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Test de stérilité isolateur

A compact aseptic laboratory isolator that controls sterility testing through HEPA airflow, automated H2O2 decontamination and integrated membrane-filtration workstations.
  • Controlled Test Environment
  • Integrated Filtration Pumps
  • Rapid H2O2 Cycle
  • Monitored Test Workflow
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Introduction de produit

The sterility test isolator provides closed work chambers for membrane-filtration or direct-inoculation testing. Stainless construction, HEPA-controlled airflow and fixed glove access protect the test from room contamination, while a dedicated transfer airlock and automated hydrogen-peroxide cycle prepare incoming materials and internal surfaces. Integrated pumps, bottle racks and process monitoring support repeatable laboratory campaigns with fewer handling steps.

Key Features

Independent HEPA-controlled chambers support organized sterility test workflows.

Integrated membrane-filtration pumps reduce loose equipment and tubing inside the chamber.

Automated H2O2 decontamination treats both work chamber and material airlock.

Continuous pressure, cycle and environmental monitoring supports documented operation.

Préoccupations du client produit

Sterility testing is vulnerable to false positives from environmental ingress and false negatives if decontamination residues are not adequately aerated.

Room-borne organisms can contaminate exposed test assemblies.A sealed HEPA-controlled barrier isolates samples and media from the laboratory background.
Complex material entry increases contamination risk and test delay.A dedicated airlock decontaminates organized loads before chamber transfer.
Loose pumps and tubing create clutter and cleaning difficulty.Integrated filtration pumps and fixed racks simplify setup and surface access.
Inconsistent cycle records weaken investigation traceability.Automated controls record pressure, decontamination and aeration parameters for each run.

Les applications typiques

Pharmaceutical batch-release sterility testingMembrane-filtration microbiology testsDirect-inoculation sterility testsAseptic quality-control sample handling

Paramètres techniques

Typical construction values for a modular pharmaceutical sterility test isolator are listed below.

Matériaux de base316L stainless steel chambers with safety-glass windows and CSM or EPDM glove sleeves
Panneau épaisseur40-80 mm double-skin enclosure panels
Largeur effective1200-2800 mm test chamber width
Longueur maximaleUp to 4500 mm modular isolator length
Acier face épaisseur1.2-1.5 mm stainless steel skins
Densité Core80-140 kg/m³ for sealed panel infill
Conductivité thermique0.038-0.055 W/(m·K) for insulated panel infill
surface finieSatin 316L stainless steel with radiused, cleanable internal surfaces
Type jointContinuously welded chambers with gasketed windows, clamped HEPA housings and sealed transfer-airlock interface
CustomisationDisponible en fonction de l'application prévue et de l'environnement d'exploitation.

Options disponibles

Membrane-filtration or direct-inoculation workstationPositive or negative pressure operationIntegrated particle counter and air samplerWireless glove testing and data reporting

Planning a Sterility Test Isolator specification?

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