title: A strategy for reducing particulate contamination on opening glass ampoules and development of evaluation methods for its application.
abstract: A single-dose glass ampoule was developed for ease of administration. When glass ampoules are opened, resulting in contamination by particulate matter. Reducing its contamination may minimize the risk in patients due to particulates. This study reports on an attempt to reduce insoluble particulate contamination by developing methods for the precise measurement of this. A vacuum machine (VM) was used to reduce the level of insoluble particulate contamination, and a microscopy, scanning electron microscopy-energy dispersive X-ray spectrometer (SEM-EDS) and inductively coupled plasma-atomic emission spectrometer (ICP-AES) were used to evaluate the level of reduction. The method permitted the insoluble particle content to be reduced by up to 87.8 and 89.3% after opening 1 and 2 mL-ampoules, respectively. The morphology of the glass particulate contaminants was very sharp and rough, a condition that can be harmful to human health. The total weight of glass particles in the opened ampoules was determined to be 104 ± 72.9 μg and 30.5 ± 1.00 μg after opening 1 and 2 mL-ampoules when the VM was operated at highest power. The total weights were reduced to 53.6 and 50.6%, respectively for 1 and 2 mL-ampoules, compared to opening by hand. The loss of ampoule contents on opening by the VM was 6.50 and 4.67% for 1 and 2 mL-ampoules, respectively. As a result, the VM efficiently reduced glass particulate contamination and the evaluation methods used were appropriate for quantifying these levels of contamination.
authors.affiliation: Department of Pharmaceutics, College of Pharmacy, Seoul National University, Gwanak-gu, Seoul, South Korea.
authors.forename: Kyeong-Ryoon
authors.initials: KR
authors.lastname: Lee
authors.forename: Yoon-Jee
authors.initials: YJ
authors.lastname: Chae
authors.forename: Sung-Eel
authors.initials: SE
authors.lastname: Cho
authors.forename: Suk-Jae
authors.initials: SJ
authors.lastname: Chung
mesh_terms: D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging / Q000379:methods* / Q000592:standards; D005898:Glass; D006801:Humans; D007267:Injections; D008855:Microscopy, Electron, Scanning / Q000379:methods; D010316:Particle Size; D019999:Pharmaceutical Solutions; D013052:Spectrometry, X-Ray Emission / Q000379:methods; D013054:Spectrophotometry, Atomic / Q000379:methods
chemical_list: D019999:Pharmaceutical Solutions