When making medicines, the personnel must be kept as safe as the patients who will be treated with the drugs. With many active pharmaceutical ingredients (APIs), especially hazardous ones in powdered form, lab personnel must work with equipment that performs as designed. That performance—particularly in biosafety cabinets (BSCs)—can only be ensured if the equipment receives the required maintenance.
Scientists recognized long ago the danger of working with API powders. As an example, Cancer Care Ontario’s “A Quality Initiative of the Program in Evidence-Based Care (PEBC)” points out: “It is strongly recommended that oral cytotoxics be handled in a manner that avoids skin contact, liberation of aerosols or powdered medicine into the air, and cross-contamination with other medicines.” For this recommendation, the Cancer Care Ontario document pointed to a publication from 1997.
Keeping personnel safe when working with API powders requires a BSC or similar device. According to Duke University’s “Safe Handling of Hazardous Drugs,” a lab manager must “ensure that tasks involving hazardous drugs in powdered form are performed in a controlled area inside a chemical fume hood, biological safety cabinet (BSC, vertical flow hood), or other containment primary engineering control (C-PEC) as defined in USP 800 whenever feasible.” This set of guidelines adds, “Such tasks would include reconstitution of powders or crushing of tablets.”
Some manufacturers design specific platforms for these tasks. As an example, NuAire (Plymouth, MN) notes that its LabGard CYTO NU-581 Biosafety Cabinet “offers a safer environment for applications involving hazardous API powders through a three-tiered HEPA filtration system.”
The safety of a BSC or other device in hazardous-drug API-powder applications, however, depends on proper maintenance.
Best BSC Practices
When asked about the key maintenance steps for a BSC used with hazardous-drug API powders, Bill Peters, vice president of engineering at NuAire, points out three:
- Verify that airflow paths under the work surface are free of dust and debris.
- Perform routine certification as required in NSF/ANSI 49 Annex F:
- HEPA filter leak test
- downflow velocity test
- inflow velocity test
- airflow smoke patterns
- site installation assessment tests
- If a BSC is used in an active pharmacy, perform an airflow cleanliness test per CETA CAG-003 to verify ISO5 work zone airflow.
When these tasks look like more than a lab or organization wants to handle itself, other options should be considered. “Service contracts are a good idea for BSC certification, because it is required that a BSC be certified at least annually and sometimes semi-annually if used in a pharmacy,” Peters explains. “Service contracts also aid in stating minimum requirements for the certification personnel, such as being NSF-accredited for BSC certification as well as CETA-certified for sterile compounding facilities.”
When considering a service contract, Peters makes a useful suggestion: “The key point is to be sure that the requirements are clearly stated, so competitive bid proposals can be reviewed for each item as specified.”
So, for personnel working with hazardous-drug API powders, a lab or pharmacy needs the proper safety equipment and maintaining it. Getting that right requires rigor in overall lab or pharmacy processes and procedures.