PH PRESSES

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

SystemTechnologyPerformance
Servo-Driven Turret48 stations with 0.001mm precision±0.5% weight variation
AI Force ProfilingReal-time punch force adjustmentHardness CV ≤2%
PAT IntegrationNIR + Raman spectroscopyContent uniformity RSD ≤1.5%
Auto Tooling ChangeRFID-tagged punches & dies<3 min format change

2. cGMP-Centric Design

  • Containment Options:

    LevelOEB Threshold
    OEB40.1μg/m³ containment
    OEB50.01μg/m³ containment

  • Material Traceability:

    • Tooling lifecycle tracking

    • Granulation batch genealogy

3. Zero-Downtime Architecture

  • Quick-Release Components:

    ComponentChange Time
    Turret assembly<15 min
    Compression rolls<5 min

  • Redundant Systems:

    • Dual HMI control panels

    • Backup hydraulic pressure

Technical Specifications

ModelStandard PressPotent Compound PressBi-Layer Press
Max Output500,000 tabs/hr400,000 tabs/hr350,000 tabs/hr
Weight Accuracy±0.5%±0.3%±0.6%
Hardness Range50-500 N20-300 N50-400 N
Tooling Stations4836 (OEB5 containment)56 (dual feed)
Max Pressure100 kN80 kN120 kN
Power380V/50Hz, 22kW380V/50Hz, 18kW380V/50Hz, 30kW
Data Integrity21 CFR Part 11Same + audit trailSame
Footprint (L×W×H)2500×1800×2200mm2800×2000×2400mm3000×2200×2500mm

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:

ModuleFunction
In-line Disintegration TesterReal-time dissolution prediction
3D Vision InspectionChipping/capping detection (≥50μm)
AR Tooling SetupHoloLens-guided punch alignment
Carbon Neutral ModeEnergy-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

label: GMP Tablet Press Machine 500,000 Tabs/Hr ±0.5% Weight Control Pharma Grade Shanghai Guangzhi