Standards for Medicament Factory Establishments Article 30

Factories that manufacture blood collection and blood transfusion devices (that incorporate plastic tubes) shall, as needed, install the following facilities:(1) High-speed stirring facilities;(2) Stir cooling facilities;(3) Plastic pellet facilities;(4) High-pressure steam sterilization facilities;(5) High-frequency welding facilities;(6) Water sterilization facilities;(7) Aseptic operation rooms.
中文原文 藥物製造工廠設廠標準第30條
採血及輸血用器具類(使用塑膠管)製造工廠,應視需要設置下列設備:
一、高速攪拌設備。
二、冷卻攪拌設備。
三、膠粒設備。
四、高壓蒸氣滅菌設備。
五、高週波熔接設備。
六、製造無菌水裝置。
七、無菌操作室。

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