Makoto Sadamitsu

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Makoto Sadamitsu is principal scientist of Biologics & New Modalities Development, Pharmaceutical Sciences at Takeda Pharmaceutical Company Limited.

Articles

Using Process Capability for Statistical Evaluation of Cleaning Processes

Tomohiro Doi;Kosuke Takenaka;Takashi Kaminagayoshi;Shunsuke Omori;Makoto Sadamitsu;Yoshiaki Miko;Osamu Shirokizawa

June 7th 2018

This study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.

The Statistical Evaluation of Cleaning Processes Using Process Capability and its Application to New Product Introduction

Tomohiro Doi;Kosuke Takenaka;Takashi Kaminagayoshi;Shunsuke Omori;Makoto Sadamitsu;Yoshiaki Miko;Osamu Shirokizawa

May 2nd 2018

The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.