PRODUCTS CENTER
Saudi Arabia Hydrophilic Filter NOVAC HC
Category:
Product Description
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)
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Standard |
Description |
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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
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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 |
|
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
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