OverviewThe GTC III is an integrated granulation line engineered for contained handling of highly potent active pharmaceutical ingredients (HPAPIs). Designed to OEB 5 containment standards, the system delivers a continuous granulation workflow from wet granulation through milling to final blending, with options for contained material transfer and in‑isolator weighing.
Features & benefitsComplete OEB 5 granulation line | Enables granulation through blending under high containment for HPAPIs
Rapid transfer port, active transfer port, contained poly bag transfer | Supports safe, integrity-preserving material transfers into isolators
Capacity range 1.5–10 L | Adapts to small-scale R&D and clinical batch requirements
Integrated wet and dry mills | Enables contained particle sizing across wet and dry stages
Multiple glove ports and in‑isolator scale option | Ensures operator access and closed‑system weighing where required
IPC control with 21 CFR Part 11 compliance | Provides audit trails, user/recipe management and batch reporting
Strategically placed washing nozzles and handheld options | Facilitates efficient contained cleaning
Optimised footprint | Reduces facility space requirements and eases integration
Key features (list)- OEB 5 containment design for HPAPI processing
- Integrated wet and dry milling for contained particle sizing
- Rapid transfer port, active transfer port and contained poly bag transfer options
- Multiple glove ports for operator access inside the isolator
- Option to integrate weighing scale inside the isolator
- Online interface for binder spray rate monitoring
- IPC-based control with 21 CFR Part 11 compliance (audit trails, user/recipe management, batch reports)
- Fixed and handheld washing nozzles for contained cleaning
- Bowl/capacities covering 1.5 to 10 L
- Compact, optimised footprint for facility efficiency
Technical specifications- Containment level: OEB 5 compliant
- Intended application: granulation of oncological, hormonal, biopharmaceutical, antiviral and other HPAPIs
- Batch capacity range: 1.5 L to 10 L
- Process flow: integrated granulation train from wet granulation to blending
- Mills: integrated wet and dry mills for contained particle sizing
- Material transfer options: rapid transfer port (RTP), active transfer port (ATP), contained poly bag transfer
- Operator access: multiple glove ports; option to place weighing scale inside isolator
- Control system: IPC-based control with 21 CFR Part 11 compliance (audit trails, user/recipe management, batch reports)
- Cleaning: strategically placed fixed and handheld washing nozzles
- Monitoring: online interface for binder spray rate control
- Design focus: containment, operator safety, product integrity, environmental protection, optimised footprint