Products

Requirements

  • Cost effective Grade A, ISO 5 containment that eliminates full cleanroom requirements
  • Wide application range
  • Fast and automated decontamination cycles by H2O2
  • Excellent ergonomics and working conditions
  • Compliance to current regulatory and standards requirements

Standards & Certifications

  • CB-Scheme according to IEC 61010-1:2010 that complies to international mutual accepted IECEE-standards of product safety for electrical devices. Tested, certified and controlled by accredited testing laboratory Eurofins Product Service GmbH.
  • GS-Mark according to standard DIN 12980:2017-05 that complies to German Product Safety Act (ProdSG§22). Tested, certified and controlled by accredited testing laboratory TÜV NORD CERT GmbH.
  • Machinery Directive 2006/42/EC
  • EMC Directive 2014/30/EC
  • EN 12469 (performance criteria for microbiological safety cabinets)
  • ISO 14644-7 (clean air hoods, gloveboxes, isolators, mini-environments)
  • Solution
    • SKAN pure: An aseptic and aseptic-toxic working isolator
    • Closed containment provides a safe handling condition also when working with high potent products
    • Fast and safe H2O2 decontamination cycles with the patented skanfog® technology
    • Large and fast airlock to improve isolator productivity
    • No connection to HVAC required due to integrated SKAN nanox® catalyst system
    • Easy to install “plug and play” solution
    • Modular, space saving design
    • A worldwide reputable service and after-sales support through our branch offices or partners
  • Functional principle

    SKAN combines extensive knowledge of laboratory workbenches and isolator technoloy. The SKAN pure isolator is built, tested and certified according to the standards and regulations for isolators for the production of cytostatics and for closed microbiological workbenches. skanfog® technology guarantees a fast, reproducible and validatable decontamination cycle. The patented SKAN nanox® catalyst technology reduces the aeration time and allows autonomous operation, without connection to the building exhaust air.

  • Characteristics
    • Working chamber and airlock in stainless steel
    • Smooth and easy to clean working surface
    • Selectable positive or negative pressure operation
    • Maintains cGMP cleanroom Class A, ISO 5 standards
    • User-friendly 10“ color touch screen control panel
    • Mainboard and software engineered according GAMP 5
    • Batch reporting
    • All working and maintenance openings are accessible from the front, ideal for wall installation
    • Easy assembly, installation and access through standard doorways and elevators
  • Field of application
    • Carcinogenic, mutagenic or reprotoxic substances (CMR)
    • Total parenteral nutrition (TPN)
    • Intravenous solution (IV)
    • Cytotoxic
    • Virostatic
    • Anti-neoplastic chemotherapy
    • Pathogenic microbiology / viruses
    • Transformed DNA
    • Small scale aseptic pharma production
    • Cell cultures
    • Quality control
    • Cell therapy
  • Additional products and options
    • Two working chamber sizes available, either with two or four glove ports.
    • The airlock with a shelf is available on the right, on the left or on both sides of the isolator.
    • SKAN pure can be equipped with an additional glove testing system.
  • Distribution partner

SKAN Pure Solutions

Technical specification

Technical Data2 gloves (chamber + 2 airlocks)4 gloves (chamber + 2 airlocks)
Outer dimensions (W x D x H)2811 x 955 x 2277 mm3300 x 955 x 2277 mm
Inside dimensions, working space (W x D x H)1410 x 715 x 629 mm1895 x 715 x 629 mm
Operation pressure-60 or +60 Pa (to define when ordering)-60 or +60 Pa (to define when ordering)
Power supply (single phase)220 – 240 VAC / 50 – 60 Hz / max. 3800 W220 – 240 VAC / 50 – 60 Hz / max. 3800 W


Related services