Life Science Filter
Protecting Life with Biosecurity Filtration
Disc Filter for Gas Filtration HALOS
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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
PDA TR No. 26
Establishes scientific correlation between integrity testing and bacterial retention performance
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
USP <85> / EP 2.6.14
Complies with bacterial endotoxin limits to support injectable product safety
ICH Q3D / USP <232>
Complies with elemental impurity control requirements
USP <788>
Complies with sub-visible particulate matter requirements for injectable quality
BPOG Protocol (2014)
Characterized per BPOG extractables protocol to support chemical compatibility assessment
3、Manufacturing Process & Batch Consistency
Standard
Description
ISO 11137 (VDmax)
Validated for gamma irradiation sterilization, achieving SAL 10⁻⁶ sterility assurance level
ICH Q1A (R2), Q1E
Validated through accelerated and long-term stability studies to support claimed shelf life
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
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
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 -
Product Parameters
Typical Applications
Related components
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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