Standards for Medicament Factory Establishments Article 12
Factories that manufacture pharmaceutical ointments (including eye ointments) or suppositories shall, as needed, install the following facilities:(1) Powder grinding facilities;(2) Screening facilities;(3) Heating vat;(4) Blending facilities;(5) Filling (packaging) facilities;(6) Ointment tube sealing facilities;(7) Suppository molding facilities;(8) Sterilization, air purification, aseptic filling (packaging) and sterility test facilities;(9) Dust collection facilities.For factories that do not make use of ointment tubes, the installation of facilities mentioned in Subparagraph 5 and Subparagraph 6 of the preceding Paragraph may be waived.Factories that manufacture eye ointments shall, as needed, install the other following facilities: air clean, aseptic filling (packaging), and sterility test facilities.
中文原文 藥物製造工廠設廠標準第12條
軟膏（含眼用軟膏）、栓劑藥品製造工廠，應視需要設置下列設備：
一、粉末研磨設備。
二、篩粉設備。
三、加熱釜。
四、調勻設備。
五、充填（分裝）設備。
六、軟膏管封閉設備。
七、栓劑模型冷凝設備。
八、滅菌設備。
九、粉塵收集設備。
前項第五款及第六款所定之設備，於不裝軟膏管之工廠，得免設置。
眼用軟膏製造工廠，另應視需要設置空氣潔淨、無菌充填（分裝）及無菌試驗設備。
一、粉末研磨設備。
二、篩粉設備。
三、加熱釜。
四、調勻設備。
五、充填（分裝）設備。
六、軟膏管封閉設備。
七、栓劑模型冷凝設備。
八、滅菌設備。
九、粉塵收集設備。
前項第五款及第六款所定之設備，於不裝軟膏管之工廠，得免設置。
眼用軟膏製造工廠，另應視需要設置空氣潔淨、無菌充填（分裝）及無菌試驗設備。