Yonezawa Site’s High Potency Drug Substance Manufacture Plant

HAMARI PFST, Ltd.’s Yonezawa Site has a dedicated high potency drug substance manufacture facility built in March 2019. The facility manages substances with OEL 1 to 10 μg/m3, Category 4 (Pharma Solutions Co., Ltd.’s Classification) and suitable for injection grade APIs. The HAMARI Group is expanding its manufacture capabilities to cover highly potent drug substances and provide a comprehensive production system.

 
 
 

Equipment Overview

Cleanliness Class
ISO7 / ISO8
Primary Contain.
Hard isolator and flexible enclosure
Secondary Contain.
Pressure controlled room, clothes entry/exit separation, decontamination shower, HEPA-2, BIBO
Exposure Mgmt.
OEL 1 to 10 μg/m3, Category 4 (Pharma Solutions Co., Ltd.’s Classification)
Batch Size
10 to 20 kg
Production Line
1 line
Manuf. Equipment
GL reactors (1200, 600, 500, 300 L), SUS centrifuge (300 L), SUS+PFA pressurized filter, Hastelloy filter-dryer, SUS pin-mill

pin-mill

filter-dryer