Sterile Single-Use Filtration Assembly
Sterile Single-Use Filtration Assembly is a pre-assembled, gamma-irradiated system designed for aseptic liquid processing without cleaning or sterilization before use.
- Product Introduction
Product Overview
Sterile Single-Use Filtration Assembly is a pre-assembled, gamma-irradiated system designed for aseptic liquid processing without cleaning or sterilization before use.
It is used in processes where contamination control, fast changeover, and reduced cleaning validation are required.
Each assembly is delivered as a closed, ready-to-use fluid path for direct installation into bioprocessing systems.
Technical Specifications
|
Parameter |
Description |
|
Filtration Ratings |
0.1 / 0.2 / 0.45 / 1.0 µm |
|
Assembly Type |
Capsule / Inline / Tubing-integrated |
|
Sterilization |
Gamma irradiation |
|
Sterility |
Double sterile barrier packaging |
|
Operating Conditions |
Standard bioprocess pressure range |
|
Flow Capacity |
Lab to production scale (configuration dependent) |
|
Tubing Material |
Medical-grade single-use tubing |
|
Connectors |
TC / sanitary / hose barb / Luer / custom |
|
Traceability |
Batch-level identification system |
|
Customization |
Layout, tubing, connectors, filter selection |
Key Features
Closed Pre-Assembled System
The entire fluid path is delivered pre-connected and ready for immediate deployment. By removing on-site assembly requirements, it significantly reduces operator variability, setup errors, and manual handling contamination risks.
Highly Configurable Design
Filtration Ratings: Available in 0.1 µm, 0.2 µm, 0.45 µm, and 1.0 µm parameters.
Process Adaptability: Tubing length, diameter, layout, and connector types can be customized to match specific flow rates, fluid types, and system integration needs.
Bioprocess-Compatible Materials
All fluid-contact materials comply with USP Class VI and ISO 10993 biocompatibility standards. Selected materials exhibit chemical compatibility with buffer solutions, culture media, protein-based products, and process intermediates, offering controlled and documented extractables/leachables profiles.
Optimized Changeover Efficiency
By bypassing traditional cleaning and sterilization cycles, the assembly can be installed directly into production lines. This is an ideal solution for multi-product facilities, campaign manufacturing, and modern single-use facilities aiming to maximize facility uptime.
Applications
Biopharmaceutical Processing: Buffer/media sterile filtration, intermediate solution clarification, and pre-filtration before sterile filling.
Vaccine Manufacturing: Sterile filtration of formulation solutions, aseptic fluid transfer between downstream steps, and small-batch production.
Cell & Gene Therapy: Closed-system fluid transfer, small-volume sterile handling, and processing of high-value, sensitive products.
Food & Beverage Processing: Sterile filtration of sensitive liquid ingredients, additives, and flavor solution preparations.
Process Development & Pilot Scale: Process optimization studies, scale-up evaluation, and clinical trial batch manufacturing.
System Configuration
Each assembly is engineered as a complete single-use flow path, tailored to mitigate installation variability and connection errors:
Filtration Component: Sterile filter capsule or inline filter module.
Tubing System: Pre-connected, medical-grade single-use tubing set.
Sterile Connectors: Sanitized TC (Sanitary Flange), hose barb, Luer, or customized aseptic connectors.
Integrated Accessories: Optional sampling ports, vent filters, or aseptic transfer lines based on process architecture.
Packaging & Delivery
Individually sealed using a secure double sterile barrier system to maintain product integrity.
Packed in export-grade protective cartons to prevent damage during long-distance transit.
Clear labeling featuring unique batch numbers, expiry dates, and product specifications for effortless inventory tracking.
Validated and approved for international air and sea shipments.
FAQ
Q: Is the system supplied sterile and ready to use?
A: Yes. Each assembly is gamma-irradiated and delivered in sterile sealed packaging.
Q: Can the assembly be customized?
A: Yes. Tubing length, connectors, filter rating, and system layout can be customized based on process requirements.
Q: What is the advantage of single-use assemblies?
A: They remove cleaning and sterilization steps, reduce contamination risk, and shorten batch changeover time.
Q: Do you provide validation or QA documents?
A: Yes. Sterilization summary, material certificates, and batch traceability records can be provided for QA review.
Q: Is this suitable for GMP manufacturing environments?
A: Yes. The system is designed for use in GMP-controlled production environments with full batch traceability.
Q: What is the lead time for customized systems?
A: Lead time depends on configuration and order volume. Standard and custom designs are available for scalable supply.
Q: Can connectors be pre-integrated before sterilization?
A: Yes. Connector assembly is completed before sterilization to ensure a closed sterile system upon delivery.
Q: How is sterility maintained during transport?
A: A double sterile barrier packaging system is used to protect sterility during storage and global shipment.
Inquiry & Technical Support
Jiuling provides standard and customized single-use filtration assemblies for global bioprocess applications.
We support customers with:
- Process-specific configuration design
- Technical drawing and system layout review
- Validation and documentation support
- Scalable production supply
Contact us to request technical details or a quotation based on your process requirements.
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