Unit 3: Sterile Compounding

• Topic 01

  USP <797> — Standards for Sterile Preparations

  43 questions
• Topic 02

  ISO Cleanroom Classifications and Ante-Room Requirements

  48 questions
• Topic 03

  Laminar Airflow Workbench (LAFW) and Biological Safety Cabinet (BSC) Operation

  45 questions
• Topic 04

  Aseptic Technique — Gowning, Gloving, and Hand Hygiene

  45 questions
• Topic 05

  IV Admixture Preparation — Large-Volume Parenterals and Piggybacks

  45 questions
• Topic 06

  Beyond-Use Dates (BUDs) for Sterile Preparations

  45 questions
• Topic 07

  Hazardous Drug Handling — NIOSH List, Closed System Transfer Devices

  45 questions

A few questions from this unit, with the answer and a full explanation. The complete bank is available when you start practising.

1. A pharmacy technician is preparing non-hazardous IV admixtures. Which primary engineering control is most appropriate?

   • A
     A Class II Type B2 BSC, which exhausts 100% of air to the outside and is required for all sterile compounding
   • B
     A horizontal laminar airflow workbench (H-LAFW), which provides ISO 5 HEPA-filtered air from back to front across the work surface for product protection
     Correct answer
   • C
     A segregated compounding area (SCA) without any PEC, since non-hazardous admixtures do not require ISO 5 conditions
   • D
     A negative-pressure CACI, which provides both ISO 5 conditions and containment for all drug preparations
   Explanation

   For non-hazardous sterile compounding, a horizontal LAFW (H-LAFW) is the standard PEC. The H-LAFW has a HEPA filter at the back of the cabinet, producing air that flows horizontally from the filter toward the operator. This unidirectional ISO 5 airflow sweeps room-air contamination away from the open containers and critical zone, protecting the product. A Class II Type B2 BSC is reserved for volatile hazardous drug compounding. A CACI is a negative-pressure containment isolator used for hazardous drugs. Key takeaway: H-LAFW = appropriate PEC for non-hazardous IV admixture preparation; Class II BSC and CACI are reserved for hazardous drug compounding.

2. A Category 2 pharmacy performs USP <71> sterility testing on a batch and obtains a passing result. The pharmacist labels each CSP with a 30-day CRT BUD. An inspector finds that container closure integrity testing (CCIT) was not performed. What does this mean for the extended BUD claim?

   • A
     CCIT is an optional enhancement that does not affect the validity of the 30-day BUD from sterility testing alone
   • B
     The inspector is incorrect; CCIT is only required for frozen preparations, not CRT-stored CSPs
   • C
     Without CCIT, the extended BUD claim is potentially incomplete; CCIT is typically required alongside sterility testing to support extended BUDs because it confirms the container seal prevents microbial ingress over the claimed BUD period
     Correct answer
   • D
     The extended BUD is fully valid; USP <797> only requires sterility testing, not CCIT, for the 30-day CRT BUD
   Explanation

   USP <797> specifies that supporting an extended BUD typically requires both sterility testing (USP <71>) and container closure integrity testing (CCIT), along with stability data. CCIT confirms that the container's seal will maintain its integrity and prevent microbial ingress throughout the entire claimed BUD period. If only sterility testing was performed, the pharmacy cannot demonstrate that the container will remain sterile for 30 days, even if it was sterile at the time of testing. Key takeaway: extended BUD claims require both sterility testing (USP <71>) and CCIT; sterility testing alone demonstrates the preparation was sterile at testing time but not that it will remain sealed and sterile through the full BUD.

3. What is gloved fingertip sampling and when is it performed?

   • A
     Gloved fingertip sampling is a method for testing the sterility of a new batch of sterile gloves before they are put into service
   • B
     Gloved fingertip sampling is a technique for sampling the IV bag additive port by pressing a gloved finger against the port to check for contamination
   • C
     Gloved fingertip sampling is a competency assessment in which a compounder presses their sterile-gloved fingertips onto contact agar plates immediately after gowning; the plates are incubated to detect microbial contamination from the gowning process
     Correct answer
   • D
     Gloved fingertip sampling is a test of glove integrity performed by inflating each glove with air to detect pinhole leaks before compounding begins
   Explanation

   Gloved fingertip sampling (GFS) is a hands-on competency test required by USP <797>. After completing the gowning procedure (including donning sterile gloves), the compounder immediately presses all 10 fingertips onto separate sections of trypticase soy agar contact plates. The plates are incubated at appropriate temperatures for 48–72 hours. Any colony growth indicates that the gowning process did not achieve adequate sterility at the fingertips — the most critical area for contamination risk during sterile compounding. Key takeaway: Gloved fingertip sampling = immediately after gowning; tests whether the donning process achieved sterile fingertips; any growth = failed test.