Air contamination, syringe contamination, and cross-contamination when using an automatic compounding device for sensitizing drugs

Abstract

Abstract Objectives To measure cross-contamination between batches of different sensitizing drugs, contamination on the outside of compounded syringes, and drug concentrations in environmental air when using an automated compounding device. Methods One batch of piperacillin/tazobactam syringes followed by one batch of meropenem syringes were compounded daily for three consecutive days by one operator. For each batch two hundred syringes were filled. During each batch, three stationary air samples (two inside and one outside the compounding device), and one personal air sample were collected. At the end of the compounding process, the outside of 40 syringes was tested for drug contamination by wipe sampling. The drug compounded was checked for cross-contamination with the other drug compounded in the previous batch. Liquid chromatography tandem mass spectrometry was used for the analysis of piperacillin and meropenem. Results Piperacillin was measured in environmental air inside the device (8.1–335 ng/m3), outside the device (5.2–21 ng/m3), and in the personal air samples of the operator (15 and 155 ng/m3) during two batches. Meropenem was not detected during meropenem compounding. Piperacillin was found in the air samples of the operator during two batches (12 and 15 ng/m3). Meropenem was not detected in any of the air samples. The drug compounded was found on the outside of the syringes for all batches (piperacillin: 1.35–30 ng/cm2; meropenem: 0.07–0.65 ng/cm2). Piperacillin was detected on the syringes in all meropenen batches (0.56–11 ng/cm2), and meropenen in two piperacillin batches (0.07 and 0.46 ng/cm2). The drug solutions show no cross-contamination with the other drug for any of the batches. Conclusions Cross-contamination was not found and the drug concentrations in environmental air were below the Occupational Exposure Limit of 0.1 mg/m3. The automatic compounding device meets the criteria for a safe compounding of sensitizing drugs for patient and operator.