Life Science Filter
Protecting Life with Biosecurity Filtration
Hydrophilic Filter NOVAC HC
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NOVAC HC series features a membrane made of hydrophilically modified polytetrafluoroethylene (PTFE), offering excellent chemical compatibility and suitable for filtering pharmaceutical liquids containing organic solvents. NOVAC HC series pre-filters are available in disc, capsule, and cartridge formats, meeting the requirements of the entire process from R&D, pilot-scale to production
Product Features
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Hydrophilic membrane, no pre-wetting required
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Excellent chemical compatibility (pH 1-14)
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)
Typical Application
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Pre-filtration of pharmaceutical liquids containing organic solvents
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Pre-filtration of disinfectant and cleaning solutions
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Pre-filtration of antibiotic solutions
Based on the document "image_ba5126.png", here is the technical specification summary organized for easy selection:
NOVAC HC Series Filter Technical Specifications
1. Filter Types and Dimensions
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Capsule Filter:
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Nominal sizes: S, 2.5, 5, 10
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Filtration Area: 180cm2 (for S); 0.073 m2 (for 2.5); 0.23 m2 (for 5); 0.63 m2 (for 10)
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Cartridge Filter:
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Dimensions (phi63, phi70) with respective filtration areas (m2):
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2.5 inch: 0.12 / 0.17
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5 inch: 0.25 / 0.35
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10 inch: 0.50 / 0.70
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20 inch: 1.0 / 1.40
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30 inch: 1.5 / 2.10
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2. General Specifications
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Filter Aperture: 0.45 μm
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Materials of Construction:
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Support Layer, Shell, End Cap, Fin, Adaptor: PP
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Sealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKM
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Membrane material: Hydrophilic PTFE
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Hot-Melt Technology: Adhesive free technology
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3. Maximum Differential Pressure
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Capsule Filter:
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Forward: 5 bar (72.5 psi) @20°C / 3 bar (43.5 psi) @50°C (for L, M); 4 bar (58 psi) @20°C / 2 bar (29 psi) @50°C (for S)
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Backward: 2 bar (29 psi) @20°C / 1.5 bar (22 psi) @50°C
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Cartridge Filter:
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Forward: 5 bar (72.5 psi) @20°C / 2 bar (29 psi) @80°C
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Backward: 2 bar (29 psi) @20°C
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4. Sterilization and Regulatory Compliance
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Sterilization:
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Autoclave: 134°C * 30min * 25 times
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Online steam sterilization (Cartridge only): 134°C * 30min * 25 times (delta p <= 0.3 bar)
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Component Material Toxicity: Meets USP <88> Biological Reactivity for Class VI
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Ingredient Material Toxicity: Meets USP <88> Class VI plastics reaction test standards
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Cleanliness: Complies with FDA 21 CFR 211.72 and 210.3(b)(5)(6) for fiberless shedding filters, and USP <788> for insoluble particulate levels in the rinse solution
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Bacterial Endotoxin: Aqueous extraction contains < 0.25 EU/mL, meeting USP <85> requirements
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Integrity: Each cartridge/filter passes 100% integrity testing before it leaves the factory
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Production environment: All produced in 100,000 class clean room
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Product Parameters
Typical Applications
Related components
Related Equipment
Message consultation
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