Clarification Single-Use Filtration Assembly

 

Jiuling provides single-use clarification filtration assemblies designed for solid-liquid separation in bioprocessing. The system is used in harvest clarification to remove cells, debris, and suspended solids before downstream purification steps.
It is supplied as a pre-assembled disposable fluid path, suitable for GMP production and process development where cleaning validation needs to be minimized.

 

 

Parameter	Description
Filtration Range	0.1 / 0.2 / 0.45 / 1.0 µm (depending on design)
System Types	Capsule / Inline / Integrated tubing assemblies
Flow Capacity	Lab scale to production scale
Operating Pressure	Compatible with standard bioprocess conditions
Differential Pressure	Used as key operating control parameter
Hold-up Volume	Optimized by flow path design (customizable)
Temperature Range	Compatible with standard bioprocess fluids
Sterilization	Gamma irradiation compatible / non-sterile options
Connector Types	TC / sanitary flange / hose barb / custom fittings
Materials	Bioprocess-grade polymers for fluid contact

 

 

Reduced Validation Workload
100% single-use design entirely removes the requirement for cleaning validation (CIP/SIP) and drastically cuts down changeover documentation.

Lowered Cross-Batch Risk
Zero reuse of fluid-contact components minimizes the risk of product-to-product contamination in multi-product or CMO/CDMO facilities.

Stable Batch Consistency
Every assembly is manufactured under strict quality controls with consistent fluid path geometries to ensure reproducible batch-to-batch filtration performance.

Accelerated Changeover Time
Pre-assembled, ready-to-use configurations minimize setup and installation times prior to a batch run.

Flexible Skid Integration
Readily adaptable to small-scale process development equipment as well as large-scale automated commercial production skids.

 

 

This single-use system serves as a primary clarification step bridging cell culture/fermentation harvest and downstream purification (such as depth filtration, membrane filtration, or chromatography).
Its primary purpose is to significantly reduce particulate and bioburden load at an early stage, thereby protecting expensive downstream filters and purification columns.

 

 

This single-use assembly is recommended when the manufacturing process exhibits the following characteristics:
High Upstream Variability: Harvest contains high cell density, high turbidity, or fluctuating/unstable solid loads.
Agile Manufacturing Requirements: Fast batch turnaround times are required, or the facility operates under a multi-product manufacturing model.
Operational Bottlenecks: Cleaning and sterilization validation (CIP/SIP) of reusable stainless-steel housing systems creates regulatory or operational bottlenecks.

 

 

To ensure seamless integration with various bioreactor and skid designs, assemblies can be customized into multiple formats:
Multi-Stage Clarification Trains: Integrated depth filter + membrane filter combinations.
Capsule-Based Systems: Fully disposable, self-contained capsule configurations for clean handling.
Inline Manifold Assemblies: Integrated tubing networks complete with connectors, sanitary fittings, and pre-installed sensors.
Custom Process Integration: Tailored connections matching specific flow rates, hold-up volume reduction goals, and bioreactor harvest lines.

 

 

Item	Single-Use Assembly	Reusable Stainless System
Cleaning validation	Not required	Required
Batch changeover time	Short	Long
Cross-contamination risk	Lower	Higher
Operational complexity	Low	High
Multi-product use	Flexible	Limited

 

 

Every fluid path assembly is manufactured under rigorous regulatory controls to support international compliance:
Full Material Traceability: 100% component traceability with documentation support for validation requirements (CoA/CoC).
Regulated Cleanroom Assembly: Produced in controlled clean environments with multi-step quality inspections.
Integrity Assured: Pressure integrity and component checks are performed where applicable.
Clean Handling & Packaging: Strict bioburden controls during final assembly and secure protective packaging phases.

 

 

Jiuling provides highly flexible customization capabilities to match your exact process needs:
Tubing Tailoring: Custom tubing lengths, inner/outer diameters, and material choices (Silicone, TPE, etc.).
Connector Standards: Comprehensive range of fittings including TC flanges, quick disconnects, and aseptic connectors.
Process Packaging: Provision of sterile gamma-irradiated packaging or non-sterile bulk configurations.
Manifold Design: Engineering support for multi-stage configurations, integrating single-use sensors or validation sampling ports.

 

 

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