Surface Contamination of Chemotherapy Drug Vials and Evaluation of New Vial-Cleaning Techniques: Results of Three Studies

Details

• Personal Author:
  Alfaro RM ; Anderson LM ; Beckman G ; Bilos A ; Bing MR ; Connor, Thomas H. ; Dechristoforo R ; Harrison BR ; Peters BG ; Pretty JR ; Sessink PJM
• Description:
  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. [Description provided by NIOSH]
• Subjects:
  Antineoplastic Agents Biopharmaceutics Manufacturing And Industrial Facilities Occupational Health Personal Protective Equipment Pharmacies Protective Clothing Safety
• Keywords:
  Antineoplastic-agents Author Keywords: Antineoplastic Agents Cisplatin Contamination Cyclophosphamide Decontamination Drugs Fluorouracil Ifosfamide Injections Manufacturing Pharmaceutical-industry Pharmaceuticals Pharmacy Protective-clothing Protective-equipment Vials

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• ISSN:
  1079-2082
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  Missouri ; Ohio ; OSHA Region 5 ; OSHA Region 7
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  DART - Division of Applied Research and Technology
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  475-484
• Volume:
  62
• Issue:
  5
• NIOSHTIC Number:
  nn:20026412
• Citation:
  Am J Health Syst Pharm 2005 Mar; 62(5):475-484
• Contact Point Address:
  Dr. Connor, National Institute for Occupational Safety and Health, MS C-23, 4676 Columbia Parkway, Cincinnati, OH 45226
• Email:
  tmc6@cdc.gov
• CAS Registry Number:
  Cisplatin (CAS RN 15663-27-1) ; Cyclophosphamide (CAS RN 50-18-0)
• Federal Fiscal Year:
  2005
• NORA Priority Area:
  Research Tools and Approaches: Exposure Assessment Methods
• Peer Reviewed:
  True
• Source Full Name:
  American Journal of Health-System Pharmacy
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:7561c1927f82f2106bb102111adb4536a0d1928f3327a04f503070057e926022b92f63007fd9134d2032e6b23a2d33fee1a1c0bd672fdd326948013dd8557394
• Download URL:
  https://stacks.cdc.gov/view/cdc/197269/cdc_197269_DS1.pdf
• File Type:
  [PDF - 122.19 KB ]