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RTC-Refine
Synthesis and Refine Process Module

Module Overview

Integrated with three core processes—synthesis reaction, crystallization/purification, and filtration-washing-drying (JTNB)—this system achieves continuous, closed production from raw material feeding to finished product packaging through fully automated control and closed-loop optimization of process parameters. Compliant with cGMP, ICH Q7, and ATEX explosion-proof certifications, it is designed for large-scale manufacturing of high-risk reactions and high-purity products.

Core Components

Key Process Control Points

Synthesis Reaction: Temperature/Pressure & Precision Control

● Temperature range: -50°C to 300°C (PID control ±0.5°C)

● High-pressure reactors (≤10MPa) with real-time pressure monitoring and emergency pressure relief interlock

● High-precision metering pumps (±0.5% accuracy) paired with mass flow meters for stoichiometric stability

● Gradient feeding strategies (e.g., dropwise addition, pulse injection) to prevent localized overheating and side reactions

Crystallization: Supersaturation & Particle Size Distribution Control

● Real-time supersaturation adjustment via online Raman spectroscopy/turbidity sensors; automated cooling rate control (0.1–5°C/min)

● Particle size management: Online laser particle size analyzer (0.1–1000μm) linked to agitator speed for crystal growth tuning

Filtration-Washing-Drying (JTNB-ANFD): Cake & Drying Efficiency

● Filter cake thickness (10–200mm adjustable) and multi-stage countercurrent washing (40% reduction in solvent usage)

● Drying endpoint determination via NIR moisture sensor (final moisture ≤0.5%)

● Inert gas circulation (N?/Ar) for heat-sensitive materials

Safety & Environmental Compliance

● ATEX Zone 1/GB explosion-proof certification; online combustible gas monitoring

● Data integrity per 21 CFR Part 11 (electronic batch records), full audit trails for all parameters (temperature, pressure, pH, etc.)

Industry Applications

Pharmaceutical APIs

Antibiotic crystallization, asymmetric synthesis of chiral compounds, solid-phase peptide synthesis

Fine Chemicals

Noble metal catalyst preparation, LCD monomer purification, photoresist resin synthesis

Advanced Materials

Hydrothermal synthesis of MOFs, lithium battery cathode material washing/drying, nanoparticle size control

Core Advantages

High Efficiency & Precision

-Continuous-flow synthesis reduces batch cycle time by 50%; crystal size CV ≤5%

-Automatic parameter deviation compensation boosts yield by 15–20%

Flexibility & Scalability

-Modular design enables seamless scale-up from lab to ton-scale production

-Rapid product changeover (CIP/SIP ≤2 hours)

Energy & Cost Savings

-Heat cascade utilization (reaction waste heat for drying) cuts energy use by 30%

-Solvent recovery rate ≥98%; waste reduction ≥60%

Service Support

Full validation package

FDA/GMP/OSHA compliance with DQ/IQ/OQ/PQ/FAT documentation

Lifecycle management

Remote O&M, smart spare parts scheduling, continuous process optimization, IoT-enabled predictive maintenance

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