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<p>Bevacizumab, a cost-effective anti-VEGF agent widely repurposed for retinal diseases in resource-limited settings, is frequently compounded into multi-dose vials to offset the expense of approved alternatives. However, concerns persist regarding microbial contamination risks from repeated vial punctures, exacerbated by challenges such as inconsistent refrigeration, variable sterile technique adherence, and lack of preservatives. This prospective study assessed contamination rates in 28 repackaged bevacizumab vials stored at 4–8&#xa0;°C over six weeks in two Iraqi hospitals. Aseptic protocols included disinfection of vial stoppers with 70% alcohol, refrigeration compliance, and weekly equipment calibration. From each vial, 0.05 mL aliquots were sampled at weeks 1 and 6 and cultured in thioglycolate broth (aerobic/anaerobic) and Sabouraud dextrose broth (fungal) for 14 days. Negative controls (sterile saline) and positive controls (<i>Pseudomonas aeruginosa</i>, <i>Escherichia coli</i>, and <i>Candida albicans</i>) were included to validate assay sensitivity and specificity. Among 899 intravitreal injections administered, no microbial growth was detected in any aliquot, aligning with control-confirmed sterility. One case of sterile endophthalmitis (0.11%) resolved without sequelae, with no infectious cases observed during follow-up. These findings, consistent with prior studies demonstrating contamination-free multi-dose vials under strict protocols, underscore the viability of repackaged bevacizumab in low-resource settings when paired with rigorous aseptic practices, validated culture methods, and controlled storage.</p>

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Assessment of the Microbial Contamination Rate of Multi-puncture Vials of Bevacizumab and the Risk of Endophthalmitis

  • 期刊论文

  • 发表日期：

    2025年6月12日

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  • Maytham Hashim Neamah,
  • Hasan Abdulameer Al-Mu’mar

摘要

Bevacizumab, a cost-effective anti-VEGF agent widely repurposed for retinal diseases in resource-limited settings, is frequently compounded into multi-dose vials to offset the expense of approved alternatives. However, concerns persist regarding microbial contamination risks from repeated vial punctures, exacerbated by challenges such as inconsistent refrigeration, variable sterile technique adherence, and lack of preservatives. This prospective study assessed contamination rates in 28 repackaged bevacizumab vials stored at 4–8 °C over six weeks in two Iraqi hospitals. Aseptic protocols included disinfection of vial stoppers with 70% alcohol, refrigeration compliance, and weekly equipment calibration. From each vial, 0.05 mL aliquots were sampled at weeks 1 and 6 and cultured in thioglycolate broth (aerobic/anaerobic) and Sabouraud dextrose broth (fungal) for 14 days. Negative controls (sterile saline) and positive controls (Pseudomonas aeruginosa, Escherichia coli, and Candida albicans) were included to validate assay sensitivity and specificity. Among 899 intravitreal injections administered, no microbial growth was detected in any aliquot, aligning with control-confirmed sterility. One case of sterile endophthalmitis (0.11%) resolved without sequelae, with no infectious cases observed during follow-up. These findings, consistent with prior studies demonstrating contamination-free multi-dose vials under strict protocols, underscore the viability of repackaged bevacizumab in low-resource settings when paired with rigorous aseptic practices, validated culture methods, and controlled storage.