Standards for Medicament Factory Establishments Article 18
Factories that manufacture biopharmaceuticals or biotechnology products shall have operation areas with interior ceilings, walls, doors, floors and other structural components that are easily cleaned and disinfected; and shall also, as needed, install the following facilities:(1) Facilities for the breeding and segregation of animals used in manufacturing and testing, and animals that have been inoculated with microorganisms;(2) Areas, facilities and equipment for safety testing and bioassaying;(3) Factories that collect animal blood or use other animal products in the manufacturing of vaccines shall possess water sources and facilities sufficient for required rinsing.(4) Waste water removal and disinfection facilities shall be installed in the operation areas.(5) Microorganism culturing facilities;(6) Microorganism filtering facilities;(7) Microorganism inoculation and collection facilities;(8) Freeze-drying facilities;(9) Dilution facilities;(10) Filling (packaging) and container sealing facilities;(11) Microorganism storage facilities;(12) Intermediate and end product storage facilities; said facilities should be kept at temperatures appropriate to each type of product stored.(13) Blending solution and culture medium production facilities;(14) Pre-use and post-use sterilization and disinfection facilities for containers, solutions and culture mediums used in manufacturing and testing;(15) Thermostats, sterilization facilities, refrigeration and freezing facilities, automatic regulators, thermometers and necessary recording instruments;(16) Facilities for the incineration or destruction of animal remains and other waste materials;(17) Employees’ changing and bathing facilities;(18) Animal dissection and organ grinding facilities;(19) Other relevant facilities.Areas where spores, bacteria or viruses are handled shall be completely separated from other areas.Areas with the facilities mentioned in Subparagraph 7 through Subparagraph 10 of Paragraph 1 shall be aseptic facilities, and shall be equipped with necessary aseptic air conditioners. Areas with the facilities mentioned in Subparagraph 10 of Paragraph 1 shall be aseptic air conditioners with dehumidifying capabilities.
中文原文 藥物製造工廠設廠標準第18條
生物藥品或生物技術產品製造工廠，除作業場所之室內天花板、牆壁、門窗、地面等之構造設備，應便於洗滌及消毒外，應視需要設置下列設備：
一、製造、試驗用動物及接種微生物後之動物飼養隔離設備。
二、安全試驗與生物檢定場所、設施及設備。
三、動物採血及動物來源製造痘苗之製造廠，應有足夠沖洗之水源設備。
四、作業場所應有清理污水及消毒設備。
五、微生物培養設備。
六、微生物過濾設備。
七、微生物接種及採取設備。
八、冷凍乾燥設備。
九、稀釋原液調製設備。
十、充填（分裝）及容器密封設備。
十一、微生物之貯藏設備。
十二、製造過程中之中間產品及最終產品之貯藏設備：貯藏設備之室溫，應適合各貯藏產品之溫度。
十三、調劑用溶液及培養基調製設備。
十四、使用前、後之製造與檢驗用之器具及各種溶液、培養基等之滅菌消毒設備。
十五、恒溫器、滅菌設備、冷藏及冷凍設備，並附裝自動調節器、溫度計及其他必要之紀錄儀器。
十六、動物屍體及其他污物焚化或銷毀設備。
十七、員工更衣及沐浴設備。
十八、動物解剖及臟器磨碎設備。
十九、其他相關設備。
操作芽孢、細菌及病毒場所，應與其他場所完全隔離。
第一項第七款至第十款所定設備之場所，須係無菌室設備，並應裝設所需之無菌空氣調節器。
第一項第十款設備之場所應裝設之無菌空氣調節器，須係無菌減濕空氣調節器。
一、製造、試驗用動物及接種微生物後之動物飼養隔離設備。
二、安全試驗與生物檢定場所、設施及設備。
三、動物採血及動物來源製造痘苗之製造廠，應有足夠沖洗之水源設備。
四、作業場所應有清理污水及消毒設備。
五、微生物培養設備。
六、微生物過濾設備。
七、微生物接種及採取設備。
八、冷凍乾燥設備。
九、稀釋原液調製設備。
十、充填（分裝）及容器密封設備。
十一、微生物之貯藏設備。
十二、製造過程中之中間產品及最終產品之貯藏設備：貯藏設備之室溫，應適合各貯藏產品之溫度。
十三、調劑用溶液及培養基調製設備。
十四、使用前、後之製造與檢驗用之器具及各種溶液、培養基等之滅菌消毒設備。
十五、恒溫器、滅菌設備、冷藏及冷凍設備，並附裝自動調節器、溫度計及其他必要之紀錄儀器。
十六、動物屍體及其他污物焚化或銷毀設備。
十七、員工更衣及沐浴設備。
十八、動物解剖及臟器磨碎設備。
十九、其他相關設備。
操作芽孢、細菌及病毒場所，應與其他場所完全隔離。
第一項第七款至第十款所定設備之場所，須係無菌室設備，並應裝設所需之無菌空氣調節器。
第一項第十款設備之場所應裝設之無菌空氣調節器，須係無菌減濕空氣調節器。