Compounding competency lab

Compounding Competency Lab Overview

This lab session brings together everything you have studied about non-sterile compounding (USP <795>), sterile compounding (USP <797>), and hazardous drug handling (USP <800>). You will be observed while you prepare one non-sterile preparation, one sterile admixture, and complete a media-fill test. Each task must be performed competently before you are signed off. Read this page carefully before you enter the compounding suite.

Preparation Before You Start

Review the master formulation record (MFR) for each assigned preparation before lab day. Confirm you know the beyond-use date (BUD), required personal protective equipment (PPE), and any hazardous drug classification. Gather and verify all ingredients, equipment, and labels at the start of each task — this is the compounding equivalent of a "rights" check. Never begin compounding without a complete MFR in hand.

Non-Sterile Preparation

Non-sterile compounding follows USP <795>. Common dosage forms include oral solutions, topical creams, ointments, troches, and suppositories. Your assigned preparation will be one of these.

Key steps you must demonstrate:

• Perform hand hygiene and don required PPE (gloves at minimum; additional PPE if ingredients are sensitizers).
• Weigh each ingredient on a calibrated balance and record the actual weight on the compounding record.
• Mix in the correct order described in the MFR (e.g., levigating a powder with a small amount of base before incorporating the full quantity).
• Transfer to a final container, label with all required elements including the assigned BUD, and complete the compounding record.
• Inspect the finished preparation for appearance, odor, and consistency before handing it to the supervising pharmacist.

Safety point: Never leave an open container of a hazardous ingredient unattended. If a spill occurs, follow the spill kit procedure documented in your facility's standard operating procedure (SOP).

Sterile Admixture

Sterile compounding follows USP <797>. Your admixture task will require you to work inside a primary engineering control (PEC) — typically a laminar airflow workbench (LAFW) for non-hazardous preparations. If the drug is classified as hazardous under USP <800>, you will use a biological safety cabinet (BSC) or isolator designed for that purpose.

Key steps you must demonstrate:

• Complete proper garbing in order: shoe covers, hair cover, face mask, hand hygiene, non-shedding gown, sterile gloves. Inspect gloves for tears.
• Clean and disinfect the PEC surface with sterile 70% isopropyl alcohol (IPA) using overlapping strokes from back to front and allow it to dry completely before placing any items inside.
• Place only what you need inside the PEC; do not block the HEPA-filtered air stream between the filter and your work zone.
• Swab each rubber septum with a sterile IPA swab and allow it to dry before inserting a needle.
• Withdraw the correct volume, check for particulate matter and color changes, and label the final container with drug name, concentration, volume, BUD, storage requirements, and patient information.
• Inspect the final product and present it to the pharmacist for a final check before it leaves the clean room.

Safety point: Never recap a needle by hand. Use a one-handed scoop technique or a needle disposal device. Report any needle stick immediately.

Media-Fill Test

The media-fill test (also called a process validation or broth fill test) is how you prove that your aseptic technique is reliable enough to protect patients from microbial contamination. Instead of a real drug, you use a sterile growth medium — typically soybean-casein digest (tryptic soy broth, TSB) — and perform your normal aseptic procedure. The filled units are then incubated at the required temperature and time specified by USP <797>. If turbidity (cloudiness) appears in any unit, it indicates contamination, and the test fails.

Key steps you must demonstrate:

• Don full garb as described above.
• Transfer the growth medium using your standard aseptic technique — the same technique you used for the real admixture.
• Seal and label each filled unit.
• Place units in incubation as directed by your instructor.
• Record your lot number, date, and unit count on the process validation log.

Results are typically read after incubation. Your competency sign-off for the media-fill test requires no visible growth in any filled unit after the incubation period.

Safety point: Treat the growth medium as you would any biologically active material. Dispose of all media-fill materials in the appropriate waste container per your facility SOP.

Completing the Compounding Record

For every preparation — sterile or non-sterile — you must complete a compounding record (also called a compounding log). This document includes the date, compounder's initials, pharmacist's initials, lot numbers of all ingredients, actual quantities used, equipment used, and any deviations from the MFR. An incomplete compounding record is a quality failure even if the product looks perfect.

Final Competency Expectations

Your instructor will use a standardized skills checklist for each task. You must receive a passing score on all steps — not just an average. Critical safety errors (needle recapping, skipping hand hygiene, failing to verify ingredients) result in an automatic needs-remediation rating. You may repeat any task once after remediation coaching. The media-fill test result is read by your instructor after incubation; no growth in any unit is required to pass.