** The pure² Isolator requires configuration before it can be quoted to meet your specific needs. Please use our pure² Isolator form to answer a brief questionnaire so we can get started on assisting you! **
The pure² Isolator with 2-Ports or 4-Ports and a Left Airlock (230V) is designed for safe and efficient processing in ISO Class 5 conditions. It features advanced HEPA filtration, H2O2 decontamination, and ergonomic access.
- additional compenents included: Left Airlock, 2 (or 4) Glove Port Main Chamber, H2O2 Station with Storage, SKANPURE Spray Nozzles, Cloud Dosing System, HEPA Filters, Pneumatic Air Supply System
- additional components required: Hydrogen Peroxide, Compressed Air Supply, TLV Sensor for H2O2, Uniterupted Power Supply
The pure2 Isolator IQ/OQ Qualification document has comprehensive Installation Qualification (IQ) and Operational Qualification (OQ) protocols. It includes testing procedures, documentation requirements, and criteria to meet standards.
Cycle Microbiological Qualification (MBQ). Includes onsite microbiological qualification per SKAN SOP for H2O2 decontamination cycles with BIs, aeration confirmation, residual detection, and full reporting. Requires isolator in defined conditions. (additional components required: 2.5L bottle of H2O2 (Solvay Brand), Incubation Capacity (55C-60C), Refrigerator (2C-8C), Nutritional Media (TSB))
- additional compenents included: Final report on microbiological qualification, Biological Indicators (BI)
- additional components required: 2.5L bottle of H2O2 (Solvay Brand), Incubation Capacity (55C-60C), Refrigerator (2C-8C), Nutritional Media (TSB)