Full Isolator Solid Dosage Production line for OEB5 High Potent Product
For Granulator/HSM/Fluid Bed Dryer/Mill/Blender/Tablet Press/Capsule Fill/Coater/Blister and etc.
Features
- ✓Fully Customized for Different OSD Machines
- ✓Mockup for Ergonomic design.
- ✓Leakage rate ≤0.25 VOL%/Hr (Comply OEB4-5) As Per ISO 10648-2/ISO 14644-7/PDA TR34/AGS Guide line
- ✓Turbulent Air Flow, EBM Fan. Air exchange rate≥20ACH
- ✓Push-Push Filter or BIBO Filter Camfil H14
- ✓WIP Spray Gun，CIP Spray Ball , Drain with Catch Pot.
- ✓RTP/Continuous Liner System for Waste Discharge
- ✓SIEMENS PLC and IPC Control System
- ✓Comply with FDA 21CFR PART11.Audit Trail. Electrical Signature and Electrical Record. Batch Report. Log Report. Alarm Report. Recipe control. Data back. Remote Diagnosis. SCADA System
- ✓Explosion Proof Design
- ✓On-site SMEPAC Test certified by CIH inspector and AIHA Lab!