Microbial growth in vials of Botulinum toxin following use in clinic

Eye (Lond). 2007 Jul;21(7):995-7. doi: 10.1038/sj.eye.6702465. Epub 2006 Jun 2.

Abstract

Purpose: Botulinum toxin has various applications in ophthalmology and is used in the outpatient department, where it is often exposed to room temperatures for 3-4 h. The manufacturer's recommendations are that the reconstituted toxin be stored in a refrigerator when not in use and discarded 4 h after reconstitution. The aim of our study was to examine such used bottles of Botulinum toxin for microbial growth after 4 h at room temperature.

Methods and results: Eleven consecutive bottles of Botulinum toxin used with aseptic precautions in the Ophthalmology outpatient clinics were exposed to room temperatures for 4 h. These were subsequently analysed for microbial growth. No growth was directly obtained from any of the Botulinum toxin bottles during our study.

Conclusions: This pilot study suggests that if aseptic precautions are followed during the use of Botulinum toxin, the contents of the bottle remain sterile despite being exposed to room temperatures for up to 4 h. This has implications on the use of the reconstituted toxin after the recommended 4 h.

MeSH terms

  • Asepsis / methods
  • Bacteria / growth & development*
  • Bacteria / isolation & purification
  • Botulinum Toxins, Type A / standards*
  • Colony Count, Microbial
  • Drug Contamination*
  • Drug Storage / methods
  • England
  • Humans
  • Neuromuscular Agents / standards*
  • Ophthalmology / standards
  • Outpatient Clinics, Hospital / standards
  • Pilot Projects
  • Practice Guidelines as Topic
  • Refrigeration
  • Temperature
  • Time Factors

Substances

  • Neuromuscular Agents
  • Botulinum Toxins, Type A