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A study on the contamination of injection bevacizumab on storage of multidose vials

Ketan Saoji1, Hemant Trehan1, Raja Narayanan1

  • 1Department of Ophthalmology, INHS Asvini, Mumbai, Maharashtra, India.

Indian Journal of Ophthalmology
|January 31, 2018
PubMed
Abstract

Insights

Bevacizumab vials can be safely stored and reused for one week after multiple punctures, showing no contamination. This finding suggests insignificant contamination rates for bevacizumab vials stored in a refrigerator.

Area of Science:

  • Microbiology
  • Oncology
  • Ophthalmology

Background:

  • Bevacizumab is an anti-VEGF monoclonal antibody used in oncology and ophthalmology.
  • The safety of storing and reusing bevacizumab vials after multiple punctures is a critical concern for clinical practice.

Purpose of the Study:

  • To determine the safety of storing and reusing bevacizumab vials for up to one week with multiple punctures.
  • To assess the microbiological contamination risk associated with such practices.

Main Methods:

  • An experimental microbiological study was conducted using bevacizumab vials after patient injections.
  • Vials were stored and sampled to mimic clinical reuse, with contamination assessed via microbial culture.
  • Positive and negative controls were used, and statistical analysis calculated the probability of contamination by chance.

Main Results:

  • A total of 210 samples from 30 bevacizumab vials were tested.
  • No microbial growth was observed in any of the bevacizumab samples.
  • The probability of achieving 210 sterile samples purely by chance was extremely low (<5.547 × 10-6).

Conclusions:

  • Bevacizumab vials showed no contamination after 7 days of storage in a standard refrigerator.
  • The rate of contamination for bevacizumab vials stored for 7 days is likely insignificant.
  • Further studies are recommended to validate these findings using the same protocol.

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