By Eric S. Kastango, MBA, RPh, FASHP

Pharmacy Purchasing & Products: How should the use of cell phones in a USP -compliant cleanroom be addressed?

Eric Kastango: While the argument can certainly be made that USP does not explicitly forbid cell phones in the cleanroom (of course, neither does it explicitly permit them), you must ensure that your policies and procedures mirror the intent of ’s requirements to prevent harm and death to patients treated with CSPs.

Cell phones in the cleanroom raise two issues: First, calls, emails, or texts are a distraction from the important work at hand, and second, touching the phone keypad and then returning to compounding can introduce contamination into the sterile environment. As stated in Appendix I, only materials required for compounding activities to be performed shall be brought into the room. Clearly, a staff member’s cell phone (or MP3 player) is not required material.

Furthermore, among the suggested standard operating procedures in , #20 states, “All procedures are performed in a manner designed to minimize the risk of touch contamination.” Reaching under the gown to access and then manipulate the cell phone interferes with aseptic technique. This holds true for staff members skipping a song on their iPod or adjusting their ear buds; all of these are manipulations that compromise aseptic processes.
Unless a staff member is waiting for a critically important call from a family member, no cell phones should be allowed in the compounding area.

As a manager, it is your responsibility to impart the importance of sterile technique in compounding. While managing people and instituting new policies can be difficult, compounding policies are about ensuring vigilance and doing what is best for the patient. When there is resistance to a practice, ask your staff to consider how the patient receiving the compounded preparation might feel about the practice.

Eric S. Kastango, MBA, RPh, FASHP, is the president, CEO, and owner of Clinical IQ, LLC, a provider of customized process and educational strategies for the pharmaceutical, medical device, and health care industries. A member of USP’s Sterile Compounding Committee, he has practiced in the field of both hospital and home care pharmacy since 1980.

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