Life Science Filter
Protecting Life with Biosecurity Filtration
Sterilizing Filters AIVITAC SP
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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
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 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, etcDimensions
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 -
Product Parameters
Typical Applications
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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