Challenges
Containment Breach During Spray Nozzle Adjustment
Nozzle maintenance mid-process requires contained access — standard glove ports insufficient reach.
Negative Pressure Loss During Discharge Valve Opening
Discharge valve opening disrupts differential pressure — momentary containment breach.
CIP Validation Under Fully Contained Conditions
TOC swab testing of bowl interior through glove ports only — limited sampling coverage.
Blind Torque Endpoint Without Direct Sampling
Traditional sampling not possible — torque endpoint required with high process confidence.
Gauntlet Fatigue During Extended Granulation Campaigns
Repeated glove-port operation over multi-batch shifts risks integrity and fatigue.
Solutions
- Extended Reach Glove-Port Arm (600 mm vs. Standard 350 mm): Extended arm provides full bowl interior access including spray nozzle tips.
- Active Pressure-Compensation During Discharge (LEV Auto-Boost 30 s): LEV increases extract during discharge to compensate valve opening — ΔP maintained.
- CIP-in-Place with UV Dye + Camera Inspection Validation: UV dye test documents 100% coverage through glove-port camera — regulatory accepted.
- NIR In-Process Monitoring (Through-Window Probe, No Sampling): NIR probe through bowl wall continuously monitors granule moisture and endpoint.
- Gauntlet Integrity Testing Every 2 Hours (Pressure-Test Protocol): Scheduled 1.5 bar integrity test every 2 hours — early breach detection before failure.
Applications
- Pharmaceutical (Cytotoxic): Oncology API granulation — OEB 5 (<1 µg/m³) validated containment throughout.
- Pharmaceutical (Hormonal): Hormonal and endocrine API granulation with strict operator protection.
- Pharmaceutical (Potent): OEB 4 (<10 µg/m³) potent compound granulation with SBV and contained discharge.
- Biotechnology: High-potency biologic intermediate granulation in contained GMP environment.
- Research & Development: Small-scale (<25 L) HPAPI granulation trial with full OEB 5 containment.
Models & Capacities
1C. Contained HPAPI RMG — Models & Capacities | ||||||||||
Model | Net Vol. [L] | Batch Size [kg] | Containment OEB Level | Neg. Pressure [Pa] | Impeller Motor [kW] | Glove Ports | Bowl Ø [mm] | Bowl H [mm] | Overall H [mm] | System Wt. [kg] |
RMG-HP-025 | 25 | 8–15 | OEB 4–5 | −30 to −50 | 5.5 | 2 | 550 | 430 | 2,500 | 1,800 |
RMG-HP-060 | 60 | 18–36 | OEB 4–5 | −30 to −50 | 11 | 2 | 750 | 580 | 3,500 | 3,200 |
RMG-HP-150 | 150 | 45–90 | OEB 4–5 | −30 to −50 | 18.5 | 2 | 1,000 | 780 | 4,800 | 5,800 |
RMG-HP-300 | 300 | 90–180 | OEB 4–5 | −30 to −50 | 30 | 4 | 1,300 | 980 | 6,200 | 9,500 |
RMG-HP-600 | 600 | 180–360 | OEB 4–5 | −30 to −50 | 55 | 4 | 1,600 | 1,200 | 7,800 | 15,000 |