SKAN's pure² isolator for laboratory and hospital processes
Standard
CFR 21 Part 11
Standard
DIN 12980
Containment
OEB 6
ISO class
ISO 5
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.
Work area and material airlock made of stainless steel – durable, hygienic, and corrosion-resistant.
Standardisation and pre-production reduce delivery and project times
Modular construction with chambers that can be flexibly combined to suit different processes
Complies with GMP cleanroom Grade A and ISO 5 for sensitive and regulated applications
Siemens S7-1500 with 9″ display, GMP package, and local user management
Control and software compliant with GAMP 5 Category 4 ensuring maximum regulatory security
Batch records and audit trails compliant with FDA 21 CFR Part 11, as well as integration with LIMS, EMS or MES systems.
All openings accessible from the front, ideal for wall mounting and efficient servicing
The pure² 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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The long-standing collaboration and successful projects with TU Dresden strengthened the idea of jointly developing a new modular solution specifically tailored to the requirements of gene and cell therapy applications.
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“Bring your innovation to its destination.” This is the guiding principle that Solvias follows every day.
Read more2811 x 955 x 2277
2196 x 955 x 2277
1581 x 955 x 2277
1410 x 715 x 629
-60 oder +60 Pa (to be defined)
220 – 240 VAC / 50 – 60 Hz / max. 3500 W
3301 x955 x 2277
2683 x 955 x 2277
2065 x 955 x 2277
1985 x 715 x 629
-60 oder +60 Pa (to be defined)
220 – 240 VAC / 50 – 60 Hz / max. 3800 W
