著者

新井 進 竹本 正 水谷 正海 征矢 隆

出版者

The Surface Finishing Society of Japan

雑誌

表面技術 (ISSN:09151869)

巻号頁・発行日

vol.44, no.1, pp.50-54, 1993-01-01 (Released:2009-10-30)

参考文献数

16

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It is known that oxides of copper, nickel, tin, etc. are reduced in hydrogen atmosphere at soldering temperature. In expectation of this hydrogen reduction effect, dull nickel electrodeposits were formed under excess current density to obtain nickel films containing hydrogen and their solderability was measured by meniscograph. The hydrogen content of the nickel electrodeposits, and their crystal structure, composition and morphology were analyzed and correlations between these parameters and solderability investigated.The results are summarized as follows.(1) Nickel electrodeposits formed under excess current density showed a marked improvement in solderability.(2) The crystal structure of the nickel electrodeposits was fcc and the preferential orientation changed with current density, but no correlation was found between solderability and orientation.(3) There was good correlation between the solderability of the nickel electrodeposits and their hydrogen content.

著者

新井 進

出版者

The Surface Finishing Society of Japan

雑誌

表面技術 (ISSN:09151869)

巻号頁・発行日

vol.43, no.11, pp.1079-1080, 1992-11-01 (Released:2009-10-30)

参考文献数

9

被引用文献数

4 1

著者

新井 進

出版者

一般社団法人 表面技術協会

雑誌

表面技術 (ISSN:09151869)

巻号頁・発行日

vol.66, no.6, pp.252-255, 2015-06-01 (Released:2016-06-01)

参考文献数

46

著者

石井 明子 橋井 則貴 松本 真理子 香取 典子 新井 進 粟津 洋寿 磯野 哲也 井上 友美 永座 明 大山 幸仁 奥村 剛宏 梶原 大介 田熊 晋也 丹下 浩一 塚原 正義 筒井 麻衣子 寺島 伊予 中川 泰志郎 服部 秀志 林 慎介 原 芳明 松田 博行 村上 聖 矢野 高広 巌倉 正寛 大政 健史 川崎 ナナ 広瀬 明彦

出版者

一般社団法人日本PDA製薬学会

雑誌

日本PDA学術誌 GMPとバリデーション (ISSN:13444891)

巻号頁・発行日

vol.19, no.2, pp.15-29, 2017 (Released:2017-12-21)

参考文献数

17

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The use of single-use systems has been getting more popular in biologics manufacturing. Utilization of this novel technology enables the efficient manufacturing, including prevention of cross contamination, flexibility to manufacture multiple products, and elimination of the need for cleaning and steam sterilization including those validations. In order to ensure the quality and stable supply of biologics, appropriate risk management considering the characteristics of the system is necessary. However, there is no regulatory document describing the examples or recommendations on it. In 2015, we published the White paper of “Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics” in AAPS PharmSciTech, which was a fruit of discussion in the research group consisting of Japanese pharmaceutical manufacturers, single-use suppliers, academia and regulatory agencies. This review introduces the contents of the White paper with some revision reflecting the comments on it as well as the discussion in our research group after publishing the paper. The basic concept is consistent with ICH guideline on quality risk management. Here we describe the points to consider in risk assessment as well as in risk control when single-use systems are used in biologics manufacturing.