{"id":2324,"date":"2018-06-05T14:19:45","date_gmt":"2018-06-05T05:19:45","guid":{"rendered":"https:\/\/www.hamarichemicals.com\/wp\/en\/?page_id=2324"},"modified":"2022-01-26T12:10:52","modified_gmt":"2022-01-26T03:10:52","slug":"high-potency-drug-substance-manufacture","status":"publish","type":"page","link":"https:\/\/www.hamarichemicals.com\/eng\/company\/production\/yonezawa\/high-potency-drug-substance-manufacture\/","title":{"rendered":"High Potency Drug Substance Manufacture Plant"},"content":{"rendered":"

 <\/p>\n

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Yonezawa Site’s High Potency Drug Substance Manufacture Plant<\/h1>\n
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 \u03bcg\/m3<\/sup>, 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.<\/div>\n<\/div>\n<\/div>\n

 
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Equipment Overview<\/h2>\n
<\/div>\n
\n
\n
\n
\n
Cleanliness Class<\/dt>\n
ISO7 \/ ISO8<\/dd>\n<\/dl>\n<\/div>\n
\n
\n
Primary Contain.<\/dt>\n
Hard isolator and flexible enclosure<\/dd>\n<\/dl>\n<\/div>\n
\n
\n
Secondary Contain.<\/dt>\n
Pressure controlled room, clothes entry\/exit separation, decontamination shower, HEPA-2, BIBO<\/dd>\n<\/dl>\n<\/div>\n
\n
\n
Exposure Mgmt.<\/dt>\n
OEL 1 to 10 \u03bcg\/m3<\/sup>, Category 4 (Pharma Solutions Co., Ltd.’s Classification)<\/dd>\n<\/dl>\n<\/div>\n
\n
\n
Batch Size<\/dt>\n
10 to 20 kg<\/dd>\n<\/dl>\n<\/div>\n
\n
\n
Production Line<\/dt>\n
1 line<\/dd>\n<\/dl>\n<\/div>\n
\n
\n
Manuf. Equipment<\/dt>\n
GL reactors (1200, 600, 500, 300 L), SUS centrifuge (300 L), SUS+PFA pressurized filter, Hastelloy filter-dryer, SUS pin-mill<\/dd>\n<\/dl>\n<\/div>\n<\/div>\n
\n
\n <\/p>\n
pin-mill<\/div>\n<\/p><\/div>\n
\n <\/p>\n
filter-dryer<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

  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 \u03bcg\/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 \u03bcg\/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<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":61,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"page-company.php","meta":{"footnotes":""},"class_list":["post-2324","page","type-page","status-publish","hentry"],"yoast_head":"\nHigh Potency Drug Substance Manufacture Plant - Hamari Chemicals, Ltd.<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hamarichemicals.com\/eng\/company\/production\/yonezawa\/high-potency-drug-substance-manufacture\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"High Potency Drug Substance Manufacture Plant - Hamari Chemicals, Ltd.\" \/>\n<meta property=\"og:description\" content=\"  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 \u03bcg\/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 \u03bcg\/m3, Category 4 (Pharma Solutions Co., Ltd.’s Classification) Batch Size 10 to 20 kg Production Line 1 line Manuf. 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