Pharmacy Pharmacy Sterile Compounding 2 — Questions and Answers
Question 1: What is a biological safety cabinet (BSC) Class II Type B2 used for in pharmacy?
- Compounding hazardous drugs that require total exhaust to the outside (Correct answer)
- Compounding non-hazardous IV admixtures
- Storage of chemotherapy agents
- Performing sterility testing
Correct answer: Compounding hazardous drugs that require total exhaust to the outside
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?
- 352,000 particles ≥0.5 µm per cubic meter (Correct answer)
- 3,520 particles ≥0.5 µm per cubic meter
- 35,200 particles ≥0.5 µm per cubic meter
- 3,520,000 particles ≥0.5 µm per cubic meter
Correct answer: 352,000 particles ≥0.5 µm per cubic meter
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?
- 0.22 micron (Correct answer)
- 0.45 micron
- 1.0 micron
- 5.0 micron
Correct answer: 0.22 micron
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?
- To detect bacterial endotoxins that can cause fever and septic shock if injected (Correct answer)
- To confirm that the compounded drug is free of particulate matter
- To verify the potency of the active pharmaceutical ingredient
- To measure osmolarity of the finished preparation
Correct answer: To detect bacterial endotoxins that can cause fever and septic shock if injected
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?
- Sterile gloves (Correct answer)
- Shoe covers
- Hair cover
- Face mask
Correct answer: Sterile gloves
Sterile gloves are always the final item donned in the garbing sequence to prevent contamination of gloves by touching other surfaces during the process.
Question 6: USP <800> applies to which category of drugs in sterile compounding?
- Hazardous drugs including chemotherapy agents (Correct answer)
- All sterile preparations regardless of risk
- Non-sterile compounded preparations only
- Controlled substances dispensed in a cleanroom
Correct answer: Hazardous drugs including chemotherapy agents
USP <800> specifically establishes standards for safe handling of hazardous drugs — including antineoplastics, antivirals, and hormone agents — to protect healthcare workers and patients.
Pharmacy Pharmacy Sterile Compounding 2
What is a biological safety cabinet (BSC) Class II Type B2 used for in pharmacy?