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

Compounding non-hazardous IV admixtures

Answer

Storage of chemotherapy agents

Answer

Performing sterility testing

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

3,520 particles ≥0.5 µm per cubic meter

Answer

35,200 particles ≥0.5 µm per cubic meter

Answer

3,520,000 particles ≥0.5 µm per cubic meter

Question 3

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

Accepted Answer

0.22 micron

Answer

0.45 micron

Answer

1.0 micron

Answer

5.0 micron

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

To confirm that the compounded drug is free of particulate matter

Answer

To verify the potency of the active pharmaceutical ingredient

Answer

To measure osmolarity of the finished preparation

Question 5

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

Accepted Answer

Sterile gloves

Answer

Shoe covers

Answer

Hair cover

Answer

Face mask

Question 6

USP <800> applies to which category of drugs in sterile compounding?

Accepted Answer

Hazardous drugs including chemotherapy agents

Answer

All sterile preparations regardless of risk

Answer

Non-sterile compounded preparations only

Answer

Controlled substances dispensed in a cleanroom