JCE Biotechnology


Designs and manufactures custom containment and isolation systems and supporting equipment for hospitals, clinical pharmacies, laboratories, research institutes and industry. Offers isolators, transfer airlocks, automated surface bio-decontamination systems using vaporized sterilants, aseptic transfer interfaces, consumables and accessories. Provides qualification/validation (IQ/OQ/PQ/FAT), training, maintenance/technical assistance including remote support, and service contracts. Products and services are described as compliant with GMP/cGMP, ISO and related standards.

Industries

biotechnology
machinery-manufacturing
manufacturing
market-research
pharmaceutical

Nr. of Employees

small (1-50)


Patents

Disposable isolator and product conditioning installation comprising such a disposable isolator

US-11389976-B2

View Details

Products

Isolators and containment systems

Custom-configured isolators for hospital, laboratory, research and industrial applications, including controlled-atmosphere units and configurations for aseptic manufacture and handling.

Automated bio-decontamination systems for sealed equipment

Mobile or integrated vaporized sterilant devices configurable to chamber volume with touchscreen control, USB/printer data export, automated programming and validation to achieve required sporicidal reductions.

Aseptic transfer systems and secure transfer containers

Interlocked transfer doors, connector systems, tubing and rigid/flexible transfer containers designed for aseptic product transfer and secure evacuation of hazardous or contaminated materials without breaking containment.

Consumables, waste containers and sterile packaging

Single-use sleeves, gloves, rigid HDPE and flexible polymer transfer/waste containers, and sterile packaging options including gamma-sterilized configurations and traceability.

Accessories and specific equipment for controlled environments

Monitoring and control systems, particle counters, aerobiocollectors, glove and sleeve testers, welding/sealing machines, syringe drivers, containment suction devices, lifting columns, UPS and compressors for integration with isolators and cleanroom workstations.


Services

Inspection and documented qualification and validation of equipment and controlled environments to demonstrate compliance with design and GMP requirements.

After-sales hotline, preventive and corrective maintenance, remote maintenance setup and service contracts to maintain equipment uptime and functionality.

Tailored training programs for users, supervisors and technical personnel covering safe operation, protocols and maintenance of containment systems and associated equipment.

Expertise Areas

  • Containment engineering and isolator systems
  • Automated vapor sterilization and bio-decontamination
  • Aseptic transfer design and leak-tight transfer interfaces
  • Qualification and validation (IQ/OQ/PQ/FAT)
  • Show More (5)

Key Technologies

  • Hydrogen peroxide vapor sterilization
  • Peracetic acid vapor sterilization
  • Mass-flow-based sterilant dosing and electronic cycle control
  • HEPA and ULPA filtration
  • Show More (9)

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