Yonezawa Hamari’s High Potency Drug Substance Manufacture Facility

A dedicated facility to manufacture high potency drug substances is being constructed!!
Yonezawa Hamari has started construction for a dedicated high potency drug substance manufacture facility which will be operation in April 2019. The facility will manage substances with OEL 1 to 10 μg/m3, Category 4 (Pharma Solutions Co., Ltd.’s Classification) and will also manufacture injection grade APIs. The Hamari Group is expanding its manufacture capabilities to cover highly potent drug substances and provide a comprehensive production system.

 
 
 

Construction Outline

Manuf. Equipment
GL reaction, press filter, centrifugal separator, filter dryer, milling machine
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