Canadian Entry To Practice Sterile Products Flashcards

Which ISO class cleanroom is required for the preparation of sterile hazardous drugs in Canada?

Answer: ISO Class 5

ISO Class 5 (formerly Class 100) is required for the primary engineering control used to prepare sterile hazardous drugs.

What is the primary purpose of a biological safety cabinet (BSC) when preparing hazardous sterile products?

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.

According to NAPRA Model Standards, what is the beyond-use date (BUD) for a compounded sterile preparation stored at room temperature without sterility testing?

Answer: 24 hours

Without sterility testing, compounded sterile preparations stored at room temperature have a maximum BUD of 24 hours under NAPRA standards.

Which technique is used to check for particulate matter in a finished sterile preparation?

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.

What type of filter is used to sterilize a solution that cannot withstand heat sterilization?

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.

When performing hand hygiene before aseptic compounding, how long must the surgical scrub technique last?

Answer: 2–3 minutes

A 2–3 minute surgical scrub technique, including cleaning under fingernails, is required before garbing and entering the cleanroom.