Schematic Industries are specialists at manufacturing bespoke, client specific Barrier Isolator systems to cGMP and cGAMP standards. We manufacture both Rigid and Flexible Isolator systems with negative pressurised internal environments and Rigid Isolators with positive pressurised internal environments.
Our positive (+ve) barrier isolators are essential where possible external contamination from the clean-room environment or personnel can not be allowed to enter the process media.
These positive isolators are generally more complex than our negative range and controlled by PLC or HMI control panel. During automatic operation, the barrier isolator goes through its start-up sequence ensuring all checks are completed. It then conducts a decontamination operation by VHP and once successfully performed it auto switches to show an 'isolator healthy' operation ready for processing.
These systems are commonly used for Sterility applications in the pharmaceutical sector, as discussed below.
- Rugged 316 Stainless Steel build with fully welded, large radius and polished corners
- Flat type safe changeable HEPA filters on inlet and outlet vents (push-push filters are optional)
- cGAMP - PLC/HMI controlled - Digital pressure controller or Electrical controller to maintain a constant pressure
- Integrated Clean In Place / washable to reach every corner of chamber
- Integrated Weighing Scale and Continuous liner port
- CG screen to ensure Laminar airflow
- Oxygen monitoring / Nitrogen inertization
- Complete Documentation – FDS, DQ, FAT, IQ, OQ, OMM, Leak test, Lux, Noise, Air change, Filter integrity, Glove test and OEL
- Integration with RTP for safe and rapid transfer
- Multiple or Single Chambers
- Separate air handling unit for main chamber and pass box
- Isolator raise/lower systems for operator comfort
- Disinfection or decontamination by VHP ( Vapourised Hydrogen Peroxide) cycle. Designed with rapid release of VHP after decontamination
- Record and retrieve the isolator operation data.
- Multilevel password protection for Isolator operation, maintenance and control
- Minimum air changes 10
- Excellent lux operator lighting conditions.