PH PRESSES
High-speed pharmaceutical tablet press: 500k tabs/hr with ±0.5% weight accuracy. Real-time SPC, CIP/SIP & 21 CFR Part 11 compliance. Ideal for OSD manufacturing.
- Brand： glzon
- Model： GZM
Product Essence: Precision Engineered for Life-Critical Tablets
Shanghai Guangzhi PH-PRESS? Series delivers ±0.5% tablet weight uniformity at 500,000 tablets/hour – featuring AI-driven compression force control, in-line PAT sensors, and USP Class VI materials. Engineered for potent compounds, bi-layer tablets, and orodispersibles, it achieves >99.99% OEE while ensuring data integrity per FDA 21 CFR Part 11 and EU Annex 1 requirements.
Core Technology Innovations
1. Intelligent Compression Control
| System | Technology | Performance |
|---|---|---|
| Servo-Driven Turret | 48 stations with 0.001mm precision | ±0.5% weight variation |
| AI Force Profiling | Real-time punch force adjustment | Hardness CV ≤2% |
| PAT Integration | NIR + Raman spectroscopy | Content uniformity RSD ≤1.5% |
| Auto Tooling Change | RFID-tagged punches & dies | <3 min format change |
2. cGMP-Centric Design
Containment Options:
Level OEB Threshold OEB4 0.1μg/m3 containment OEB5 0.01μg/m3 containment Material Traceability:
Tooling lifecycle tracking
Granulation batch genealogy
3. Zero-Downtime Architecture
Quick-Release Components:
Component Change Time Turret assembly <15 min Compression rolls <5 min Redundant Systems:
Dual HMI control panels
Backup hydraulic pressure
Technical Specifications
| Model | Standard Press | Potent Compound Press | Bi-Layer Press |
|---|---|---|---|
| Max Output | 500,000 tabs/hr | 400,000 tabs/hr | 350,000 tabs/hr |
| Weight Accuracy | ±0.5% | ±0.3% | ±0.6% |
| Hardness Range | 50-500 N | 20-300 N | 50-400 N |
| Tooling Stations | 48 | 36 (OEB5 containment) | 56 (dual feed) |
| Max Pressure | 100 kN | 80 kN | 120 kN |
| Power | 380V/50Hz, 22kW | 380V/50Hz, 18kW | 380V/50Hz, 30kW |
| Data Integrity | 21 CFR Part 11 | Same + audit trail | Same |
| Footprint (L×W×H) | 2500×1800×2200mm | 2800×2000×2400mm | 3000×2200×2500mm |
Tablet-Specific Engineering
Standard Tablets
Auto-dust extraction system
Magnetic metal detection
Orodispersibles (ODTs)
Low-force compression (20-80 N)
Humidity control <30% RH
Bi-Layer/Multi-Layer
Dual gravimetric feeders
Layer thickness control ±0.05mm
Potent Compounds
Glovebox integration
Continuous air monitoring
Smart Control Ecosystem
10" HMI with PAT Dashboard
Critical Modules:
SPC Analytics:
Cp/Cpk for weight/hardness/thickness
Trend prediction with control limits
Predictive Maintenance:
Punch wear index
Turret bearing health
Digital Twin:
Virtual FAT/commissioning
Operational Impact
Top 10 Pharma Company Validation:
Challenge: 0.8% RSD in high-potency API tablets
Solution: PH-PRESS? with OEB5 containment + PAT
Results:
? 0.5% RSD content uniformity
? Zero cross-contamination
? ROI in 14 months via reduced QC testing
Certifications & Upgrades
Global Compliance:
FDA 21 CFR Part 211
EU GMP Annex 1
ISO 13485:2016
PIC/S GMP Guide
Advanced Modules:
| Module | Function |
|---|---|
| In-line Disintegration Tester | Real-time dissolution prediction |
| 3D Vision Inspection | Chipping/capping detection (≥50μm) |
| AR Tooling Setup | HoloLens-guided punch alignment |
| Carbon Neutral Mode | Energy-saving algorithm (30% reduction) |
Support & Service
24/7 Pharma Support Network:
Remote diagnostics via validated VPN
Critical Spares Dispatch ≤48h:
Compression rolls
PAT sensors
RFID tooling
Performance Validation:
USP <1062> content uniformity testing
GMP IQ/OQ/PQ protocols