产品简介Product Introduction
符合GMP规范要求的隔离装置，设备全密闭，确保背景环境、操作人员与药品、操作物品的有效隔离，避免交叉污染；隔离器集成汽化过氧化氢灭菌系统，内部环境为A级，为用户带来一个高度洁净、持续有效的操作空间，能最大限度降低微生物、各种微粒和热原的污染，实现生产全过程的无菌保障，特别适用于无菌（有毒）产品的研发和小试生产。
Isolation device that meets GMP requirements, with fully enclosed equipment, ensuring effective isolation of background environment, operators from drugs and operating items, and avoiding cross contamination; The isolator integrates a vaporized hydrogen peroxide sterilization system, with an internal environment of Class A, providing users with a highly clean and continuously effective operating space. It can minimize the pollution of microorganisms, various particles, and pyrogens, and achieve aseptic protection throughout the production process. It is particularly suitable for the research and development of sterile (toxic) products and small-scale trial production.
产品优势Product Advantages
设计结构经过流体软件分析，气流流型、压差和风速控制有保证；
The design structure has been analyzed by fluid software, ensuring the control of airflow flow pattern, pressure difference, and wind speed;
上位机采用平板电脑，PID显示，界面友好，实现电子签名、批记录、数据报表、历史曲线、审计追踪和历史报警等多重数据分析处理；
The upper computer adopts a tablet computer with PID display and a user-friendly interface, achieving multiple data analysis and processing such as electronic signatures, batch records, data reports, historical curves, audit trails, and historical alarms;
集成式汽化过氧化氢灭菌系统，可快速灭菌并达到log6的灭菌效果；
The integrated vaporized hydrogen peroxide sterilization system can quickly sterilize and achieve the sterilization effect of log6;
配置袋进袋出过滤器系统，保证人员安全更换；
Configure a bag in and bag out filter system to ensure safe replacement of personnel;
在线环境监测系统集成度高，采样管路可在线灭菌，报表独立生成；
The online environmental monitoring system has high integration, sampling pipelines can be sterilized online, and reports can be generated independently;
木模模拟，保证手套的布置满足客户工艺操作需求，人员操作舒适；
Wood mold simulation ensures that the arrangement of gloves meets the customer's process operation needs and personnel operate comfortably;
可配置RTP，可用于小型器具及物料的快速无菌转运。
RTP can be configured, which can be used for rapid and sterile transfer of small instruments and materials.
