生物製劑先導工廠製程空間建築規劃之研究

A Study of Architectural Planning on Production Space of Biologic Pharmaceutical Pilot Factory

本研究以屬高危險性質之「生物製劑先導工廠」為研究對象，依國內外相關cGMP 及生物安全第三等級實驗室1 法規規定，將空間環境及硬體設備之需求，整合為動線(含空間)、隔間、空調、電力、警報及監控、給排水及污水、儀器設備等七項指導性規範及設計要求；進而分析「人用疫苗2 製程空間」案例內之生物安全分區、清淨度3 區域、人流進出動線、器材(乾淨、污染)進出動線、製劑(培養緩衝液、產品)進出動線、廢棄物離開動線、壓力流向等七項目，以提供檢討與改進建議。本研究除闡述說明安全設計之觀念及方法外，並配合具相當經驗之專家訪談加上國內目前「生物製劑先導工廠」實務規劃案例，其研究成果將有助國內政府單位及醫療產業在面對大型傳染性疾病侵襲而來的同時，快速建立一符合生物安全高標準之「生物製劑先導工廠」，以提供防疫所需的生物製劑；且一旦爆發人傳人流感疫情時，也能在最短時間內，量產所需的抗毒藥物與疫苗以抑制疫情的擴散。

This study takes the highly dangerous 'Biological Pharmaceutical Pilot Factory' as the research object, and in accordance with domestic and foreign regulations on cGMP and Biosafety Level 3 Laboratory, space environment and hardware equipment are integrated into seven guiding regulations and design requirements that include moving paths (including spaces), compartment, air conditioning, electrical power, alarm and surveillance, water supply and sewage, and equipment; and further analyzed is the case study of 'human vaccine production space' that has seven categories of biosafety zoning, cleanliness areas, human flow moving paths, equipments (clean and contaminated) in-out moving paths, pharmaceutical agents (cultivation of buffer solution and products) moving paths, disposed wastes retreat paths, and pressure flow, to provide recommendations for reviews and improvement. This study elaborates the concept and methods of the safety design, and based on interviews with highly experienced experts as well as case studies of domestic 'Biological Pharmaceutical Pilot Factory', the results of this research can help the government and the medical industry, in the face of large-scale invasion of infectious diseases, rapidly establish a 'Biological Pharmaceutical Pilot Factory' of high biosafety standard, to provide the needed biological agents for disease prevention; and once a human transmitted influenza or epidemic breaks out, massive production of anti-virus drugs and vaccines can be undertaken in the shortest possible time to inhibit the spread of the epidemic.