PRODUCTS CENTER
Papua New Guinea Sterilizing-grade gas filter AIREPAC SP
Category:
Product Description
AIREPAC SP series sterilizing-grade gas filters are made of hydrophobic polyethersulfone (PES) membrane. They are specifically designed for single-use systems, delivering excellent performance in gas filtration and venting applications, especially in processes requiring irradiation sterilization. AIREPAC SP series is available in both disc and capsule formats, offering a full range of sizes and dimensions from small to large, flexibly meeting the needs of various application scenarios.
Product Features
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Excellent hydrophobicity
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Resistant to autoclaving and gamma irradiation
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Reliable bacterial and particulate retention
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High flux and low pressure drop
Typical Application
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Single-use system application
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Sterilization and filtration of compressed air, O2, N2, etc.
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Air Breather Filter for Fermenters, Storage Tanks, and Dosing Tanks
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
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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) |
AIREPAC SP Series Filter Selection Guide
1. Filter Specifications and Filtration Area
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Disc Filters: Available in 20 cm² and 180 cm² filtration areas.
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Capsule Filters: Available in 2.5, 5, and 10 inch nominal sizes, corresponding to 0.073 m², 0.23 m², and 0.63 m² filtration areas respectively.
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Pore Size: Standardized at 0.22 μm for all models.
2. Pressure Tolerance (Maximum differential pressure)
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Forward Pressure: ≤ 2 bar at 20°C.
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Backward Pressure: ≤ 1.2 bar at 20°C.
3. Sterilization and Irradiation Tolerance
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Irradiation: Resistant to ≤ 50 kGy.
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Electron beam irradiation: Cannot be sterilized.
4. Performance and Regulatory Compliance
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Bacterial Interception: > 10^7 cfu / cm² (B.diminuta, ATCC 19146).
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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 rinse solutions.
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Bacterial Endotoxin: Aqueous extraction contains < 0.25 EU/mL, meeting USP <85> requirements.
5. Quality Assurance and Environment
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Integrity: Each cartridge/filter passes 100% integrity testing before leaving the factory.
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Production Environment: All products are manufactured in a 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