Standards for Medicament Factory Establishments Article 27
In factories that manufacture medical materials, operation areas shall be separated based on the type of material produced; they shall also, as needed, install the following facilities:(1) Cotton fluffing, spreading or carding machines; where these procedures are contracted out to other factories, installation of said facilities may be waived.(2) Pressure degreasing facilities;(3) Rinsing facilities;(4) Dehydration facilities;(5) Drying facilities (drying room);(6) Spinning machines, weaving machines and other textile facilities; where these procedures are contracted out to textile factories, installation of said facilities may be waived.(7) Gauze cutting facilities;(8) Bandage cutting facilities;(9) Appropriate facilities to prevent recontamination of gauze and bandages after drying;(10) Tape adhesive or medical material annealing facilities;(11) Soaking and blending facilities; to be installed at factories using the solvent method;(12) Coating facilities;(13) Drying and sterilizing facilities;(14) Ground fabric processing facilities;(15) Fabric cutting and rolling facilities;(16) Soaking and drying facilities for medicinal gauze;(17) Aseptic testing facilities for semi-finished and end products shall be installed as needed.The facilities mentioned in Subparagraph 1 through Subparagraph 5 of the preceding Paragraph are commonly used in the manufacturing of degreased cotton; the facilities mentioned in Subparagraph 2 through Subparagraph 8 are commonly used in the manufacturing of medicinal gauze and bandages; the facilities mentioned in Subparagraph 10 through Subparagraph 15 are commonly used in the manufacturing of adhesive tape; the facilities mentioned in Subparagraph 15 and Subparagraph 16 are commonly used in the manufacturing of first aid adhesive tape and medicinal gauze.
中文原文 藥物製造工廠設廠標準第27條
衛生材料類製造工廠，除各作業場所應視其性質予以區分隔離外，應視需要設置下列設備：
一、彈棉機、展棉機或梳棉機：委託整棉廠加工者，得免設置。
二、加壓脫脂設備。
三、漂洗設備。
四、脫水設備。
五、乾燥設備（乾燥室）。
六、紡紗機、織布機等紡織設備：委託棉織廠加工者，得免設置。
七、紗布裁切設備。
八、繃帶裁切設備。
九、敷料經乾燥後，應有適當防止再污染之設備。
十、絆創膏基劑或藥材料煉合設備。
十一、浸漬調合設備：係採用溶劑法者，應具有之設備。
十二、塗布設備。
十三、乾燥及滅菌設備。
十四、底布加工設備。
十五、裁切及捲布設備。
十六、藥用紗布浸漬乾燥設備。
十七、視需要設置半製品或最終產品之無菌檢查設備。
前項第一款至第五款，係製造藥用脫脂棉者常用之設備；第二款至第八款，係製造藥用紗布繃帶者常用之設備；第十款至第十五款，係製造絆創膏者常用之設備；第十五款及第十六款，係製造急救用絆創膏、藥用紗布者常用之設備。
一、彈棉機、展棉機或梳棉機：委託整棉廠加工者，得免設置。
二、加壓脫脂設備。
三、漂洗設備。
四、脫水設備。
五、乾燥設備（乾燥室）。
六、紡紗機、織布機等紡織設備：委託棉織廠加工者，得免設置。
七、紗布裁切設備。
八、繃帶裁切設備。
九、敷料經乾燥後，應有適當防止再污染之設備。
十、絆創膏基劑或藥材料煉合設備。
十一、浸漬調合設備：係採用溶劑法者，應具有之設備。
十二、塗布設備。
十三、乾燥及滅菌設備。
十四、底布加工設備。
十五、裁切及捲布設備。
十六、藥用紗布浸漬乾燥設備。
十七、視需要設置半製品或最終產品之無菌檢查設備。
前項第一款至第五款，係製造藥用脫脂棉者常用之設備；第二款至第八款，係製造藥用紗布繃帶者常用之設備；第十款至第十五款，係製造絆創膏者常用之設備；第十五款及第十六款，係製造急救用絆創膏、藥用紗布者常用之設備。