苏州采石仪器有限公司COSTONES

搜索
友情链接

https://www.nmpa.gov.cn/datasearch/home-index.html#cate

在线客服
 工作时间
周一至周六 :8:30-18:30
 联系方式
电话:1866 2572 885
邮箱:pangjun@costones.com
产品详情

全自动配液系统(LPS)

产品详细介绍

全自动配液系统(LPS): 

全自动配液系统是制药生产过程中的常用设备之一,应用在无菌制药中的无菌制剂,生物制剂,疫苗,滴眼液等药品生产中,在生物制药工程等行业的生产中,为了使产品在生产过程中不受交叉污染的风险,每个程序的设计必须达到高质量的要求,自动配液系统的单元设计是对生产工艺的要求实现快速响应及降低生产成本和能耗的具体体现

全自动配液系统模块设计制造,是指将配液储罐和物料管道系统集成在一个模块中,在工厂内进行预安装和调试适用于小储罐的配液系统。系统可全面实现配液化自动操作,生产过程中通过对称重系统,液位控制系统,电导,PH,温度,压力,流速,流量参数设定,可实现流程全自动控制,触摸屏的人机界面,实现动态平衡,生产实施数据历史追溯和报表打印,并可与上位机实现通讯和控制,该系统操作简单,性能可靠,避免人为误操作,提高配液生产能效和品质。同时我们拥有完善的质量控制体系,为用户提供需求的技术规范和各种验证支持,以确保产品质量的可追溯性

项目名称

参数设置

全自动配液系统

应用于抗体,无菌制剂,生物制剂,疫苗,滴眼液等生产

设计体积

1L-5000L

流量

1-2000L/H

称重模块

1-10T

液位控制

电导

0.1-999 ms/cm

PH

0-14

压力

0.1-10bar

控制

PLC

防护等级

IP65以上

数据记录

可追溯

文件

符合cCMP要求,DQ(设计确认),IQ(安装确认),OQ(性能确认,PQ(工艺确认)

在线配液设计要求

1.符合cGMP设计原则

2.集成设计,可以有效节省空间

3.记录与保证批次生产和清洗过程的参数和步骤,数据可追溯

4.无死角,易清洗,易维护

5.全自动配液与传输过程

6.在线自动CIP清洗系统(自动检测电导率)

7.在线自动SIP灭菌系统(自动测温与记录)

8.在线自动补水称重定容系统

9.在线过滤器完整测试系统

自动配液系统结构特点

  ●配置:机械密封:硬密封,无死角

  ●称重系统:可实现自动称重

  ●压力表:在线压力控制

  ●呼吸器:在线无菌

  ●磁力搅拌:可实现配液过程中搅拌

  ●罐底阀:无菌设计

  ●控制系统:DCS控制系统,采用集成控制、液晶屏、触摸屏显示人机界面

  ●自动配液系统执行标准:GMP、FDA、COS、GB150-1998、HG/T20569-94、HG/T20584-1998、HG/T20583-1998

设计体积:10L/H-2000L/H,或根据客户可定制



Full automatic liquid preparation system:

The fully automatic solution preparationsystem 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 preparation system 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 preparation system

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 sterilizationsystem (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 preparation system: GMP,FDA, COS, GB150-1998, HG/T20569-94, HG/T20584-1998, HG/T20583-1998

Design volume: 10L/H-2000L/H, or customizedaccording to customers