ISO class 5 isolator / aseptic / for cellular therapy / floor-standing

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Characteristics

  • Class:

    ISO class 5

  • Applications:

    aseptic, for cellular therapy

  • Configuration:

    floor-standing

  • Other characteristics:

    laminar flow, stainless steel, glove box

Description

Offering

Isolator systems will be custom designed to suit individual customer requirements but will generally include the following;

Ergonomic design generated with the aid of full scale mock-ups
Multiple chamber arrangements providing defined barriers between process steps, enhancing aseptic performance
Fully welded fabrications of 316L stainless steel, providing crevice free construction with internally radiused corners
On-board recirculation laminar flow are flow system guaranteeing Grade A /ISO 5 classification
Integration of proprietary devices e.g. RTP’s incubators, centrifuge and decontamination system etc.
Integrated viable / non-viable systems

Design Advantages
Main advantages of Cell Therapy Isolator compared to traditional Cleanroom operation:

cGMP compliant design
Increased sterility by reducing contamination risks (increased patient safety)
Smaller operational space
Reduced human interventions
Physical barrier and pressure differential
Hydrogen peroxide decontamination
Highly controller material flow
Full process equipment integration within grade A / ISO 5 environment
Easier process separation (dedicated chambers)
Different pressure regimes available within each chamber
Full gowning not required

Available Options
Continuous particle monitoring system
Hydrogen peroxide vapour generator integration
Automated multiple glove tester
RTP (Rapid Transfer Port)