title: Establishment of powder dustiness evaluation method by dustmeter with small amount of pharmaceutical ingredients.
abstract: The ratio of high potent materials in the new chemical entities has recently increased in the pharmaceutical industry. Generally, most of them are highly hazardous, but there is little toxicity information about the active pharmaceutical ingredients in the early development period. Even if their handling amount is quite small, the dustiness of high potent powder generated in the manufacturing process has an important impact on worker health; thus, it is important to understand the powder dustiness. The purpose of this study was to establish a method to evaluate the powder dustiness by the consumption of small amount of samples. The optimized measurement conditions for a commercially available dustmeter were confirmed using lactose monohydrate and naproxen sodium. The optimized test conditions were determined: the dustmeter mode, the flow rate, the drum rotation speed, the total measurement time, and sample loaded weight were type I mode, 4 L/min, 10 rpm, 1 min and 1-10 g , respectively. The setup conditions of the dustmeter are considerably valuable to pharmaceutical industries, especially, at the early development stage and especially for expensive materials, because the amount of air-borne dust can be evaluated with accuracy by the consumption of small amount of samples.
authors.affiliation: Production Engineering Department, Chugai Pharmaceutical Co. Ltd., 5-5-1 Ukima Kita-ku, Tokyo 115-8543, Japan. Electronic address: ohtatma@chugai-pharm.co.jp.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Ohta
authors.affiliation: Production Engineering Department, Chugai Pharmaceutical Co. Ltd., 5-5-1 Ukima Kita-ku, Tokyo 115-8543, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Maeda
authors.affiliation: Production Engineering Department, Chugai Pharmaceutical Co. Ltd., 5-5-1 Ukima Kita-ku, Tokyo 115-8543, Japan.
authors.forename: Ryuji
authors.initials: R
authors.lastname: Kubota
authors.affiliation: Production Engineering Department, Chugai Pharmaceutical Co. Ltd., 5-5-1 Ukima Kita-ku, Tokyo 115-8543, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Koga
authors.affiliation: Faculty of Pharmaceutical Science, Toho University, 2-2-1 Miyama Funabashi, Chiba 274-8510, Japan.
authors.forename: Katsuhide
authors.initials: K
authors.lastname: Terada
mesh_terms: D004391:Dust / Q000032:analysis*; D007785:Lactose / Q000737:chemistry; D009288:Naproxen / Q000737:chemistry; D010316:Particle Size; D011208:Powders / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*
chemical_list: D004391:Dust; D011208:Powders; D009288:Naproxen; D007785:Lactose
keywords: Dustmeter; Heubach; High potent material; Powder dustiness