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Overview

DEC aseptic isolator with glove ports

DEC’s aseptic isolator range delivers Grade A (ISO 5) sterile environments positioned within lower-grade cleanrooms, reducing facility classification requirements while maintaining the highest sterility assurance. Integrated VPHP (vapor-phase hydrogen peroxide) bio-decontamination eliminates the need for manual surface disinfection between batches.

Standardized modular designs accelerate project timelines and enable rapid capacity scaling. DEC aseptic isolators serve pharmaceutical fill-finish, sterile compounding, cell and gene therapy manufacturing, and sterility testing applications.

Key Specifications

EnvironmentGrade A (ISO 5) inside Grade D (ISO 8) cleanroom
DecontaminationIntegrated VPHP via gas generator
PressurePositively pressurized relative to room and ante chambers
MonitoringViable and non-viable particle counting close to process
Construction304/316L stainless steel
DesignModular — scalable capacity
ManufacturingSwiss headquarters, manufacturing in Poland, UK, and US
DEC aseptic isolator fill-finish line

Key Features

Grade A in Grade D

Isolators maintain ISO 5 conditions at the point of fill, allowing the surrounding cleanroom to operate at a lower classification. This reduces facility build-out cost and ongoing environmental monitoring burden.

Integrated VPHP Decontamination

Vapor-phase hydrogen peroxide bio-decontamination is built into the isolator, delivering validated sterility between batches without manual surface wiping.

Modular Scalability

Standardized isolator modules can be combined and reconfigured as production needs change, enabling rapid capacity scaling for growing programs.

Cell & Gene Therapy Ready

Positively pressurized chambers with close-to-process particle monitoring. Proven in clinical use for mesenchymal stromal cells, autologous keratinocytes, and stem cell transplant processing.

Applications

  • Aseptic fill-finish for vials, syringes, cartridges, and IV bags
  • Sterile powder handling and compounding
  • Cell and gene therapy manufacturing
  • Sterility testing
  • Clinical and commercial sterile manufacturing

MHS Pharma — Northeast US Representative

MHS Pharma provides direct technical representation for DEC Group across the Northeast United States. Contact us to discuss aseptic isolator solutions for your application.

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