PTCE Compounding 3

Question 1

Which ISO class cleanroom is required for the preparation of Category 2 CSPs (compounded sterile preparations)?

Accepted Answer

ISO Class 5

Answer

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>?

Accepted Answer

14 days

Answer

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?

Accepted Answer

Water-soluble base

Answer

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:

Accepted Answer

Tap the syringe barrel and push the plunger gently to expel bubbles

Answer

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?

Accepted Answer

Absorption base (anhydrous lanolin)

Answer

Absorption bases like anhydrous lanolin can incorporate water and are suitable for hydrophilic active ingredients.

(PTCE) Pharmacy Technician Certification Exam Practice Test