無菌隔離器是一種垂直單向流動裝置,可提供局部a級環境。 在有毒的API工藝過程中保護操作人員,並保持持續清潔。 特點:動態A級環境,全封閉物理屏障,即時監控,現場淨化
Product Introduction
The sterile isolator is a vertical unidirectional flow device that provides a local Class A environment. It offers effective safety protection for the delivery, filtration, drying, crushing, weighing, and other sub-packaging processes of toxic or highly allergenic active pharmaceutical ingredients. It provides reliable protection for the safety and health of operating staff. While ensuring that the clean space is not affected by material transfer and personnel operations, the sterile isolator also solves the problem of traditional sterile rooms that cannot maintain a Class 100 cleanliness level continuously.
Product Features
1. Provide a continuously controllable and dynamic Class A clean environment
2. Provide a fully enclosed physical barrier to prevent direct contact between operators and products, thereby addressing the issue of microbial contamination
3. It can conduct real-time monitoring of sedimentation bacteria, temperature, humidity, pressure, and wind speed in the environment to ensure the production environment
4. Each compartment of the isolator is equipped with multi-functional interfaces, allowing for the configuration of detection equipment such as online planktonic bacteria and dust particle collection, and featuring in-situ biological decontamination capabilities
5. It can record the entire filling production process, ensuring data traceability. With automated and intelligent operations, it reduces labor costs
操作員是主要的污染源。隔離器消除了操作員與產品的接觸。外部資料用過氧化氫(log-6 SAL)進行淨化。HEPA過濾的層流保持無菌條件。