目錄:蘇州采石儀器有限公司>>配液系統、勻漿罐>> 全自動配液系統(LPS)
全自動配液系統(LPS):
全自動配液系統是制藥生產過程中的常用設備之一,應用在無菌制藥中的無菌制劑,生物制劑,疫苗,等藥品生產中,在生物制藥工程等行業的生產中,為了使產品在生產過程中不受交叉污染的風險,每個程序的設計必須達到高質量的要求,自動配液系統的單元設計是對生產工藝的要求實現快速響應及降低生產成本和能耗的具體體現
全自動配液系統模塊設計制造,是指將配液儲罐和物料管道系統集成在一個模塊中,在工廠內進行預安裝和調試適用于小儲罐的配液系統。系統可全面實現配液化自動操作,生產過程中通過對稱重系統,液位控制系統,電導,PH,溫度,壓力,流速,流量參數設定,可實現流程全自動控制,觸摸屏的人機界面,實現動態平衡,生產實施數據歷史追溯和報表打印,并可與上位機實現通訊和控制,該系統操作簡單,性能可靠,避免人為誤操作,提高配液生產能效和品質。同時我們擁有的質量控制體系,為用戶提供需求的技術規范和各種驗證支持,以確保產品質量的可追溯性
項目名稱 | 參數設置 |
全自動配液系統 | 應用于抗體,無菌制劑,生物制劑,疫苗,等生產 |
設計體積 | 1L-5000L |
流量 | 1-2000L/H |
稱重模塊 | 1-10T |
液位控制 | 有 |
電導 | 0.1-999 ms/cm |
PH | 0-14 |
壓力 | 0.1-10bar |
控制 | PLC |
防護等級 | IP65以上 |
數據記錄 | 可追溯 |
文件 | 符合cCMP要求,DQ(設計確認),IQ(安裝確認),OQ(性能確認,PQ(工藝確認) |
在線配液設計要求
1.符合cGMP設計原則
2.集成設計,可以有效節省空間
3.記錄與保證批次生產和清洗過程的參數和步驟,數據可追溯
4.,易清洗,易維護
5.全自動配液與傳輸過程
6.在線自動CIP清洗系統(自動檢測電導率)
7.在線自動SIP滅菌系統(自動測溫與記錄)
8.在線自動補水稱重定容系統
9.在線過濾器完整測試系統
自動配液系統結構特點
●配置:機械密封:硬密封,
●稱重系統:可實現自動稱重
●壓力表:在線壓力控制
●呼吸器:在線無菌
●磁力攪拌:可實現配液過程中攪拌
●罐底閥:無菌設計
●控制系統:DCS控制系統,采用集成控制、液晶屏、觸摸屏顯示人機界面
●自動配液系統執行標準:GMP、FDA、COS、GB150-1998、HG/T20569-94、HG/T20584-1998、HG/T20583-1998
設計體積:10L/H-2000L/H,或根據客戶可定制
Full automatic liquid preparattem:
The fully automatic solution preparattem is one of the commonly used equipment in the pharmaceutical productionprocess. It is used in the production of sterile preparations, biologicalpreparations, vaccines, eye drops and other drugs in the sterile pharmaceuticalindustry. In the production of biopharmaceutical engineering and other industries,in order to avoid the risk of cross contamination in the production process,the design of each program must meet the requirements of high quality, The unitdesign of automatic liquid preparattem is a concrete embodiment ofrealizing rapid response to the requirements of production process and reducingproduction cost and energy consumption
The design and manufacture of the fullyautomatic liquid dispensing system module refers to the integration of theliquid dispensing tank and the material pipeline system into one module, andthe pre installation and commissioning of the liquid dispensing systemapplicable to small tanks in the factory. The system can fully realize theautomatic operation of dispensing liquefaction. During the production process,through the setting of weighing system, liquid level control system,conductivity, PH, temperature, pressure, flow rate and flow parameters, thesystem can realize the full automatic control of the process. The man-machineinterface of the touch screen can realize dynamic balance. The productionimplementation data can be traced back and printed, and communication andcontrol can be realized with the upper computer. The system is simple inoperation, reliable in performance, and can avoid manual misoperation, Improvethe energy efficiency and quality of liquid preparation. At the same time, wehave a perfect quality control system to provide users with required technicalspecifications and various verification support to ensure the traceability ofproduct quality
Entry name | Parameter setting |
Full automatic liquid preparattem | It is used in the production of antibodies, sterile preparations, biological agents, vaccines, eye drops, etc |
Design volume | 1L-5000L |
flow | 1-2000L/H |
Weighing Module | 1-10T |
level control | have |
conductance | 0.1-999 ms/cm |
PH | 0-14 |
pressure | 0.1-10bar |
control | PLC |
Degree of protection | Above IP65 |
data record | Traceability |
file | Conform to cCMP requirements, DQ (design qualification), IQ (installation qualification), OQ (performance qualification, PQ (process qualification)) |
Design requirements for online liquidpreparation
1. Comply with cGMP design principles
2. Integrated design can effectively savespace
3. Record and ensure the parameters andsteps of batch production and cleaning process, and the data is traceable
4. No dead corner, easy to clean andmaintain
5. Fully automatic liquid preparation andtransmission process
6. Online automatic CIP cleaning system(automatic conductivity detection)
7. Online automatic SIP sterilizattem (automatic temperature measurement and recording)
8. Online automatic water supplement,weighing and constant volume system
9. Complete test system of online filter
Structural features of automatic liquiddispensing system
● Configuration: mechanical seal: hard seal, no dead angle
● Weighing system: automatic weighing
● Pressure gauge: online pressure control
● Respirator: online sterile
● Magnetic stirring: it can realize stirring during liquidpreparation
● Tank bottom valve: aseptic design
● Control system: DCS control system, which adopts integratedcontrol, LCD screen and touch screen to display human-machine interface
● Executive standards of automatic liquid preparattem: GMP,FDA, COS, GB150-1998, HG/T20569-94, HG/T20584-1998, HG/T20583-1998
Design volume: 10L/H-2000L/H, or customizedaccording to customers