pure²

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

• Solution
  • SKAN pure²: 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 pure² 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 GMP cleanroom Class A, ISO 5 standards
  • User-friendly Siemens P7-1500 with 9“ color touch screen control panel
  • Mainboard and software engineered according GAMP 5
  • Batch reporting in pdf documents, FDA 21 CFR Part 11 compliant
  • 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
  • Cell & Gene:
    • Cell therapy
    • Cell cultures
    • Transformed DNA
  • Sterility testing:
    • Quality control
  • Pharmaceutical manufacture
    • Carcinogenic, mutagenic or reprotoxic substances (CMR)
    • Total parenteral nutrition (TPN)
    • Intravenous solution (IV)
    • Cytotoxic
    • Virostatic
    • Anti-neoplastic chemotherapy
    • Transformed DNA
    • Small scale aseptic pharma production
  • Biosafety:
    • Pathogenic microbiology / viruses
    • Transformed DNA
• 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 pure² can be equipped with an additional glove testing system.
• Distribution partner

  For detailed information, please contact our partners:

  • Austria
  • Belgium
  • Bosnia-Herzegovina
  • Denmark
  • Finland
  • Germany (Berner)
  • Germany (LMS consult)
  • Hungary
  • Latvia
  • Japan
  • Lithuania
  • Norway
  • Serbia 
  • Slovenia
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom
  • USA
  • Aseptic Technologies, for special fill and finish unit

   

  All other countries upon request: vk-lab@skan.ch

Downloads