Standards for Medicament Factory Establishments Article 10

Factories that manufacture pharmaceutical suspensions, tinctures, extracts, fluid extracts or liquid preparations (including eye drops, hemodialysis solutions and lavage solutions) shall, as needed, install the following facilities:(1) Facilities for the manufacturing of distilled water distillation or purified water;(2) Liquid blending containers, settling tanks or ceramic vats;(3) Percolation facilities;(4) Soaking facilities;(5) Filtration facilities;(6) Stirring facilities;(7) Quantitative filling (packaging) and container sealing facilities;(8) Heat compression (pressure-reduction) facilities;(9) Sterilization facilities.Factories that manufacture eye drops 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10條
懸液劑、酊劑、浸膏劑、流浸膏劑、液劑(含眼用液劑、血液透析液、灌洗用液劑)藥品製造工廠,應視需要設置下列設備:
一、蒸餾水或純淨水之製造設備。
二、液劑調配容器或液劑澄清槽或瓷缸。
三、滲漉設備。
四、浸漬設備。
五、過濾設備。
六、攪拌設備。
七、定量充填(分裝)及容器封閉設備。
八、加熱濃縮(減壓)裝置。
九、滅菌設備。
眼用液劑製造工廠,另應視需要設置空氣潔淨、無菌充填(分裝)及無菌試驗設備。

English translation for reference only; the Chinese text prevails. Not legal advice.