PRODUCTS CENTER
Saudi Arabia Disc Filter for Gas Filtration HALOS
Category:
Product Description
Hydrophobic membrane filters are suitable for venting, sterilizing gas filtration in small containersand online gas pipelines.
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 |
|
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
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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 |
|
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
- Hydrophobic
- Resistance to high temperature, high pressure and sterilization
- High flux and low pressure drop
- Bacterial retention capability
Typical Applications
- Vent for storage tanks / fermentation tanks
- Sterilizing Filtration for compressed air, O2, N2, etc.
Parameters（HALOS Disc Filter Compact Selection Table）
| Parameter | HALOS Disc Filter |
|---|---|
| Filtration Area (cm²) | 20 cm² |
| Pore Size | 0.22μm, 10μm |
| Construction | Support Layer: PP; Shell: PP; Membrane material: See the order information |
| Max Forward Differential Pressure | 3 bar (43.5 psi) @20°C |
| Max Backward Differential Pressure | 2 bar (29 psi) @20°C |
| Sterilization | Resistant to autoclaving (HALOS® PES 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 |
| Cleanness | 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