摘要
純水應用於製藥、食品、化妝品、前端原料等產業，純水在產品生產過程中使用最廣、用量最大是廣泛應用的物質之一，純水品質會直接影響產品品質及穩定，所以如何制定符合生產產品的用水規範，應考慮產品生產製程及水質對產品終端的需求性。因此在純水生產、儲存與配送過程中控制水質，其中微生物是主要關注的問題。 近年來藥廠、保健食品廠、保養品廠相關認證稽核都要求製造廠提供相關確效作業，本研究以某生技廠之純水系統來探討，參考[水系統確效作業指導手冊]執行純水系統確效，純水系統中各處理單元活性碳床、去離子樹脂、過濾膜、逆滲透等依每個單元處理特性設定檢驗項目及規格，純水水質則依藥典純淨水規範設定規格，經由各單元檢驗所獲得之數據進行統計分析，制訂各處理單元水質規範之警戒值將檢驗規格設定為行動值，確認微生物、總有機碳TOC與導電度數據皆符合水質規範，確實能持續穩定達到與世界先進國家同步之稽查與管理目標。 系統原水來源採用自來水經檢驗均符合飲用水標準，性能驗證(PQ) 第一階及第二階段各連續四週(共八週)每日監測前處理單元水質分析上均符合所設定規格，純水處理單元品質結果顯示每日水質均可符合藥典純淨水規範，第三階段以記錄造水時之各項水質數據，同時長期監控微生物為主要目標，第三階段持續一年，研究發現前處理單元小循環端所測得微生物較為偏高，純水段水質TOC及導電度則差異不大，微生物數據差異也無明顯變化，綜合以上數據此套純水設備是可以達到穩定純水品質。
並列摘要
Pure water is used in pharmaceutical, food, cosmetics, front-end raw materials and other industries. Pure water is one of the most widely used substances in the production process, Pure water quality will directly affect product quality and stability, The water quality requirements of the product manufacturing process and the product end should be considered.Therefore, the quality of water must be controlled during the production, storage and distribution of pure water, and microorganisms are the most important problem. In recent years, the relevant certification audits of pharmaceutical factories, health food factories, and care products factories have required manufacturers to provide relevant validation operations, This study discusses the pure water system of a biotechnology plant, and refers to the [Water System Validation Operation Guide Manual] to perform the pure water system validation, In a pure water system, the activated carbon bed, deionized resin, osmosis membrane, reverse osmosis, etc. of each processing unit are set according to the characteristics of each unit set inspection items and specifications, Pure water quality is set according to the Pharmacopoeia Pure Water Specification, statistical analysis of the data obtained through the inspection of each unit,formulate alert values for water quality specifications for each treatment unit and set inspection specifications to action values, Confirm that microorganisms, total organic carbon TOC and conductivity data meet water quality specifications, Indeed, it can continuously and steadily achieve the audit and management goals synchronized with the advanced countries in the world. The system's raw water source uses tap water and has been tested to meet drinking water standards, Performance Verification (PQ) Stages 1 and 2 for four consecutive weeks (eight weeks in total)the water quality analysis before the daily monitoring of the pretreatment unit meets the set specifications, Pure water treatment unit quality results show daily the water quality complies with the pharmacopoeia pure water specifications, the third stage is to record various water quality data during Water quality data, At the same time, long-term monitoring of microorganisms is the main goal, the third stage lasts one year, the study found that the microorganisms detected at the small circulation end of the pretreatment unit were relatively high, there is little difference in TOC and conductivity of pure water, no significant change in microbial data, According to the above data, this set of pure water equipment can achieve stable pure water quality.