Microniser Isolator Hybrid
Schematic supplied the microniser shown below in September 2016.
It was supplied with several chambers internally coated in Stancoat; a hard wearing, highly chemical resistant surface coating to increase the operating performance of the 316 L stainless steel rigid isolator.
Isolator Design Features
Design Features
- Rugged 316 Stainless Steel build with fully welded, large radius and polished corners
- Push-push type safe changeable HEPA filters on inlet and outlet vents
- 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, Nutsche Filter, Vacuum Tray Dryer, Continuous liner port and Drum loader
- 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
- Split Butterfly valve for safe transfer of material
- Multiple or Single Chambers
- Isolator raise/lower systems for operator comfort
Operational Benefits
Operational Benefits
- Stable and accurate results
- Clear visibility during operation and cleaning
- Operator safety - fully interlocked air-locks, doors and visors
- Uncontaminated process media
- cGAMP - Alarms and safety measures in case of breach
Technical Specification
Technical Specification
- ISO 14644-1: class ISO 5 (Class 100, Grade A)
- Integral Micronizer - size selected for customer process requirements
- Containment breach alarm
- Low pressure and high pressure alarm
- Filter choked alarm
- Interlocked door system
- HEPA Filters
- Supplied to OEL Categories OEL 1-5 (see Table)
- Light Vacuum (100 Pa) system
- Transfer System designs to suit application (optional)
- Manual drum tippers (Automatic optional)
OEL Hazards
OEL Hazards
Industry standard OEL hazard categories and descriptions are shown below. Schematic can supply Barrier Isolators to all OEL categories shown.
OEL 1 - Harmful and / or low pharmacological activity
OEL 2 - Harmful and / or moderate pharmacological activity
OEL 3 - Moderately toxic and / or high pharmacological activity
OEL 4 - Toxic and / or very high pharmacological activity
OEL 5 - Extremely toxic and / or extremely high pharmacological activity
Schematic has designed, manufactured and commissioned many innovative Microniser Barrier Isolator systems. 