RABS Restricted Access Isolation System

NegotiableUpdate on 02/15

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Nature of the Manufacturer: Producers

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Overview

RABS restricted access isolation system $n is used for aseptic processes, A/B levels, non sterile, and contact with products through glove devices

Product Details

　　RABS Restricted Access Isolation System

Used for aseptic processes, A/B grade, non sterile, and contact with products through glove devices

　　Advantage:

Increase sterile safety

Increase product safety

Increase personnel safety

Reduced the demand for special clean work clothes

Reduce initial investment and expansion investment

Reduce the demand for clean rooms

Reduce the demand for ventilation systems

Reduce the quality requirements for the expansion of surrounding production areas

Reduced electricity demand

1. Chapter 4 Isolation Operation Technology of the 2010 version of GMP states that "Article 14: Operations with high pollution risks should be completed in isolation operators. The design of the isolation operator and its environment should ensure that the air quality in the corresponding area meets the set standards. The transmission device can be designed as a single door or double door, or as a fully sealed system connected to the sterilization equipment;

2. Special attention should be paid to preventing contamination when operating isolation devices for goods entering and exiting;

3. The environment in which the isolation operator is located depends on its design and application. The environment in which the isolation operator for aseptic production is located should be at least a Class D clean area;

The RABS system consists of laminar flow system, enclosure system, glove box, small door system, and control system.

The main functions include one-way flow protection, system enclosure, glove box or small door system, integrity testing hole, and online monitoring of pressure difference.

The main configuration and features of the system include: using FFU system for one-way flow to minimize leakage; Adopting a uniform flow membrane to minimize component exposure and facilitate cleaning; Aluminum alloy or stainless steel bracket; PC or tempered glass enclosure; Built in connectors; Sanitary hinges and pins; Imported glove box.