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Prefiltration and Bioburden Reduction

Efficient Particle Removal and Protection: Prefilters for Optimized Filtration Processes

In biopharmaceutical manufacturing, prefiltration and bioburden reduction are critical for ensuring product quality and process reliability. Intensified processes and highly concentrated feedstreams require efficient prefiltration to increase overall throughput and minimize contamination risks during filtration.

Sartorius offers a comprehensive portfolio of prefilters designed to remove particles and reduce microbial load, protecting downstream filters and improving efficiency. Tailored for a wide range of applications, our solutions deliver clarity, safety, and cost-effectiveness.

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Prefiltration & Bioburden Reduction Solutions

Sartoguard, Sartoclean® & Sartopure®

In the pharmaceutical and biopharmaceutical industries, achieving product purity and safety is paramount. Efficient prefiltration solutions are essential for enhancing sterilizing-grade filter performance by minimizing particle burden and microbial contamination. Sartorius offers solutions with high dirt-holding capacity, scalability, and flexibility—including a range of filtration media (such as membrane filters and fleece-based filters)—optimized for complex bioprocess fluids and supporting diverse applications and process volumes.

 

Particle reduction filters serve as the first line of defense, removing coarse particles and protecting downstream equipment. These filters are ideal for early-stage clarification of complex or viscous feedstreams in biopharmaceutical and pharmaceutical processes

 

FeatureSartopure® PP3Sartopure® GF Plus
Filter MediaPolypropylene fleeceHighly charged glass fiber fleece
Retention Range0.45-0.5 µm0.65-1.2 µm
Key Applications

Prefiltration and clarification of:

  • Vaccines
  • pDNA
  • Ophthalmic solutions
  • Large volume parenterals (LVPs)
  • Antibiotics
  • Solvents
  • Viral vectors (Lentivirus)

Protection of downstream equipment

Prefiltration and clarification of:

  • Cell culture fluids after cell harvest
  • Fermentation broths
  • Serum-free or serum-containing cell culture media
  • Serum
  • Highly viscous ophthalmic and LVP solutions
  • Media, containing lipids and colloids as contaminants
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Bioburden reduction filters are used downstream as prefilters to reduce microbial load and protect sterile filtration. These filters help ensure microbial purity in media, buffers, and final formulations.

 

FeatureSartoguard GFSartoguard PESSartoclean® GF
Filter MediaGlass fiber prefilter and PES membraneDual-layer PES membranesGlass fiber prefilter and cellulose acetate membrane
Retention Range0.2 µm0.1-0.2 µm3.0 μm and 0.8 μm, 0.8 μm and 0.65 μm
Key Applications
  • Prefiltration of cell culture media, buffers, and serum
  • Bioburden reduction for protein, pDNA, and mRNA solutions
  • Protection of sterilizing-grade filters
  • Bioburden reduction in protein-based formulations
  • Sensitive biologics
  • Final prefiltration before sterile filtration
  • Prefiltration of serum, plasma, and cell culture media
  • Vaccines
  • Monoclonal antibodies (mAbs)
  • Diagnostics
  • Biological fluids with preservatives
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Unmatched Filtration Expertise: Sartorius Prefiltration Solutions

At Sartorius, we engineer high-performance prefilters designed to protect your downstream systems and ensure microbial integrity. Whether for buffer clarification, cell harvests, or sterile drug manufacturing, our solutions—featuring advanced fleece and membrane technologies—deliver consistent performance. Sartopure® PP3, Sartopure® GF Plus, Sartoguard®, and Sartoclean® filters offer trusted protection across a wide range of bioprocess applications, minimizing filter fouling and extending final filter life. Designed for scalability, reproducibility, and compliance, our prefiltration portfolio supports particle reduction, harvest clarification, and robust bioburden control.

Frequently Asked Questions

Prefiltration removes large particles before final filtration, reducing filter fouling and increasing the lifespan of sterilizing-grade membranes. This step improves overall efficiency, reduces costs, and ensures consistent process performance.

Bioburden reduction lowers microbial levels in fluids before sterilizing filtration. It is essential in biopharmaceutical manufacturing to prevent microbial contamination, ensure product safety, and meet regulatory requirements for sterility.

Fleece filters capture particles within the depth of their layered structure, while membrane filters act as surface barriers. Fleece filters are ideal for coarse and colloidal particles; membranes are suited for final or sterile filtration requiring absolute retention.

Sartorius offers Sartopure® PP3, Sartopure® GF Plus, Sartoclean® GF, and Sartoguard PES. These prefilters support efficient particle removal and bioburden reduction across various applications, ensuring reliable and scalable performance.

Selection depends on fluid type, particle load, and process requirements. Fleece-based filters work well for high particulate loads, while pleated depth or membrane prefilters offer higher retention precision for critical bioburden reduction applications.

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