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THOMAS H. CONNOR, PH.D., is Research Biologist, Division of Applied Research and Technology, National Institute for Occupational Safety and Health (NIOSH), Cincinnati, OH. PAUL J. M. SESSINK, PH.D., is President, Exposure Control B.V., Wijchen, The Netherlands. BRUCE R. HARRISON, M.S., BCOP, is Clinical Pharmacy Specialist, Section of Hematology/Oncology, Veterans Affairs Medical Center, St. Louis, MO. JACK R. PRETTY, PH.D., is Research Chemist, Division of Applied Research and Technology, NIOSH. BYRON G. PETERS, B.S., is Director of Pharmacy, Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis. RAUL M. ALFARO, M.S., is Research Chemist, Clinical Pharmacokinetics Research Laboratory, Pharmacy Department, Clinical Center, National Institutes of Health (NIH), Bethesda, MD. APPIE BILOS and GWENDOLYN BECKMANN are Laboratory Technicians, Research Laboratory Molecular Epidemiology, Department of Epidemiology and Biostatistics, University Medical Center Nijmegen, Nijmegen, The Netherlands. MICHAEL R. BING, B.S., is Oncology Pharmacist, St. Louis University Cancer Center, St. Louis. LAKISHA M. ANDERSON, B.S., is a student, Department of Environmental Health, University of Alabama at Birmingham. ROBERT DECHRISTOFORO, M.S., CAPT USPHS, is Deputy Chief, Pharmacy Department, Clinical Center, NIH.
Address correspondence to Dr. Connor, National Institute for Occupational Safety and Health, MS C-23, 4676 Columbia Parkway, Cincinnati, OH 45226 (tmc6{at}cdc.gov).
Summary. Study 1 evaluated the external contamination of drug vials with cyclophosphamide and ifosfamide in a pharmacy setting. Widespread contamination of the outside of drug vials was found with each drug. Study 2 evaluated the surface contamination of drug vials with cyclophosphamide and fluorouracil in three pharmacies. Sporadic contamination with fluorouracil was detected, while cyclophosphamide was found on most vials. In study 3, investigators compared the decontamination abilities of a standard decontamination procedure at the manufacturer level with an improved decontamination procedure and the use of sleeves to further decrease contamination. Though the methods of each study reported herein differed, the outcomes were similar. All chemotherapy drug vials studied demonstrated levels of contamination with the drug well above the limit of detection. Improved decontamination procedures, combined with the use of protective sleeves, reduced the level of platinum contamination by 90%, suggesting that standard decontamination procedures should be reconsidered.
Conclusion. The results of these studies are consistent with several others that have reported contamination of the outside surface of drug vials for a number of chemotherapy drugs. Contamination can be reduced by using decontamination equipment and protective sleeves during the manufacturing process.
Index terms: Antineoplastic agents; Cisplatin; Contamination; Cyclophosphamide; Decontamination; Fluorouracil; Ifosfamide; Injections; Manufacturing; Pharmacy; Vials
Purpose. The results of three studies that describe the external contamination of chemotherapy drug vials are presented. New techniques for the improved decontamination of vials containing cisplatin are also described.
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