Sterile Isolators for Aseptic Environments
Overview
Photos
Aseptic Isolator
- Cleanliness class: A class (Iso 5)
- Tightness class: 3 or 2
- Flow equipment: unidirectional (laminar) vertical
- Regulation: temperature, pressure, excess pressure, humidity
Customised Technical Solution
Static and Dynamic Protection
Quick Installation and Implementation
Easy-to-clean Surface
Features
Features of the EREA Pharma pharmaceutical isolator:
- Overpressure operation ;
- Cleanliness class: A class (ISO 5) at rest;
- Flow: Vertical laminar ;
- Tightness class 3 ;
- HEPA H14 filtration;
- Open loop ventilation ;
- EMERY 100% inlet;
- Materials: 100% 316 L stainless steel;
- Roughness: 0.8 μm indoors and 1.2 μm outdoors;
- Static & dynamic containment ;
- Safety lock with inflatable seals;
- Opening door with gas cylinder;
- Touch screen: HMI ;
- Dimmable LED lighting.
Options
- Bio-decontamination
- Aerobiocollector
- Particle counter
- Batch report
- Audit Trail
Applications
Specific uses:
- Filling
- Sterility test
- Formulation
How it works
Vacuum or mixed operation:
- Integrated bio-decontamination ;
- Aero-biocollector ;
- Particle counter ;
- Hygrometry setpoint ;
- Nitrogen setpoint ;
- Peristaltic pump ;
- Batch report ;
- Audit Trail ;
- Watertightness class 1 / 2 ;
- Roughness: up to 0.4 μm indoors;
- Customisable work surface ;
- RTP port ;
- ULPA U15 supply filtration;
- Double filtration at supply;
- BIBO return filtration;
- Double filtration on return ;
- Closed loop ventilation (recirculation or AHU) ;
- ATEX version ;
- Partitioning ;
- Mock-up ;
- Glove tester.
Operating Principle
The isolator is maintained at a constant pressure thanks to an integrated air treatment system of class ISO 5 (NF, EN, ISO 14644-1). Handling inside the enclosure is carried out using gloves. Transfers can be made via a decontamination SAS or a system of sealed transfer doors.
Materials and Specificities
Equipment entirely constructed (box, airlock, piping, ventilation, frame) out of highly radiated stainless steel sheet (internal radius of 30mm), brushed on the outside and “mirror polished” inside. All the sheet metal is welded under Argon atmosphere with the welds being sanded and repolished. Glove rings installed on a safety glass (removable) placed on the front face of the insulator allow for perfect visibility and accessibility for the operators.
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