Introduction: 

In pharmacy, especially in highly clinical settings, we tend to focus too much on regulation, looking for compliance security. But what about randomly observing the actual compounding workflow during the day to establish if our “state of control” is maintained and compounding practices are consistent with and fostering a culture of patient safety? compliance in the timing and results of EM and the clarity of our SOPs are important, but so is how we all understand and execute our process during active time.

I am referring to what happens inside the buffer. Compounding activities may not be visible in some institutions due to cleanroom configuration and/or design. Are the processes themselves NOT supportive of SOPs and good aseptic technique? Here are some areas where we can focus on fine-tuning aseptic processes in hospitals and infusion centers. These require direct observation by designated persons and certified pharmacy technicians with compounding area oversight.

1. Materials Management

Disinfecting objects before introduction into PECs. Observe during busy times.

1. Observations during batch or individual CSPs. What does compliance look like? Each component, including vials, supplies, and containers, gets wiped with sterile IPA before introduction.

2. Hand Hygiene

Hand hygiene is maintained throughout the compounding process. Gloves are exchanged after leaving the buffer and returning to compounding. 

1. Gloves are sanitized with IPA during the compounding process and changed approximately every 30 minutes or when visibly torn or soiled. Gloved hands are maintained inside the PEC and re-sanitized if removed from the HEPA-filtered zone. Also, excursions outside the buffer room should evoke a glove change. (Note: This is why the optimal location for a pass-thru is from the unclassified pharmacy area directly into the buffer to promote efficiency and trips out of the buffer to get compounding materials).

2. Train staff to look for natural pauses in their compounding process as a signal to re-sanitize gloves. For instance, in a media-fill test, repetitive, manipulative steps could begin or end with a gloved-hand hygiene step. This can also be performed after a batch of identical or individual CSPs is mixed. Then, hand hygiene follows before continuing with the next item or batch.

3. Line Clearance

Check whether more than one CSP type is compounded simultaneously in the same run.

 As a general rule, you want to reinforce the “line-clearance” principle in which each individual CSP type or batch is processed, and the deck is “cleared” of all components from the previous compounding run and wiped clean with IPA. Note: You can make an exception if a component requires a long reconstitution time (such as daptomycin) and the tech or pharmacist wants to perform the reconstitution step and set it aside to be more efficient. If your cleanroom has more than one hood, you may batch at one hood and compound “stats” at the other.

4. Direct Compounding Area(s)

Determine if the operator clearly understands what zones in the PEC are acceptable as DCAs. A 6-foot hood has two DCAs that can be utilized. Conversely, you could say such a hood would have one large DCA. Is the deck organized to favor unidirectional flow, or are there components blocking airflow or creating turbulent currents? Where in the deck are supplies and components placed? Is there a small bin for paper waste generated during compounding? Is the operator consistently working left-to-right or right-to-left?

5. Horizontal v. Vertical PEC Airflow

Observe if staff understands the difference between horizontal and vertical flow dynamics and how hand positioning and component placement are modified based on the location of the HEPA-filtered air supply. This may offer an opportunity to introduce smoke visualization to give compounders a “visual memory” of how air flows in their hood. Smoke pattern visualization can be added during aseptic technique competency assessment to determine proper hand positioning to maximize exposure of critical sites to first air.

6. Compounding Management Hardware Placement

Is your workflow management hardware touchscreen within the PEC or in worse than ISO-5 air? If so, maintaining gloved hand hygiene during compounding can be an issue. Breaches will inevitably occur, and gloved hand hygiene will be difficult to maintain. Determine if operators have difficulty being efficient due to excessive in and out movements from the touch screen to the hood deck. You may ask your hardware vendor if they have options, such as brackets to extend touchscreens and bring the work closer to the hood’s DCA.

7. Other Considerations

1. If all the above are performed, how much time is it adding to prep time? Is our room configuration conducive to efficient workflows? What is the policy on emergently needed CSPs that may save life, limb, or brain? Are we comfortable with immediate-use compounding outside of the cleanroom to address such emergencies? Should a policy be drafted to cover compounding in non-classified pharmacy areas during emergencies? This can “take the edge off” and prevent stressful emergent compounding within the cleanroom (see previous article, “Emergent Drug Compounding…“).

8. Engagement

Compounding techs and pharmacists should periodically meet with DPs to discuss compounding principles, regulatory updates, patient safety initiatives, workflow issues, and compounding errors. This activity aims to maintain morale and engagement and foster leadership within your sterile compounding team.

9. DP Presence Within Compounding Areas

DPs must do “rounds” by entering the room periodically to evaluate optimal working conditions. How long are DPs staying? Are they compounding or only observing? Having a first-hand knowledge of what it “feels” like inside the room is critical. It does not have to be long but it is better if this is done during a busy time. Having leadership alongside staff will provide real data as to working conditions and other important aspects affecting efficiency.

What is your experience?

Can you share your best practices and how you engage compounders to foster a safety culture? Share your feedback and comments. We will be sharing specific details of some of the above recommendations in future blog releases.

Conclusion

USP 797 does not prescribe the educational methodology for introducing new personnel to sterile compounding. A workshop is an immersive and interactive way to integrate didactic training and practical skills. It must contain all the basic skills needed to perform simple compounding operations. All training must always be followed up with opportunities for live compounding supervised by an experienced compounder prior to release to work.  For assistance designing or hosting a sterile compounding workshop, contact Seven97 Training Solutions by email: luis.hernandez@my797trainer.com, filling a contact form at the following webpage www.seven97training.com, or call (305) 972-2595.

Released April 2025

About the Author

Luis Hernandez, RPh, BCSCP, is a certified sterile compounding pharmacist and the founder of Seven97 Training Solutions. Dedicated to advancing USP 797 pharmaceutical training, validation, and certification, Luis aims to promote and inspire excellence in aseptic processing, medication and patient safety, and regulatory compliance.

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