API Manufacturing Systems

API Manufacturing Systems - Milkaya | Active Pharmaceutical Ingredient Production Equipment

API Manufacturing Systems

Complete Active Pharmaceutical Ingredient manufacturing solutions with chemical synthesis reactors, crystallization equipment, purification systems, and FDA/GMP compliant processing technologies for high-purity pharmaceutical compounds

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Complete API Manufacturing Equipment Solutions

From chemical synthesis to final purification, our comprehensive API manufacturing systems ensure pharmaceutical-grade compound production with maximum purity and regulatory compliance

Chemical Synthesis Reactors

Advanced multi-purpose glass-lined and stainless steel reactors with precise temperature control, agitation systems, and inert atmosphere capabilities for complex pharmaceutical synthesis reactions and API production.

  • Glass-lined steel reactors
  • Multi-purpose synthesis vessels
  • Temperature control systems
  • Agitation and mixing systems
  • Inert atmosphere control
  • Pressure and vacuum operations

Technical Specifications

Volume 50L - 20,000L
Temperature -20°C to +300°C
Pressure Full Vacuum to 25 bar
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Crystallization & Precipitation Systems

Precision crystallization equipment with controlled cooling, seeding, and agitation for optimal crystal formation, particle size distribution, and API purity with automated process control and monitoring.

  • Controlled cooling crystallizers
  • Evaporative crystallization
  • Seeding and nucleation control
  • Crystal size distribution
  • Automated process control
  • In-line monitoring systems

Technical Specifications

Capacity 100L - 10,000L
Cooling Rate 0.1-5°C/min
Purity 99.5%+
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Purification & Separation Systems

Advanced purification technologies including column chromatography, membrane separation, and distillation systems for removing impurities and achieving pharmaceutical-grade API purity standards.

  • Column chromatography systems
  • Membrane separation technology
  • Distillation and rectification
  • Extraction columns
  • Activated carbon treatment
  • Multi-stage purification

Technical Specifications

Purity Level 99.9%+
Recovery 95-98%
Capacity 50-5000 kg/batch
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API Drying & Finishing Systems

Specialized drying equipment including vacuum dryers, fluid bed dryers, and spray dryers with controlled atmosphere and temperature for optimal API moisture content and stability.

  • Vacuum tray dryers
  • Fluid bed drying systems
  • Spray drying technology
  • Freeze drying capability
  • Controlled atmosphere drying
  • Solvent recovery systems

Technical Specifications

Temperature 20-150°C
Moisture ≤0.5% final
Batch Size 10-1000 kg
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Distillation & Rectification Columns

High-efficiency distillation columns with structured packing, automatic reflux control, and precise separation capabilities for solvent recovery and API purification in pharmaceutical manufacturing.

  • Structured packing columns
  • Automatic reflux control
  • Multi-component separation
  • Solvent recovery systems
  • Vacuum distillation capability
  • Temperature and pressure monitoring

Technical Specifications

Efficiency 95-99%
Reflux Ratio 0.5-10:1
Throughput 100-10,000 L/h
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Extraction & Leaching Systems

Advanced extraction equipment including liquid-liquid extraction, supercritical fluid extraction, and solid-liquid extraction systems for API isolation and purification from natural and synthetic sources.

  • Liquid-liquid extraction
  • Supercritical CO2 extraction
  • Solid-liquid extraction
  • Counter-current extraction
  • Solvent extraction systems
  • Automated extraction control

Technical Specifications

Extraction Rate 90-98%
Pressure 1-300 bar
Temperature -10°C to +200°C
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Process Control & Automation

Comprehensive process control systems with SCADA, DCS integration, real-time monitoring, and automated batch control for consistent API quality, regulatory compliance, and production optimization.

  • SCADA control systems
  • DCS integration
  • Real-time process monitoring
  • Automated batch control
  • Quality control integration
  • Regulatory compliance tracking

Technical Specifications

Response Time ≤1 second
Accuracy ±0.1%
Data Logging 21 CFR Part 11
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Integrated Quality Control Systems

In-line and at-line analytical systems including HPLC, GC, spectroscopy, and particle size analyzers for real-time API quality monitoring and batch release documentation.

  • In-line HPLC systems
  • GC analysis integration
  • NIR spectroscopy
  • Particle size analysis
  • Moisture content monitoring
  • Automated sampling systems

Technical Specifications

Detection Limit ppm level
Analysis Time 5-30 minutes
Precision RSD ≤2%
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API Manufacturing Process Flow

Our integrated API manufacturing systems ensure complete process control from raw materials to pharmaceutical-grade active ingredients with maximum purity and compliance

Chemical Synthesis

Multi-step synthesis reactions in controlled reactors with precise temperature, pressure, and atmosphere control

Purification & Separation

Advanced purification using chromatography, distillation, and membrane separation for impurity removal

Crystallization

Controlled crystallization processes for optimal particle size distribution and API purity

Drying & Finishing

Specialized drying systems with controlled atmosphere for optimal moisture content and stability

Quality Testing

Comprehensive analytical testing including purity, potency, and impurity analysis for batch release

Packaging & Storage

Controlled packaging and storage in appropriate containers with stability and shelf-life documentation

Ready to Build Your API Manufacturing Facility?

Get expert consultation on FDA/GMP compliant API manufacturing systems and discover how Milkaya's advanced processing technologies can ensure pharmaceutical-grade compound production excellence.

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