注射用水設備

用途與簡介/Brief Introduction：

注射用水設備注射用水是純化水經(jīng)蒸餾所得，細菌內毒素等指標均符合中國藥典注射用水項下規(guī)定的水質要求，可作為生物制藥企業(yè)中各類直接注射入人體內藥物的溶劑。注射用水設備主要包括注射用水制備、循環(huán)儲存、動態(tài)分配和工藝控制等主要模塊。

特點/Characteristic：

◆全自動操作方式，防止人員誤操作帶來的生產(chǎn)損失；

Automatic operation mode, to prevent losses of wrong operation of production;

◆部件采用316L材質；

Components in 316L texture

◆帶PLC控制的CIP產(chǎn)品；

CIP products with PLC control

◆記錄與保存清洗過程的參數(shù)與步驟；

Record and save the parameters of the cleaning process and steps

◆滿足GMP要求的可追溯性與可說明性； 

Meet GMP requirements traceability and accountability

◆一體化設計可有效節(jié)省空間；

Integrated design can effectively save space

◆實現(xiàn)生產(chǎn)和清潔的快速切換；

Implement production and clean fast switching

◆巴氏消毒殺菌，清洗更；

Babbitt disinfection sterilization, cleaning more thoroughly

◆多效蒸餾機：整機管路連接全部采用自動焊接，按衛(wèi)生級標準，閥門采用快卡連接，杜絕了注射用水的二次污染；

Multi-effect distillation machine: the machine connection all adopt the automatic welding, according to the level of health

standard, the valve with fast connection, to eliminate the secondary pollution of water for injection

◆純蒸汽發(fā)生器：PLC人機操作控制界面，可0-99%自動調節(jié)至需要的產(chǎn)量要求；

The pure steam generator: PLC man-machine interface operation, can be 0-99% automatically adjust to the need of production requirements

◆3D設計：注射用水系統(tǒng)潔凈管路滿足GMP3D要求，膠墊為PTPE/EPDM，隔膜閥水平安裝時為45度，循環(huán)管線安裝設為0.5的坡度，設低點為排放點,并以湍液狀態(tài)循環(huán)流動的貯存和輸送系統(tǒng)，防止微生物的滋生；

3 d design without dead Angle: clean water for injection system satisfies the requirement of GMP3D tube, rubber pad of PTPE/EPDM, when mounted horizontally is 45 degrees, the diaphragm valve loop pipeline installation set as 0.5 grade, set low emission points, and the turbulent fluid state circulating storage and conveying system, prevent microbes breeding

◆完整的文件系統(tǒng)：①文件符合GMP要求；②自動化控制系統(tǒng)可符合GAMP5；③3Q文件滿足制藥廠驗證的需要。

Complete the file system: (1) documents conform to GMP requirements; (2) automatic control system can meet GAMP5; (3) 3 q documents meet the needs of the pharmaceutical factory to verify

◆配備高性能變頻泵用以輸送和分配注射用水。

Equipped with high performance variable frequency pump used to transport and distribution of water for injection

◆雙板換熱器，在純化水長時間循環(huán)過程中起到冷卻作用。

Double plate heat exchanger in the purified water cooling effect in the process of long cycle

◆注射用水貯罐優(yōu)先采用立式貯罐其次臥式貯罐，滿足輸送泵水位要求，科學設置罐內流速防止生物膜形成。

Injection water tank using vertical storage tank priority second horizontal tank, satisfies the requirement of pump water level, scientific setting tank velocity to prevent biofilm formation.

◆采用80℃以上保溫循環(huán)設計，防止用水系統(tǒng)微生物滋生和污染。

Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system

◆配備帶電加熱（蒸汽加熱）呼吸過濾器。

Equipped with electric heating, steam heating) breathing filter

◆罐底出水口加設錐形擋板以擴大采水面，防止渦流。

Adding bottom outlet conical baffle to expａnd in the water, prevent eddy current

◆貯罐接入采用氮氣保護，維持制藥用水儲存及分配系統(tǒng)正壓，防止外部回流污染。

Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination

◆制藥用水輸送泵采用316L不銹鋼制造（浸水部分），電拋光并鈍化處理。

Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment

三、系統(tǒng)工藝流程圖