Sterility testing isolator

Description

Sterility testing isolator

MATERIALS:

  • Stainless Steel AISI 316L and glass
  • PMMA (Polymethylmethacrylate with Stainless Steel AISI 316L working base)
  • Soft wall (PVC Flexible Chambers with Stainless Steel AISI 316L working base)

CONFIGURATION:

  • 2 Gloves
  • 2 Gloves and one Airlock
  • 3 Gloves
  • 3 Gloves and one Airlock
  • 4 Gloves
  • 4 Gloves and one Airlock
  • 4 Gloves and two Airlocks
  • Half Suit
  • Customized configurations

AIRLOCK FOR FAST DECONTAMINATION AND MATERIAL TRANSFER:

  • Possibility to install one or two lateral transfer airlock
  • Fast decontamination cycle
  • Sliding trolley with Basket and hooks

BIODECONTAMINATION SYSTEM:

  • Integrated H2O2 (Vapour Hydrogen Peroxide 35%) biodecontamination system
  • H2O2 HPV
  • H2O2 35% - 1 Liter bottles with safety system for operator safety

AUTOMATION:

  • PLC Siemens or other brands on request
  • HMI - PANEL PC Windows based
  • GAMP 5 - CFR 21 Part 11 compliant

GENERAL TECHNICAL SPECIFICATIONS :

  • Ventilation System ETF (Engineered Turbulent Airflow)
  • UDAF (Unidirectional Airflow)
  • Filtration by HEPA filters H14 or ULPA U15
  • Regulated pressure positive or negative
  • RTP Rapid Transfer Port for waste management (solid and or liquid)
  • Microbial Air Sampler integration as option for environmental monitoring
  • Particle Counter integration for environmental
  • Sterility pump integrated (mechanical and electrical integration)
  • H2O2 sensors for the concentration measurement inside the isolator during the process
  • H2O2 sensor for the concentration measurement in the room (operator safety)
  • GLT Glove Leak Tester – Integrate or with dedicated software interface

Brand

JCE BIOTECHNOLOGY

JCE BIOTECHNOLOGY, with more than 25 years’ experience in the design, manufacture and maintenance of customized isolators and personalized solutions for isolation technology, offers a broad range of equipment and products that comply with the constantly changing regulatory requirements, the specific need of clean rooms and other controlled environments, and the protocols inherent in various activity sectors:
  • Isolators
  • Bio-decontamination systems
  • Transfer airlocks
  • Secure RTP (Rapid Transfer Port)-type transfer systems
  • Range of accessories and single-use consumables