Canadian Entry To Practice Canadian Entry To Practice Sterile Products 1

Question 1

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

Accepted Answer

ISO Class 5

Answer

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?

Accepted Answer

To protect the product, operator, and environment

Answer

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?

Accepted Answer

24 hours

Answer

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?

Accepted Answer

Visual inspection under light

Answer

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?

Accepted Answer

0.22-micron membrane filter

Answer

A 0.22-micron (or smaller) membrane filter is used for terminal sterilization of heat-sensitive solutions through filtration.