en
SKAN pure²
Efficient laboratory isolator for safe, aseptic, and toxic applications with flexible, space-saving design
The SKAN pure² isolator provides reliable product and personnel protection for aseptic and aseptic-toxic processes. Closed containment and rapid H₂O₂ decontamination using patented skanfog® technology combine safety and efficiency within a flexible, space-saving system.
The pure² provides a stable, validated working environment that achieves GMP Grade A and ISO Class 5 in accordance with ISO 14644. Designed to support aseptic processing in line with EU GMP Annex 1, the isolator uses closed containment to minimise the risk of contamination. Integrated exhaust air treatment supports the safe handling of hazardous substances, while its modular construction and straightforward installation make it a practical plug-and-play solution.
Flexible operating modes allow the pure² to support a variety of applications, from research and development through to production. The isolator is suitable for manual and semi-automated applications, including formulation and aseptic handling.
Patented skanfog® technology provides automated and reproducible H₂O₂ decontamination cycles. Rapid cycle times help to reduce setup times and improve process efficiency while maintaining a high level of microbiological safety.
Spacious work areas and an ergonomic design provide comfortable working conditions for routine laboratory operations. Combined with high safety standards, these features help to support efficient and reliable day-to-day working.
The SKAN pure² has been developed for the safe handling of highly potent active substances, including cytotoxic drugs and other carcinogenic, mutagenic or reprotoxic (CMR) medicines. It provides a high level of protection for both the product and personnel during each aseptic-toxic process.
The system can be qualified in accordance with DIN 12980 requirements, including SMEPAC containment testing, and is suitable for applications with containment requirements up to OEB 6.
Applications include advanced therapy medicinal products (ATMPs), quality control, research, hospital and pharmacy processes, sterility testing, and cell and gene therapy.
- 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
