無菌隔離器

概述:

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

關鍵字:
VHP可消毒隔離器、無菌填充隔離器、手套洩漏測試、生物淨化迴圈、封閉或開放系統、無菌傳輸埠、隔離器淨化驗證、GMP附件1合規性

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

1

安裝隔離器有哪些優點?

>; 隔離器安裝在D/C級空間(不是B級),將空氣交換要求降低了100倍。 更容易清潔不銹鋼表面。 减少機密空間迫使資源得到有效利用。

2

為什麼隔離器優於傳統的潔淨室?

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。

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