STERILITY TEST ISOLATOR: BQ QUBE

STERILITY TEST ISOLATOR: BQ QUBE

  • Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeia to determine acceptability of the production lot.
  • The Bioquell Qube sterility test isolators are designed to avoid this risk and protect the product from both the process and externally generated factors that would compromise its quality.
  • The Bioquell Qube sterility test Isolator has been developed to cover a wide variety of clients needs.The units ability to provide a reliable aseptic environment for sterility testing and other aseptic processes is unquestioned.
  • A minimum of 6-log sporicidal reduction in spore forming micro-organisms is consistently achieved & validated using a BI challenge.
  • The Isolator complies fully with ISO 14644-7:2004 Producing an EU GMP Grade A environment throughout the chamber.

Features

  • Single pass turbulent flow (EU GMP graded A) to maintain sterile conditions inside the isolator.
  • Inflatable seal technology on all doors assures very low leakage rate in compliance with the most stringent leakage criteria, stated in ISO 14544-7.
  • Integrated VHP Generator offers the most cost effective bio-decontamination solution with short cycle.
  • Automatic leak testing procedure for the whole work area.
  • Internal Temperature, Humidity, H2O2 ppm, Pressure & Airflow monitoring sensors.
  • Grade AISI 316L Stainless steel of work floor.
  • Lighting fixtures within each chamber with external access for maintenance.
  • Unbroken integrity/sterility when transferring goods in & out of the isolator.
  • Has Positive/Negative pressure with alarm set points to avoid any product contamination.
  • Ergonomic design with multiple chambers.
  • Integrated catalytic converter to break down H2O2 – no HVAC installation required.
  • A Modem ISO 5 Grade A classification chamber with uni-directional air flow.
  • H14 (FILTRATION EFFICIENCY OF 99.005%)HEPA Filters are used for inlet,Outlet and recirculation.
  • Ergonomically designed for operation comfort.
  • Touch screen & friendly HMI are designed for easy operation of the isolator.
  • Full process equipment integration of Millipore Steritest Unit or Sartorius Sterisart(Optional).
  • Hydrogen Peroxide Decontamination ready.
  • Bright range of Services
    • Installation and commissioning.
    • Isolator Qualification IQ/OQ & Decontamination cycle development.
    • Document Operator Training.

Applications

• Sterility Test
• Hospital Pharmacy
• Life Sciences research
• Clinical trials

Options

Factory Fitted Options

  • Bio-Decontamination system
  • Sterility Test Pump
  • Glove Tester
  • Thermal Printer
  • H2O2, Temp & RH% Monitoring Sensors
  • Internal Shelving & Racking

Ancillary Options

  • Non Viable Monitoring
  • Viable Monitoring

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