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Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: results of three studies.

Connor TH; Sessink PJM; Harrison BR; Pretty JR; Peters BG; Alfaro RM; Bilos A; Beckman G; Bing MR; Anderson LM; Dechristoforo R

Am J Health Syst Pharm 2005 Mar; 62(5):475-484

https://doi.org/10.1093/ajhp/62.5.475

20026412

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. 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. 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.

Pharmaceuticals; Pharmaceutical-industry; Drugs; Decontamination; Protective-clothing; Protective-equipment; Antineoplastic-agents; Author Keywords: Antineoplastic agents; Cisplatin; Contamination; Cyclophosphamide; Decontamination; Fluorouracil; Ifosfamide; Injections; Manufacturing; Pharmacy; Vials

Dr. Connor, National Institute for Occupational Safety and Health, MS C-23, 4676 Columbia Parkway, Cincinnati, OH 45226

AHSPEK

50-18-0; 15663-27-1

20050301

Journal Article

tmc6@cdc.gov

2005

5

1079-2082

DART

Research Tools and Approaches: Exposure Assessment Methods

American Journal of Health-System Pharmacy

OH; MO