Standards for Medicament Factory Establishments Article 17
Factories that manufacture antibiotics shall, as needed, install the following facilities:1. For injectable antibiotics(1) For liquid form antibiotics, the facilities mentioned in preceding one article shall be installed; for power form antibiotics, relevant facilities in Article 16 shall be installed in accordance with actual needs, and aseptic filling (packaging) facilities with appropriate temperature and humidity control capabilities, and automatic or semi-automatic precision scales shall also be installed additionally.(2) Doors/windows that open to the exterior shall be double doors/windows that seal tightly.(3) There shall be potency and safety testing facilities for antibiotic raw materials and products.(4) Preparation rooms (for drying, sterilization and storage of packaging materials and containers, and other preparatory tasks related to packaging) and packaging rooms (with appropriate temperature and humidity control capabilities, and automatic or semi-automatic precision scales) shall be installed in processing and packaging areas.2. For non-injectable antibiotics (including capsules, tablets, liquids, ointments, etc.): The various types of facilities described in the rules governing each dosage form shall be installed; in processing and packaging areas, air clean and sterilization equipment, and equipment for the regulation of temperature and humidity, shall be installed in accordance with actual needs; furthermore, the facilities mentioned in Item 2 and Item 3 of the preceding Subparagraph shall also be installed.3. Manufacturing, processing, re-packaging, packaging and other operation areas used in the manufacturing of penicillin products shall be located in a completely separate building; the air processing system for this building shall be independent from the systems of other drug production areas.
中文原文 藥物製造工廠設廠標準第17條
抗生素藥品製劑工廠，應視需要設置下列設備：
一、注射用抗生素製劑：
（一）液狀抗生素製劑，應具前條所列設備；粉狀抗生素製劑，除視其實際需要設置前條所列有關設備外，並應增加設置適當控制溫度與濕度之無菌充填（分裝）設備及自動或半自動精密天秤。
（二）通於室外之門窗，應設置能嚴密關閉之雙重門窗。
（三）應具備抗生素原料及產品之力價與安全試驗設備。
（四）加工分裝場所，應設置預備室（供分裝材料及容器之乾燥滅菌與儲藏及從事其他分裝準備工作之用）及分裝室（應設置適當控制濕度之無菌設備及自動或半自動精密天秤）。
二、非注射用抗生素製劑（如膠囊劑、錠劑、液劑、軟膏等）：除應比照各該製劑規定之各項設備外，其加工分裝場所，應視實際需要設置空氣潔淨、滅菌、溫度及濕度調節等設備，並應具備前款第二目及第三目所定之設備。
三、青黴素類藥品之製造、加工、分裝、包裝及其他作業場所，應有完全隔開之廠房，其空氣處理系統並應與其他藥品之系統各自獨立。
一、注射用抗生素製劑：
（一）液狀抗生素製劑，應具前條所列設備；粉狀抗生素製劑，除視其實際需要設置前條所列有關設備外，並應增加設置適當控制溫度與濕度之無菌充填（分裝）設備及自動或半自動精密天秤。
（二）通於室外之門窗，應設置能嚴密關閉之雙重門窗。
（三）應具備抗生素原料及產品之力價與安全試驗設備。
（四）加工分裝場所，應設置預備室（供分裝材料及容器之乾燥滅菌與儲藏及從事其他分裝準備工作之用）及分裝室（應設置適當控制濕度之無菌設備及自動或半自動精密天秤）。
二、非注射用抗生素製劑（如膠囊劑、錠劑、液劑、軟膏等）：除應比照各該製劑規定之各項設備外，其加工分裝場所，應視實際需要設置空氣潔淨、滅菌、溫度及濕度調節等設備，並應具備前款第二目及第三目所定之設備。
三、青黴素類藥品之製造、加工、分裝、包裝及其他作業場所，應有完全隔開之廠房，其空氣處理系統並應與其他藥品之系統各自獨立。