KLENZAIDS

Isolator > IsoKlenz®

The Process

IsoKlenz® Isolators for Aseptic applications are designed & built to operate filling, stoppering, lyophilisation, capping and container transport under Grade A conditions within a background of Grade C/D. These installations typically surpass even the most stringent cGMP regulatory guidance. Going beyond limiting the processing perimeter as in the case of CRABS these isolators provide hermetics, bio-decontamination and advanced climate control. This process is therefore sustainable in Grade C/D settings and lowers the cost of clean room establishment and related management & qualification.

The Product

  • IsoKlenz® Isolators
  • Grade A ( for install in Grade C/D)
  • For both Non Potent and Potent products/applications
  • Installed on various filling, closing, capping, lyophilisation and transport equipment
    Includes:
  • Laminar & UDAF
  • Air diffusers
  • Hermetic light fixtures
  • Gloves and safety barriers
  • Environmental monitoring
  • Safe change filtration
  • UltraKlenz® HEPA H13/14 filters
  • Special U15 filters when required
  • Safety interlocks
  • KontrolKlenz automation with batch reporting
  • Special Air handlers (HVAC)
  • KlenzVap® biodecon
  • Related building automation
  • Special ducting and valves
  • Hermetic mouse-holes
  • Active mouse-holes
  • RTPs and appurtenances
  • Cycle Development & Cycle Validation (CD/CV)
  • H2O2 compliant protocols, implements, appurtenances and components
    Value adds:
  • CE/UL marking when specified
  • Third party HEPA filters on request
  • Duct wash downs (for potent applications)
  • Custom climatic control
  • Special docking methods
  • Custom configurations
  • New product developments
  • Sterilising tunnel interfaces
  • GAMP 5

Get in touch

O +91 22 6115 6215
E info@klenzaids.com

Klenzaids Contamination
Controls Pvt. Ltd.

A-21, M.I.D.C Industrial Area,
Street # 3, Andheri East.
Mumbai - 400 093, India.
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