Architectural Planning for Biomedical Pharmaceutical 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。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.第一章 緒論 1 1.1 研究動機 1 1.2 研究目的 2 1.3 研究範圍 2 1.4 研究方法 3 1.5 研究流程 4 1.6 各章節簡介 5 第二章 文獻回顧 6 2.1 生物安全等級實驗室(Biological Safety Level,BSL) 6 2.1.1 生物安全之定義與分級 6 2.1.2 生物實驗室種類 9 2.1.3 實驗室特殊設備－生物安全操作櫃 12 2.2 生物製劑工廠 18 2.2.1 生物製劑的法源及定義 18 2.2.2 生物製劑的種類 19 2.2.3 生物製劑製程原理 20 2.3 無塵室 24 2.3.1 無塵室定義與分級 24 2.3.2 無塵室空調特性 25 第三章 法令規範彙整分析與專家訪談 29 3.1 法令規範彙整分析 29 3.1.1 「生物製劑先導工廠」動線設計 (包含空間規劃) 29 3.1.2 「生物製劑先導工廠」隔間設計 31 3.1.3 「生物製劑先導工廠」空調系統設計 33 3.1.4 「生物製劑先導工廠」電力系統設計 35 3.1.5 「生物製劑先導工廠」警報及監控系統設計 36 3.1.6 「生物製劑先導工廠」給排水、污水系統設計 33 3.1.7 「生物製劑先導工廠」儀器設備選用 38 3.2 專家訪談 39 3.2.1 專家訪談目的 39 3.2.2 專家訪談對象 39 3.2.3 專家訪談－相關問題之研擬 40 3.2.4 專家訪談－解決對策之研擬 40 第四章 實證推演—案例研究 45 4.1 平面規劃研究 45 4.1.1 生物安全分區說明 46 4.1.2 清淨度區域說明 48 4.1.3 人流動線說明 49 4.1.4 器材動線說明 51 4.1.5 製劑動線說明 53 4.1.6 廢棄物動線說明 55 4.1.7 壓力流向說明 57 4.1.8 小結 60 4.2 平面設計之檢討與改進對策研擬 61 4.2.1 案例A－改進對策研擬 61 4.2.2 案例B－改進對策研擬 68 4.2.3 小結 74 第五章 結論及建議 76 5.1 結論 76 5.2 建議事項 77 5.3 後續研究 77 參考文獻 7

胡杨树轮δ13C记录的艾比湖地区夏季最高温度变化/Maximum Summer Temperature Reflected by δ13C of Populus Euphratica in Aibi Lake Region[J]

艾比湖是新疆北部生态环境最为敏感和脆弱的地区,这里分布的大片长龄胡杨是过去气候变化良好的记录体.本文利用艾比湖东岸的胡杨树轮资料,分析其宽度和稳定碳同位素组成,建立了树轮宽度年表和δ13C序列,并对δ13C序列进行了校正处理.树轮参数的气候意义分析表明胡杨树轮宽度所含的气候信息较少,而树轮δ13C校正序列与精河夏季高温显著负相关,为荒漠平原区树轮气候研究提供了新的资料.研究区夏季的高温超过了光合作用的适宜温度,降低光合作用速率(A),而地下水埋深较浅,叶片气候导度(g)并没有因受到水分条件限制而减小,在以上两个因素的共同作用下,叶片内部二氧化碳浓度(Ci)升高,导致胡杨δ13C与夏季高温负相关关系.建立了胡杨树轮δ13C校正序列与精河夏季高温的转换方程,方差解释量为33.0％.重建的精河145 a来夏季高温序列反映了这一地区气候变暖的趋势,其升温的幅度高于北半球夏季升温幅度,但二者冷暖阶段变化并不完全一致

JUNO Sensitivity on Proton Decay p→νˉK+p\to \bar\nu K^+ Searches

The Jiangmen Underground Neutrino Observatory (JUNO) is a large liquid scintillator detector designed to explore many topics in fundamental physics. In this paper, the potential on searching for proton decay in $p\to \bar\nu K^+$ mode with JUNO is investigated.The kaon and its decay particles feature a clear three-fold coincidence signature that results in a high efficiency for identification. Moreover, the excellent energy resolution of JUNO permits to suppress the sizable background caused by other delayed signals. Based on these advantages, the detection efficiency for the proton decay via $p\to \bar\nu K^+$ is 36.9% with a background level of 0.2 events after 10 years of data taking. The estimated sensitivity based on 200 kton-years exposure is $9.6 \times 10^{33}$ years, competitive with the current best limits on the proton lifetime in this channel

JUNO sensitivity on proton decay p → ν K + searches*

The Jiangmen Underground Neutrino Observatory (JUNO) is a large liquid scintillator detector designed to explore many topics in fundamental physics. In this study, the potential of searching for proton decay in the $p\to \bar{\nu} K^+$ mode with JUNO is investigated. The kaon and its decay particles feature a clear three-fold coincidence signature that results in a high efficiency for identification. Moreover, the excellent energy resolution of JUNO permits suppression of the sizable background caused by other delayed signals. Based on these advantages, the detection efficiency for the proton decay via $p\to \bar{\nu} K^+$ is 36.9% ± 4.9% with a background level of $0.2\pm 0.05({\rm syst})\pm$$0.2({\rm stat})$ events after 10 years of data collection. The estimated sensitivity based on 200 kton-years of exposure is $9.6 \times 10^{33}$ years, which is competitive with the current best limits on the proton lifetime in this channel and complements the use of different detection technologies