
ISO Class 5 (formerly Class 100) is required for the primary engineering control used to prepare sterile hazardous drugs.
Question 2: What is the primary purpose of a biological safety cabinet (BSC) when preparing hazardous sterile products?
- To maintain product sterility only
- To protect the product, operator, and environment (Correct answer)
- To speed up preparation time
- To reduce medication errors
Correct answer: To protect the product, operator, and environment
A BSC protects the product from contamination while also protecting the operator and the environment from hazardous drug exposure.
Question 3: According to NAPRA Model Standards, what is the beyond-use date (BUD) for a compounded sterile preparation stored at room temperature without sterility testing?
- 12 hours
- 24 hours (Correct answer)
- 48 hours
- 72 hours
Correct answer: 24 hours
Without sterility testing, compounded sterile preparations stored at room temperature have a maximum BUD of 24 hours under NAPRA standards.
Question 4: Which technique is used to check for particulate matter in a finished sterile preparation?
- Endotoxin testing
- Visual inspection under light (Correct answer)
- Osmolality testing
- pH measurement
Correct answer: Visual inspection under light
Visual inspection under adequate light against a contrasting background is the standard method for detecting particulate matter in sterile preparations.
Question 5: What type of filter is used to sterilize a solution that cannot withstand heat sterilization?
- HEPA filter
- 0.22-micron membrane filter (Correct answer)
- 0.45-micron depth filter
- Activated carbon filter
Correct answer: 0.22-micron membrane filter
A 0.22-micron (or smaller) membrane filter is used for terminal sterilization of heat-sensitive solutions through filtration.
Question 6: When performing hand hygiene before aseptic compounding, how long must the surgical scrub technique last?
- 30 seconds
- 1 minute
- 2–3 minutes (Correct answer)
- 5–6 minutes
Correct answer: 2–3 minutes
A 2–3 minute surgical scrub technique, including cleaning under fingernails, is required before garbing and entering the cleanroom.
Canadian Entry To Practice Canadian Entry To Practice Sterile Products 1
Which ISO class cleanroom is required for the preparation of sterile hazardous drugs in Canada?