By Gina Shaw
Pharmacy technicians play a key role in sterile compounding, including reconstitution, mixing and assembling of ingredients, executing sterile compounding procedures in compliance with USP guidelines and internal policies, accurately documenting compounding activities, and cleaning and maintaining compounding equipment. 

But all of those efforts may be wasted if the technicians are not properly supervised. That’s why pharmacists who serve as the designated person or in another supervisory role in the cleanroom should not only be prepared to oversee technicians in these tasks, but also to lead, motivate and encourage skill development, said Brian Blackman, CPhT, CSPT, a pharmacy technician training specialist with Option Care Health, during a session at APhA25, in Nashville, Tenn.

“While technicians handle preparation and operational tasks, pharmacists typically focus on oversight, clinical judgment and final product verification,” Mr. Blackman said. “By clearly delineating these roles, the workflow becomes more efficient, reduces the risk of errors and ensures compliance with legal and professional standards.”

Pharmacists’ responsibilities of oversight and supervision require ensuring that all compounding activities adhere to regulatory standards, such as USP General Chapters <797> and <800>, while clinical judgment includes assessing patient-specific factors such as allergies and medication interactions as well as the technician’s adherence to policies and procedures before approving compounded medications. Final verification involves confirming accuracy in preparation, labeling and documentation.

So what should pharmacists be looking for as they are evaluating technicians who are performing sterile compounding? Keep an eye out for both good practices and bad, Mr. Blackman said. On the good side:

1. Component evaluation. “Compounding personnel must ascertain before use that components for CSPs [compounded sterile products] are of the correct identity, appropriate quality, within expiry date and have been stored under appropriate conditions,” he said. “All packages must be reinspected to detect container breaks, looseness of the cap or closure, and deviation from the expected appearance, aroma and/or texture of the contents that might have occurred during storage. Sterile container closures must be visually reinspected to ensure that they are free from defects that could compromise sterility and that they are otherwise suitable for their intended use.”

2. Introduction of items into the primary engineering control (PEC) in accordance with USP standards. “USP states that just before any item is introduced into the PEC, it must be wiped with sterile 70% isopropyl alcohol using low-lint wipers and allowed to dry before use,” Mr. Blackman said.

3. First air usage. The unidirectional first air from the HEPA filter should be allowed to bathe all critical sites on the direct compound area,” he explained. “Syringe Luer lock, medication vials and sterile supplies must have their critical sites bathed in first air at all times. How the technician will hold a vial, dispensing pin, or needle and syringe is vital to not introducing contaminates to the CSP.”

4. Medication and supply placement. Medications must be compounded within the direct compounding area at all times. “Being too close to the HEPA screen or side walls could put your critical sites into what is known as turbulent or stagnant air, possibly allowing microorganisms to contaminate your CSP,” he said.

5. Sterile isopropyl alcohol usage on gloves. “This is so important for disinfection and removal of possible debris from a surface,” Mr. Blackman said. “Make sure that anytime your technician leaves the PEC they must reapply and allow it to dry before reentering the PEC.”

Mr. Blackman reported no relevant financial disclosures.

 Look for an expanded version of this article in our October print issue, which will feature a special section dedicated to sterile compounding compliance.