PTCE Compounding 3 — Questions and Answers
Question 1: Which ISO class cleanroom is required for the preparation of Category 2 CSPs (compounded sterile preparations)?
- ISO Class 5 (Correct answer)
- ISO Class 7
- ISO Class 8
- ISO Class 3
Correct answer: ISO Class 5
All sterile compounding must occur in an ISO Class 5 primary engineering control (PEC), such as a laminar airflow workbench or BSC.
Question 2: What is the maximum BUD for an aqueous oral compounded preparation stored at room temperature under USP <795>?
- 14 days (Correct answer)
- 30 days
- 6 months
- 1 year
Correct answer: 14 days
USP <795> limits water-containing oral formulations stored at room temperature to a BUD of 14 days.
Question 3: Polyethylene glycol (PEG) suppository bases are classified as which type?
- Water-soluble base (Correct answer)
- Fatty or oleaginous base
- Emulsion base
- Hydrogel base
Correct answer: Water-soluble base
PEG bases are water-soluble and dissolve in rectal fluid rather than melting at body temperature.
Question 4: During preparation of a sterile IV admixture, a pharmacy technician must remove air bubbles from a syringe. The best technique is to:
- Tap the syringe barrel and push the plunger gently to expel bubbles (Correct answer)
- Shake the syringe vigorously
- Insert an additional needle to release air
- Allow the syringe to sit upright for 10 minutes
Correct answer: Tap the syringe barrel and push the plunger gently to expel bubbles
Tapping and gentle plunger pressure consolidates and expels air from the syringe without compromising sterility.
Question 5: Which ointment base is MOST appropriate when the goal is to absorb water and deliver hydrophilic drugs?
- Absorption base (anhydrous lanolin) (Correct answer)
- Hydrocarbon base (petrolatum)
- Water-soluble base (PEG)
- Emulsion base (O/W)
Correct answer: Absorption base (anhydrous lanolin)
Absorption bases like anhydrous lanolin can incorporate water and are suitable for hydrophilic active ingredients.
Question 6: A 'clean room' anteroom in a sterile compounding facility is typically maintained at which ISO classification?
- ISO Class 8 (Correct answer)
- ISO Class 5
- ISO Class 6
- ISO Class 3
Correct answer: ISO Class 8
The anteroom where personnel gown and materials are staged is generally maintained at ISO Class 8.
Question 7: Which preservative is commonly used in multi-dose compounded ophthalmic preparations?
- Benzalkonium chloride (BAK) (Correct answer)
- Methylparaben
- Benzyl alcohol
- Thimerosal
Correct answer: Benzalkonium chloride (BAK)
BAK is the most widely used preservative in ophthalmic solutions due to its broad-spectrum antimicrobial activity.
PTCE Compounding 3
Which ISO class cleanroom is required for the preparation of Category 2 CSPs (compounded sterile preparations)?