Klenzaids

Isolators

Isolators

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