JCE Biotechnology


Manufacturer and integrator of custom isolators, transfer systems and bio-decontamination solutions for pharmaceutical, hospital and research environments. Offers end-to-end services including design, manufacturing, qualification/validation (QI/QO/QP, FAT/SAT), installation, training and maintenance, with stated compliance to GMP and ISO9001.

Industries

Biotechnology
Machinery Manufacturing
Manufacturing
Market Research
Pharmaceutical

Nr. of Employees

small (1-50)

JCE Biotechnology


Patents

Disposable isolator and product conditioning installation comprising such a disposable isolator

US-11389976-B2

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Products

Isolators for pharmaceutical manufacturing

Custom and standard isolators for sterile and toxic environments supporting applications such as aseptic filling, cytotoxic preparation, ATMP handling and sterility testing.

Isolators for hospitals and clinics

Containment isolators for hospital use, including drug reconstitution, cytotoxic handling and preparation of parenteral nutrition.

Isolators for laboratories and research institutes

Standard and customized isolators for laboratory research, confinement, cell and gene therapy work, and in vitro culture applications.

Pass-through transfer systems with bio-decontamination

Pass-through hatches and transfer containers with integrated automated bio-decontamination cycles for secure material transfers between controlled zones.

Mobile bio-decontamination sterilizer (mobile VHP unit)

Autonomous mobile unit for in-situ decontamination of isolators and confined enclosures using vaporized hydrogen peroxide with controlled, recordable cycles.

Glove and sleeve integrity tester (pressure-based)

Equipment to perform integrity tests on gloves and sleeves by pressurization/depressurization and monitoring for leaks, with ergonomic interface and optional mobile cart integration.

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Services

Project scoping, URS, mock-ups and bespoke mechanical/electrical design for isolators and containment solutions.

Workshop fabrication and integration of isolators and transfer systems according to controlled production processes.

Execution of QI, QO, QP and acceptance tests (FAT, SAT) to document compliance and performance.

On-site installation, commissioning and user training to ensure correct operation and transfer of competencies.

Preventive and corrective maintenance programs, hotline support and secure remote access for diagnostics and remediation.

Expertise Areas

  • Isolator and containment system design
  • Aseptic and sterile process equipment
  • Bio-decontamination and sterilization processes
  • Qualification and validation of containment systems
  • Show More (4)

Key Technologies

  • Isolator enclosures (stainless steel 316L, PMMA)
  • Vaporized hydrogen peroxide (VHP) decontamination
  • Peracetic acid bio-decontamination
  • Pressure-based glove and sleeve integrity testing
  • Show More (4)

News & Updates

Exhibitor presence and stands at sector events including GERPAC, AFIB, CPHI Milan and A3P Biarritz (dates listed for 2026).

Article and demonstration video describing a flexible solution for waste handling under isolators, RABS and microbiological safety cabinets to reduce contamination risk.

Company blog article reflecting on company history and community milestones since founding in 1992.

Article describing the role of glove and sleeve integrity testing equipment for maintaining isolator containment per GMP and Annex 1.

Obtained ISO 9001 certification.

Founded in 1992; over 30 years of activity in designing and manufacturing isolators and containment solutions.


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