生物製劑先導工廠建築規劃之研究

Architectural Planning for Biomedical Pharmaceutical Factory

喻文莉(Wen-Li Yu)

指導教授 ： 郭斯傑

國立臺灣大學/工學院/土木工程學研究所/碩士(2006年)

https://doi.org/10.6342/NTU.2006.10106

摘要

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法規規定，彙整建立「生物製劑先導工廠」人用疫苗產區對空間、環境、動線、空調、機電及儀器設備的要求及指導性規範，以說明安全設計之觀念及方法，利用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，進行規劃設計之基礎研究，為建築領域開啟新的研究議題，並藉由此研究作為未來規劃設計時的參考資料。
由於研究時間之限制，本研究範圍僅以規劃設計層面，深入分析「生物製劑先導工廠」之相關課題，主要分析內容包括「生物製劑先導工廠」之動線設計、隔間設計、空調設計、電力系統設計、警報及監控系統設計、給排水及污水系統設計、儀器設備等七大項目，並經由與各方面的專家學者深入探討後，除將法令規範作一整體性的彙整分析外，另針對「生物製劑先導工廠」實務規劃案例，進行：生物安全分區、清淨度區域、人流進出動線、器材(乾淨、污染)進出動線、製劑(細胞/細菌/病毒菌種、原物料、取樣、培養緩衝液、產品、注射瓶、中間產品)進出動線、廢棄物離開動線、壓力流向等七項規劃設計之基礎研究。
本研究亦針對國內已興建「生物製劑先導工廠」之規劃設計建立改進對策及建議，以改良現有「生物製劑先導工廠」規劃設計之不足，並作為日後規劃設計者之借鏡，其研究結果將有助於改善國內「生物製劑先導工廠」專業設計之不足，提升相關領域對「生物製劑先導工廠」建築之重視及建築設計之水準，並作為未來規劃設計相同性質建築物時之考量重點。

關鍵字

生物製劑先導工廠 ； 生物安全第三等級實驗室 ； cGMP

並列摘要

The subject of this study is「Biomedical Pharmaceutical Factory」which is categorized to high-danger character. In accordance with domestic and foreign related cGMP and Biological Safety Level III, its vaccine explains concept and methodology of safety design toward requirement and guidance of space, environment, circulation, air-conditioning, mechanical and electrical engineering and instrumental facilities. To utilize interview of specialist with fairly experience and to present its actual case, basic research of planning have been undertaken. In order to open a new theme for architectural domain, reference for coming planning is expected.
Due to time restriction, 「Biomedical Pharmaceutical Factory」 and related topic will be in-depth analyzed only with planning layer. The main analysis includes seven items of its planning of circulation, partition, air-conditioning, electricity system, alarm and monitor system, water supply/drainage and sewage system as well as instrumental facilities. Through discussing with experts and scholars in all aspects, besides the whole collection and analysis laws and norms, a practical planning to「Biomedical Pharmaceutical Factory」 has been undertaken. The basic study of seven planning are: creature safety area, peace and quiet, in- and out-circulation of personnel, circulation of material (clean, polluted), in- and out-circulation of pharmaceutical preparation (cell/germs/virus fungus, original material, sampling, cultivate buffer fluid, product, injection bottle, intermedium), the move-off circulation of discard, as well as pressure flow direction.
In the light of planning of「Biomedical Pharmaceutical Factory」, improvement and suggestion have been established in order to refine its current insufficient planning and reference afterward. The results will be helpful to improve its shortage of specialized planning, as well as to promote of attaching importance and planning level. Establishing of improvement to refine its current shortage of planning for afterward is also attempted by this study.

並列關鍵字

Biomedical Pharmaceutical Factory ； Laboratory of Biological Safety Level III ； cGMP

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