Sterile Processing Systems

Sterile Processing Systems - Milkaya | Pharmaceutical Manufacturing Equipment

Sterile Processing Systems

Advanced pharmaceutical sterile processing equipment with aseptic manufacturing capabilities, sterile filtration systems, and FDA/GMP compliant contamination control for superior drug production quality

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Complete Sterile Processing Equipment Range

From aseptic manufacturing to sterile filtration, our comprehensive sterile processing systems ensure pharmaceutical product safety, purity, and regulatory compliance

Aseptic Processing Lines

State-of-the-art aseptic processing systems with sterile product handling, closed-loop design, and integrated contamination control for pharmaceutical manufacturing requiring sterile conditions throughout production.

  • Closed-loop aseptic systems
  • Sterile product handling
  • Integrated barrier systems
  • Environmental monitoring
  • Automated CIP/SIP systems
  • Process validation support

Technical Specifications

Sterility Level SAL 10⁻⁶
Pressure +15-25 Pa
Capacity 50-5000 L/h
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Sterile Filtration Systems

Advanced sterile filtration equipment with HEPA/ULPA filters, membrane filtration, and multi-stage purification systems for removing microorganisms and particles from pharmaceutical products and process media.

  • 0.22µm membrane filters
  • HEPA/ULPA filtration
  • Multi-stage purification
  • Integrity testing systems
  • Steam sterilization capability
  • Automated filter changes

Technical Specifications

Filtration 0.1-0.22µm
Efficiency 99.99%
Flow Rate 10-1000 L/h
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Sterilization Equipment

Comprehensive sterilization systems including autoclaves, dry heat sterilizers, and hydrogen peroxide vaporizers for equipment, media, and facility decontamination with validation documentation.

  • Steam sterilization autoclaves
  • Dry heat sterilizers
  • VHP decontamination
  • Gamma irradiation systems
  • Validation documentation
  • Temperature mapping

Technical Specifications

Temperature 121-134°C
Pressure 1-3 bar
Cycle Time 15-60 min
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Pharmaceutical Isolators

Advanced pharmaceutical isolator systems with positive/negative pressure control, integrated glove systems, and decontamination capabilities for high-containment sterile processing and operator protection.

  • Positive/negative pressure
  • Integrated glove systems
  • VHP decontamination
  • HEPA filtration
  • Material transfer systems
  • Continuous monitoring

Technical Specifications

Pressure ±50-250 Pa
Air Changes 20-40 ACH
ISO Class 3-5
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CIP/SIP Systems

Automated cleaning-in-place and sterilization-in-place systems with programmable cycles, chemical dosing, and validation recording for maintaining sterile processing equipment without disassembly.

  • Automated CIP cycles
  • Steam-in-place systems
  • Chemical dosing control
  • Temperature monitoring
  • Validation recording
  • Recipe management

Technical Specifications

Temperature 65-95°C
Flow Rate 5-50 m³/h
Conductivity 1-50 µS/cm
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Water for Injection (WFI) Systems

Complete water for injection generation and distribution systems with multi-effect distillation, reverse osmosis, and continuous circulation for pharmaceutical grade water production and delivery.

  • Multi-effect distillation
  • Reverse osmosis pretreatment
  • Hot water sanitization
  • Continuous circulation
  • Online monitoring
  • USP/EP compliance

Technical Specifications

Capacity 500-5000 L/h
Conductivity ≤1.3 µS/cm
Endotoxins ≤0.25 EU/mL
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Sterile Processing Workflow

Our integrated sterile processing systems ensure complete contamination control and sterility assurance from raw materials to final pharmaceutical products

Media Preparation

Sterile media and solution preparation with WFI systems and sterile filtration

Contamination Control

Multi-barrier contamination control with isolators, HEPA filtration, and environmental monitoring

Aseptic Processing

Sterile manufacturing with closed-loop systems and continuous sterility monitoring

Sterile Filtration

Final sterile filtration through 0.22µm membranes with integrity testing

Aseptic Fill/Finish

Sterile filling and packaging in controlled environments with leak testing

Quality Assurance

Comprehensive sterility testing, validation, and regulatory documentation

Ready to Implement Sterile Processing Excellence?

Get expert consultation on FDA/GMP compliant sterile processing systems and discover how Milkaya's advanced equipment can ensure pharmaceutical product safety and regulatory compliance.

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