Cell Harvest Single-Use Filtration Assembly
The system is designed to reduce handling steps between bioreactor harvest and clarification, while maintaining stable performance under variable cell densities.
- Product Introduction
Product Overview
This is a closed, pre-assembled filtration assembly integrating filtration modules, tubing, and connectors into a single disposable system.
All fluid-contact components are assembled and leak-tested before delivery. No onsite tubing assembly is required.
The system is designed to reduce handling steps between bioreactor harvest and clarification, while maintaining stable performance under variable cell densities.
Technical Specifications
|
Parameter |
Description |
|
Filtration types |
Depth / membrane / hybrid configuration |
|
Pore sizes |
0.1 µm / 0.2 µm / 0.45 µm / 1.0 µm (configurable) |
|
Flow capacity |
Lab to production scale (application dependent) |
|
Operating pressure |
Standard bioprocess harvest conditions |
|
Sterilization |
Gamma-compatible / pre-sterilized options |
|
Tubing material |
Biopharmaceutical-grade silicone / TPE |
|
Connector types |
TC / sanitary flange / hose barb / custom |
|
System format |
Fully closed single-use assembly |
Engineering Features
Closed pre-assembled fluid path
The full fluid path is completed before shipment. No open assembly is required during installation, which reduces contamination exposure during setup and transfer.
Reduced manual operations
By eliminating onsite tubing connection and assembly steps, the system reduces operator-dependent variation between batches.
Configurable filtration design
The assembly can be configured according to process requirements:
- Depth filtration for high solids or dense cultures
- Membrane filtration for fine clarification
- Multi-stage configurations for higher throughput stability
Fewer connection interfaces
Integrated tubing design reduces external connection points, lowering leakage risk and simplifying installation in cleanroom environments.
Scalable system architecture
The same design concept can be applied from laboratory development to full production scale without changing the process workflow.
Application Areas
Monoclonal antibody (mAb) production
Vaccine manufacturing
Recombinant protein production
Cell and gene therapy processes
Microbial fermentation clarification
Biopharmaceutical pilot and GMP production
Typical Configurations
Single-Stage Depth Filtration: For standard cell culture harvest applications.
Dual-Stage Systems (Depth + Membrane): For enhanced downstream filtrate clarity.
High-Density Configuration: Tailored for high-solids loading and high cell-density harvest.
Inline Sterile Filtration: Integrated 0.2 µm final membrane to secure bioburden control.
Multi-Line / Manifold Setup: Configured for parallel or automated split-stream processing.
Comparison with Alternative Systems
|
Feature / Metric |
Jiuling Single-Use Assembly |
Reusable Stainless Steel Systems |
Standalone Filter Capsules / Manual Assemblies |
|
Cleaning & Sterilization |
Zero (Disposable fluid path) |
Intensive CIP/SIP cycles required |
Variable; requires manual integration |
|
Validation Overhead |
Minimal (Pre-validated) |
High validation & maintenance costs |
High risk of manual assembly error |
|
Risk of Leakage/Contamination |
Extremely Low (Closed & pre-tested) |
Medium (Valves/Gaskets wear) |
High (Multiple manual connection points) |
|
Turnaround Time |
Immediate replacement |
Long downtime for autoclaving/cleaning |
Moderate setup time per batch |
Quality Assurance & Regulatory Documentation
Every Jiuling single-use assembly is manufactured under a stringent quality management system within controlled cleanroom environments (ISO Class 7 / Class 8). Our standard documentation package supports your regulatory and GMP filing requirements, including:
Certificate of Conformity (CoC) verifying material compliance (USP Class VI, FDA).
Material Traceability Records (Lot-to-lot traceability for all fluid-contact components).
Assembly Integrity Verification Report (Pressure decay / leak test data).
Sterilization Validation Documents (Gamma irradiation certificate conforming to ISO 11137, if applicable).
Extractables & Leachables (E&L) data support based on BPOG / USP <1228> guidelines (available upon request).
FAQ
Q: Can the system connect directly to standard bioreactors?
A: Yes. Connector options can be configured to match most standard bioreactor harvest ports.
Q: What is the main advantage over stainless steel systems?
A: It eliminates cleaning and sterilization cycles and reduces batch changeover time.
Q: Can the filtration configuration be adjusted for different cell densities?
A: Yes. Depth and membrane combinations can be selected based on harvest conditions.
Q: Is validation documentation available?
A: Yes. Traceability, assembly verification, and sterilization-related documents can be provided when required.
Q: Is this suitable for GMP manufacturing?
A: Yes. It is designed for use in GMP environments where single-use systems are commonly adopted.
Q: Can tubing length and connectors be customized?
A: Yes. Both tubing layout and connector types can be tailored to process requirements.
Q: How is scale-up handled?
A: The system uses the same design concept across scales, allowing direct process transfer from lab to production.
Q: Can it be used for high-cell-density cultures?
A: Yes. Multi-stage configurations are recommended for high-density or high-solids harvest streams.
Custom Engineering Support
Each process has different harvest conditions. Jiuling provides application-based system configuration support based on:
- Cell density and viability
- Required clarification performance
- Flow rate and batch volume
- Integration with existing process equipment
Contact us to discuss your application and receive a tailored solution.
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