PRODUCTS CENTER
togo Sterilizing Filters AIVITAC SP
Category:
Product Description
AIVITAC SP series filters are made of naturally hydrophobic polytetrafluoroethylene membrane (PTFE). They have excellent compatibility for gas sterilizing filtration.
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
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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) |
Product Feature
• Excellent hydrophobicity
• Resistant to high temperature , high pressure
• Withstand multiple sterilization cycles
• Reliable retention of bacteria and particles
• High flux and low pressure drop
Applications
• Air respirators for storage tanks / fermenters
• Sterilization and filtration of compressed air, O2, N2, etc
Dimensions
| Parameter | Capsule Filters | Cartridge Filters |
| Nominal size (inches) | S, 2.5, 5, 10 | 2.5, 5, 10, 20, 30 |
| Filtration Area (m²) |
S: 180 cm² 2.5: 0.073 / 5: 0.23 / 10: 0.63 |
Φ63: 0.12, 0.25, 0.50, 1.0, 1.50 Φ70: 0.17, 0.35, 0.70, 1.40, 2.10 |
| Pore Size | 0.22 μm | 0.22 μm |
| Materials of Construction |
Support Layer: PP; End Cap: PP; Adaptor: PP Sealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKM Hot-Melt Technology: Adhesive free technology Membrane material: PTFE |
Support Layer: PP; End Cap: PP; Adaptor: PP Sealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKM Hot-Melt Technology: Adhesive free technology Membrane material: PTFE |
| Max. Forward Differential Pressure |
L, M: 5 bar (72.5 psi) @ 20°C / 3 bar (43.5 psi) @ 50°C S: 4 bar (58 psi) @ 20°C / 2 bar (29 psi) @ 50°C |
5 bar (72.5 psi) @ 20°C 2 bar (29 psi) @ 80°C |
| Max. Backward Differential Pressure |
2 bar (29 psi) @ 20°C 1.5 bar (22 psi) @ 50°C |
2 bar (29 psi) @ 20°C |
| Sterilization | Autoclave: 134°C * 30 min * 25 times |
Autoclave: 134°C * 30 min * 100 times Online steam sterilization: 134°C * 30 min * 100 times (Δp ≤ 0.3 bar) |
| Bacterial Interception | > 10⁷ cfu / cm² B.diminuta (ATCC 19146) | > 10⁷ cfu / cm² B.diminuta (ATCC 19146) |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Biological Reactivity for Class VI | Component materials meet the criteria of the USP <88> Biological Reactivity for Class VI |
| Cleanliness | Comply 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. | Comply 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. |
| Ingredient Material Toxicity | Component materials meet USP <88> Class VI plastics reaction test standards. | Component materials meet USP <88> Class VI plastics reaction test standards. |
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL which meet USP <85> requirements | Aqueous extraction contains < 0.25 EU/mL which meet USP <85> requirements |
| Integrity | Each filter passes 100% integrity testing before it leaves the factory. | Each cartridge passes 100% integrity testing before it leaves the factory. |
| Production Environment | All produced in 100,000 class clean room | 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