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SKAN pure²
Efficient laboratory isolator for safe, aseptic, and toxic applications with flexible, space-saving design
The pure² isolator provides reliable protection for aseptic and aseptic-toxic processes. With enclosed containment and rapid H₂O₂ decontamination via the patented skanfog® technology, it ensures both safety and efficiency. Its modular design, easy installation, and integrated exhaust air treatment make it a flexible “plug-and-play” solution.
This isolator provides enclosed containment that meets all cleanroom standards. Achieving GMP Grade A and ISO 5 (ISO 14644), it creates a stable, validated environment for aseptic and aseptic-toxic processes
Flexible operating modes and modular construction make the pure² isolator suitable for a variety of applications – from research and development to production. It can also be used for manual and semi-automated applications in formulation and aseptic handling.
Patented skanfog technology enables an automated and reproducible H2O2 decontamination cycle, reducing setup times, speeding processes, and ensuring the highest microbiological safety.
Thoughtful design and spacious work areas provide optimal ergonomics and comfortable working conditions. Combined with high safety standards, the isolator contributes to sustainable productivity in daily laboratory operations.
The SKAN pure² isolator has been developed for the safe handling of highly potent active substances such as cytostatic drugs and other CMR medicines, and offers maximum protection for both the product and personnel. The system can be qualified in accordance with the requirements of DIN 12980, including the SMEPAC containment test, and is suitable for applications with containment requirements up to OEB 6.
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- ATMPs
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- Quality control
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- Research
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- Hospital & Pharmacy
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- Modular configuration
- Robust stainless steel construction: Work area and material airlock made of stainless steel – durable, hygienic, and corrosion-resistant.
- Quick implementation: Standardisation and pre-production reduce delivery and project times
- Modular design: Modular construction with chambers that can be flexibly combined to suit different processes
- Safe cleanroom class: Complies with GMP cleanroom Grade A and ISO 5 for sensitive and regulated applications
- Modern control system: Siemens S7-1500 with 9″ display, GMP package, and local user management
- Validated software: Control and software compliant with GAMP 5 Category 4 ensuring maximum regulatory security
- Regulatory-compliant documentation: Batch records and audit trails compliant with FDA 21 CFR Part 11, as well as integration with LIMS, EMS or MES systems.
- Maintenance-friendly design: All openings accessible from the front, ideal for wall mounting and efficient servicing
England