SKAN pure² Isolator - 2-glove working chamber

Requirements

• Safe containment that satisfies all cleanroomrequirements (cGMP class A/ISO class 5 in accordance with ISO 14644)
• Wide range of applications
• Fast and automated H2O2 decontamination
• Excellent ergonomics and working conditions combined with maximum safety
• Compliance with applicable regulatory and standardised requirements

Standards & Certifications

In accordance with Machinery Directive 2006/42/EC, EMC Directive 2014/30/EC, DIN EN 12469, DIN 12980, ISO 14644-7, cTUVus certified

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

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.

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
• Electronic batch recording
• 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.