Assessment of occupational exposure to nebulized isopropyl alcohol as disinfectant during aseptic compounding of parenteral cytotoxic drugs in cleanrooms

Abstract

Pharmacy technicians are exposed to volatile organic compounds, like the disinfectant isopropyl alcohol (IPA), during the process of aseptic compounding of parenteral cytotoxic drugs. The occupational exposure to nebulized IPA during aseptic compounding has not been investigated. The aim of this study was to investigate the exposure to IPA during aseptic compounding of parenteral cytotoxic drugs and to assess compliance with legal and regulatory limits. As a secondary endpoint, the difference between two disinfection methods was compared regarding the exposure to IPA. The exposure to IPA was measured during five working shifts of 8 hr and one shift of 4 hr. The concentration IPA was measured by using a six-gas monitor. Total daily exposure was calculated as 8-hr Time Weighted Average (TWA) air concentration in mg/m³ and compared with an Occupational Exposure Limit (OEL) value of 500 mg/m³ and incidental peak exposure of 5,000 mg/m³. To assess whether the 8-hr TWA air concentration meets the legal and regulatory limits the Similar Exposure Groups (SEG) compliance test was used. A paired sample t-test was conducted to assess difference in exposure between two disinfection methods. The average 8-hr TWA exposure to IPA during the six measurements varied from 2.6 mg/m³ to 43.9 mg/m³ and the highest momentary concentration measured was 860 mg/m³. The result of the SEG compliance test was 3.392 (U_r value) and was greater than the U_t value of 2.187 which means the exposure to IPA is in compliance with the OEL value. No significant difference in exposure was shown between two disinfection methods (p = 0.49). In conclusion, exposure to IPA during aseptic compounding of parenteral cytotoxic drugs showed compliance to the OEL values with no significant difference in exposure between two disinfection methods.

Keywords:

• Antineoplastic drugs
• nebulized
• occupational exposure limit
• volatile organic compounds

Acknowledgments

The authors are grateful to the pharmacy technicians for their time and support of the study and F.F. van den Berg for his contribution to drafting the figures.

Funding

Regular institutional funding.

Ethics approval

The pilot study was approved by the Medical Ethics Review Committee of VU University Medical Center (IRB00002991). The FWA number assigned to VU Medical Center is FWA00017598.