[Particulate contamination associated with the manipulation of drugs in glass ampules: A literature review]

Abstract

Objectives: The manipulation of drugs from glass ampules can generate particles when the ampule is broken. Several authors recommend the use of filter needle to withdraw the drug content. The aim of this study is to make an assessment of the presence of particles during the manipulation of glass ampules and to discuss the current practices.

Methods: Literature review based on a search strategy (Pubmed, Google Scholar) and a summary table of available data. Analysis to evaluate the efficacy of the filtration when data are available.

Results: Eighteen articles have been included. Most of study shows the presence of particles in glass ampules. Important discrepancies reported regarding the number of particles per ampule. Analysis of data from seven studies: decrease of 83% of the total number of particles (>10μm) identified when drugs are removed with filter needle. All studies but two confirm the efficacy of filter needles.

Conclusions: Studies show the presence of particles when drugs are removed from glass ampules. They do not allow to make a conclusion on human clinical consequences associated with the presence of particles. It is necessary to evaluate in human the risks associated with particle contamination to determine the optimal use of filter needle.

Keywords: Aiguille filtrante; Ampoule de verre; Contamination particulaire; Filter needle; Glass ampules; Particulate contamination.