Pharma separator for aseptic biopharma processing

Achieve precise separation and concentration of sensitive biopharmaceutical components, including vaccines and monoclonal antibodies, while ensuring seamless integration into your aseptic processing line.

Separates and Clarifies Biopharmaceutical Products

The GEA Pharma Separator Aseptic X offers cutting-edge separation technology for biopharmaceutical processing, designed to meet the rigorous demands of aseptic environments. Utilizing a hydrohermetic inlet and optimized bowl designs, it ensures gentle handling of sensitive materials like monoclonal antibodies and vaccines, maximizing yield without compromising purity.

This separator is invaluable for applications involving the clarification and concentration of complex biological products, ensuring contamination-free output of high-purity end-products such as insulin and DNA/RNA vaccines. With multiple customizable bowl configurations, it accommodates varied solid content levels, from 5 to over 35 vol%, seamlessly adapting to your process requirements.

The aseptic X model integrates smoothly into your production line with its PLC-controlled automation and GEA’s Direct Drive technology, reducing operational emissions in cleanroom settings. It supports continuous, high-speed operations with an automatic SIP (Sterilize-In-Place) capability that minimizes downtime and ensures compliance with ASME BPE standards for pharmaceutical manufacturing.

Engineered for efficiency, the separator is available in corrosion-resistant materials, promising longevity and compatibility with sensitive biopharma products. Its comprehensive cleanability and easy-maintenance design, featuring patented, gap-free welded disk spacers, makes it a reliable choice for maintaining high sanitation standards with reduced maintenance needs. For enhanced flexibility, GEA offers customization options to optimize the separator for specific process lines, backed by engineering support for installation and operation.

Benefits

  • Enhances product yield with seamless solid content management up to 35 vol%.
  • Ensures regulatory compliance with ASME BPE and aseptic processing standards.
  • Minimizes cross-contamination risk through hydrohermetic, gentle product handling.
  • Reduces operational emissions in cleanrooms with integrated Direct Drive technology.
  • Decreases cleaning time with automatic SIP and efficient CIP systems.

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General


Applications
Biopharmaceuticals,Pharmaceuticals
End products
Vaccines,Blood plasma products,Insulin,Cell culture-derived products,Monoclonal antibodies,Antibiotics,Dna/rna vaccines,Hormones,Recombinant proteins
Steps before
Filtration,Homogenization,Suspension Preparation,Mixing
Steps after
Sterilization,Validation,Packaging,Lyophilization
Input ingredients
biopharma products,shear sensitive products,cells,solid contents
Output ingredients
separated biopharma products,clarified liquids,concentrated solids
Market info
GEA is known for its expertise in engineering innovative and sustainable equipment and solutions, focusing on sectors such as food, beverages, pharmaceuticals, and energy, with a reputation for quality, efficiency, and advanced technological applications in industrial processing.

Technical Specifications


Aseptic skid bowl sizes
Four sizes available
Solid content capacity
Up to 35 vol%
Separation performance
High
Automation
Automatic SIP/CIP
Hydrohermetic inlet
Patented
Drive system
Integrated Direct Drive (IDD)
Yield optimization
Optimum yield with flexChange
Concentration range
Adjustable during production
System compatibility
ASME BPE
Cleanability features
Automatic SIP/CIP,highest cleanability requirements
Liquid acceleration
Smooth,no splashes
Bowl design
Three designs available

Operating Characteristics


Batch vs. continuous operation
Batch / Inline Continuous
CIP/SIP
Automatic SIP
Cleaning method
CIP / SIP
Automation level
PLC / SCADA
Smooth handling
No turbulences,no splashes,no shear forces
Flexibility
Static to flexible production
Shear sensitivity
Handles shear sensitive products gently

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm


ASME BPE
Included

Physical Characteristics


Bowl size
Four sizes available
Bowl design
Three designs
Feed method
Hydrohermetic inlet
Discharge method
Nozzle bowl
Skid design
Optimized for standard and customized requirements
Integrated Drive
Direct Drive (IDD)

Custom Options


Control panel type
PLC-controlled / HMI
Integration possibilities
Plug,produce / SCADA integration
Bowl design customization
Three bowl designs (High Sigma,HighVol,Flexicon)
Capacity adjustment
Four different bowl sizes
Concentration adjustment
Adjustable during production
Drive system
Integrated Direct Drive (IDD) with water-cooled motor