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The safety of multi-dose vials in allergy immunotherapy

Sandra Y Lin1, P Chase Lay, Larry F Hughes

  • 1Department of Otolaryngology, Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA. Slin30@jhmi.edu

Otolaryngology--Head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery
|July 29, 2008
PubMed
Abstract

Insights

Immunotherapy vials used in routine clinical practice demonstrated a low risk of bacterial contamination. Maintaining aseptic technique, utilizing bacteriostatic agents, and adhering to expiration dates are crucial for vial safety.

Area of Science:

  • Allergy and Immunology
  • Microbiology
  • Infectious Disease

Background:

  • Multiple-dose vials are commonly used for immunotherapy administration in clinical settings.
  • Ensuring the sterility of these vials is critical to prevent patient infections.

Purpose of the Study:

  • To prospectively assess the risk of microbial contamination in multiple-dose immunotherapy vials during routine clinical use.

Main Methods:

  • A prospective observational study was conducted over an 8-month period.
  • 136 multiple-dose immunotherapy vials were cultured for aerobic and anaerobic bacteria.
  • Cultures were performed at the 3-month expiration date after regular outpatient use.

Main Results:

  • All 136 cultured immunotherapy vials showed negative results for bacterial contamination.
  • No evidence of microbial growth was detected in vials used for injection immunotherapy.

Conclusions:

  • Routine clinical use of immunotherapy vials presents a low risk of contamination.
  • Key factors contributing to vial safety include strict aseptic technique, the presence of bacteriostatic agents, and adherence to expiration dating.

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