Device built-in

Product Introduction: Sartorius Pilot-Scale Depth Filtration Holder

As a global leader in biopharmaceutical process equipment, Sartorius' pilot-scale depth filtration holder is specifically designed for critical processes such as bioproduct clarification and harvest fluid pretreatment. Engineered for pilot-scale production (50-500L), it combines the flexibility of laboratory R&D with production-grade reliability.

Core Features

1. Modular Design

• 316L stainless steel construction compliant with FDA 21 CFR and USP Class VI standards
• Flexible configurations from single-layer (1-3 cartridges) to multi-layer (up to 10 cartridges)
• Quick-install sanitary clamp connections (Tri-Clamp/DIN standard) supporting CIP

2. Process Adaptability

• Compatible with Sartopure® PP series multi-layer depth filter cartridges (0.1-5μm precision)
• Integrated 0-6Bar pressure monitoring ports with standard 80℃ temperature tolerance
• Optional load cells for process volume control

3. Regulatory Compliance

• Complete IQ/OQ validation documentation package (including 3D drawings and material certificates)
• All product contact surfaces electropolished (Ra≤0.8μm)
• Supports both single-use and reusable modes

Typical Applications

• mAb production: Primary clarification of cell culture fluid
• Vaccine manufacturing: Pretreatment of virus harvest fluid
• Gene therapy: Crude purification of plasmid DNA
• Culture media/buffers: Pre-sterile filtration

Service Support

• Validation services: Full-cycle support from DQ to PQ
• Consumables: Complete solution with original cartridges and holder
• Technical training: Included in equipment FAT/SAT

Technical Parameters

• Operating pressure: ≤5Bar (design pressure 6Bar)
• Flow rate range: 10-300L/min (depending on cartridge type)
• Hold-up volume: ＜1.5L (standard configuration)

This product has been successfully implemented in multiple ADC drug pilot platforms in China, demonstrating over 15% improvement in target product recovery compared to traditional centrifugation clarification processes. Sartorius provides complete filtration solutions ranging from laboratory scale (5L) to production scale (2000L+).