Pharmacy Pharmacy Sterile Compounding 2

Question 1

What is a biological safety cabinet (BSC) Class II Type B2 used for in pharmacy?

Accepted Answer

Compounding hazardous drugs that require total exhaust to the outside

Answer

A Class II Type B2 BSC is a total-exhaust cabinet that expels 100% of its air to the outside, making it suitable for compounding hazardous drugs that should not be recirculated.

Question 2

What is the minimum particle count specification for an ISO Class 7 buffer room used in sterile compounding?

Accepted Answer

352,000 particles ≥0.5 µm per cubic meter

Answer

An ISO Class 7 cleanroom allows a maximum of 352,000 particles ≥0.5 µm per cubic meter, which is the standard for buffer rooms housing PECs for sterile compounding.

Question 3

Which filter pore size is used for sterilization by filtration of a CSP?

Accepted Answer

0.22 micron

Answer

A 0.22-micron (0.2-micron) membrane filter is the standard pore size for sterilizing filtration, as it removes bacteria and most other microorganisms.

Question 4

What is the purpose of an endotoxin (LAL) test for CSPs?

Accepted Answer

To detect bacterial endotoxins that can cause fever and septic shock if injected

Answer

The Limulus Amebocyte Lysate (LAL) test detects bacterial endotoxins (pyrogens) in CSPs intended for injection, since endotoxins can cause severe febrile reactions even in sterile products.

Question 5

Which garbing item is donned LAST when entering an ISO Class 7 cleanroom?

Accepted Answer

Sterile gloves

Answer

Sterile gloves are always the final item donned in the garbing sequence to prevent contamination of gloves by touching other surfaces during the process.

Pharmacy Practice Test

Pharmacy Practice Test

Pharmacy Pharmacy Sterile Compounding 2