PRODUCTS CENTER
Cameroon Syringe Filter for Liquid Filtration HALOD
Category:
Product Description
Filtering is an ideal method for clarifying liquids and sterilization. Through the filtration by filter membranes, it can effectively remove microorganisms and particles without affecting the active ingredients due to adsorption or decomposition.
Advanced Bio-Pharma Filtration Solutions
Enhance yield and ensure compliance with Feature-Tec’s precision-engineered filtration technologies.
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Targeted Applications: mAb Production, Vaccine Processing, ADC Manufacturing, & Fermentation.
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Core Technologies: Depth Filtration, Bioburden Reduction, & Automatic Integrity Testing.
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Expert Services: Full Process Validation & Technical Support.
International Standards & Regulatory Compliance
Feature-Tec Sterilizing-Grade Filter Certifications & Compliance
1、Core Function & Definition (Sterilizing-Grade Identity)
|
Standard |
Description |
|
ASTM F838 |
Validated to the internationally recognized "gold standard" for bacterial retention in sterilizing-grade filters |
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PDA TR No. 26 |
Establishes scientific correlation between integrity testing and bacterial retention performance |
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21 CFR 211.65 |
Compliant with FDA requirements for material safety of pharmaceutical manufacturing equipment |
2、Biosafety & Patient Safety
|
Standard |
Description |
|
USP <88> / ISO 10993 |
Validated for biocompatibility per USP Class VI and ISO 10993 requirements |
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USP <85> / EP 2.6.14 |
Complies with bacterial endotoxin limits to support injectable product safety |
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ICH Q3D / USP <232> |
Complies with elemental impurity control requirements |
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USP <788> |
Complies with sub-visible particulate matter requirements for injectable quality |
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BPOG Protocol (2014) |
Characterized per BPOG extractables protocol to support chemical compatibility assessment |
3、Manufacturing Process & Batch Consistency
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Standard |
Description |
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ISO 11137 (VDmax) |
Validated for gamma irradiation sterilization, achieving SAL 10⁻⁶ sterility assurance level |
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ICH Q1A (R2), Q1E |
Validated through accelerated and long-term stability studies to support claimed shelf life |
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ISO 9001 / 13485 |
Certified to quality management systems, ensuring consistent product quality and full traceability |
4、Process Operations & Performance
|
Standard |
Description |
|
USP <643> / <645> |
Post-flush residuals comply with USP Water for Injection (WFI) quality requirements |
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ISTA 2A / ASTM F2096 |
Validated for packaging integrity to maintain sterile barrier during transportation |
5、Regulatory & Supply Chain Compliance Statements
|
Standard |
Description |
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21 CFR 177-182 |
Materials comply with FDA requirements for indirect food-contact materials |
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GMO (EC) / BSE/TSE / BPA |
Supporting declarations available: Non-GMO, BSE/TSE-Free, BPA-Free (where applicable) |
Product Features
- With reliable bacterial retention capacity
- Extensive chemical compatibility (pH 1-14)
- Unique membrane structure, which can increase loading capacity
- Robust Structure
Typical Applications
- Sterilization filtration of cell culture medium
- Buffer filtration
- Pre-protection before column/ultrafiltration
- Reliable bacterial retention capacity
- Widely compatible with chemicals (pH 1-14)
- Robust structure, resistant to multiple sterilization
Parameters(HALOD Syringe Filter Compact Selection Table)
| Parameter | HALOD Syringe Filter |
|---|---|
| Filtration Area (cm²) | Single-layer: 3.5cm²Dual-layers: 3.5cm² |
| Pore Size | 0.2-70μm |
| Structure | Support Layer: PP; Shell: PP; Membrane material: See the order information |
| Max Forward Differential Pressure | 5 bar (72.5 psi) @20°C |
| Max Backward Differential Pressure | 2 bar (29psi) @20°C |
| Sterilization | Resistant to autoclaving and irradiation |
| Bacterial Challenge | >10⁷ cfu/cm² B.diminuta (ATCC 19146) |
| Biosafety | Components materials meet the criteria of the USP<88> Biological Reactivity for Class VI |
| Clealiness | Comply with FDA 21 CFR 211.72 and 210.3(b)(5)(6) for no fiber release filters, and USP <788> for insoluble particulate levels in the flush water |
| Material Toxicity | Component materials meet USP <88> Class VI plastics biological reactivity standards |
| Endotoxin | <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
| Integrity | 100% integrity testing before filter release |
| Manufacture Environment | Manufactured in the 100,000 class clean room |
Contact
Hotline: (+86)400-820-6150
Email: marketing@feature-tec.com
Address: 8/F, Block A, Building 3, Tianhua Information Technology Park, 299 Longcao Road, Xuhui District, Shanghai