2019.04.26
Akira Horinouchi(Director , Legal Affairs and Facility Management Department), who is in charge of PDE and exposure control level setting in our company, co-authored a paper on PDE setting as follows.
Title: Establishing daily exposure tolerances (PDEs) for cross-contamination risk assessment in pharmaceutical manufacturing
Journal: PHARM TECH JAPAN, Vol35, No3(2019), p.p.109-116.
Authors: Hasegawa, T. (Ono Pharmaceutical Co., Ltd.), Matsunaga, S. (Takeda Pharmaceutical Co., Ltd.), Yamaura, Y. (Asahi Kasei Finechem Co., Ltd.), Kato, N. (Chugai Pharmaceutical Co., Ltd.), Tsuneari, I. (Safety Evaluation Forum, Horinouchi, A. (SPERA PHARMA Co., Ltd.), Suzuki, M. (Kyowa Hakko Kirin Co., Ltd.), Mogi, H. (Santen Pharmaceutical Co., Ltd.)
SPERA PHARMA participates in the PDE (Permissible Daily Exposure Level) Study Group. We strive to manage the risk of cross and establishes PDE and exposure control levels in accordance with various guidelines in order to manage the risk of cross-contamination and ensure the safety of workers for pharmaceutical products that are manufactured or analyzed on contract. SPERA PHARMA participates in the PDE (Permissible Daily Exposure Level) Study Group. We strive to manage the risk of cross-contamination and ensure the safety of our workers by setting PDE and exposure control levels in a way that complies with various guidelines for contract manufacturing and analysis of pharmaceuticals.
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