PRODUCTS CENTER
Russia Sterilizing Filters PURIAGIS SP
Category:
Product Description
The PURIAGIS SP series filters are made of naturally hydrophobic polytetrafluoroethylene membrane (PTFE). They offer broad chemical compatibility for organic solvents sterilizing filtration.
Advanced Bio-Pharma Filtration Solutions
Enhance yield and ensure compliance with Feature-Tec’s precision-engineered filtration technologies.
-
Targeted Applications: mAb Production, Vaccine Processing, ADC Manufacturing, & Fermentation.
-
Core Technologies: Depth Filtration, Bioburden Reduction, & Automatic Integrity Testing.
-
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 temperatures, high pressure
• Withstand multiple sterilization cycles
• Reliable retention of bacteria and particles
Applications
• Decontamination and filtration of organic solvents
• Carification and decarburization filtration of organic solvents
Dimensions
| Category | Sub-category | Capsule Filters (S / 2.5" / 5" / 10") | Cartridge Filters (2.5" / 5" / 10" / 20" / 30") |
|---|---|---|---|
| Nominal size (inches) | - | S, 2.5, 5, 10 | 2.5, 5, 10, 20, 30 |
| Filtration Area (m²) | φ63 | S: 180cm²; 2.5": 0.073; 5": 0.23; 10": 0.63 | 2.5": 0.12; 5": 0.25; 10": 0.50; 20": 1.0; 30": 1.50 |
| φ70 | - | 2.5": 0.17; 5": 0.35; 10": 0.70; 20": 1.40; 30": 2.10 | |
| Pore Size | - | 0.22μm | 0.22μm |
| Materials of Construction | - | Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PTFE | Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PTFE |
| Maximum differential pressure | Forward (L, M) | 5bar (72.5psi) @20°C3bar (43.5psi) @50°C | 5bar (72.5psi) @20°C2bar (29psi) @80°C |
| Forward (S) | 4bar (58psi) @20°C | - | |
| Backward | 2bar (29psi) @20°C1.5bar (22psi) @50°C | 2bar (29psi) @20°C | |
| Sterilization | - | Autoclave: 134°C30min25 times | Autoclave: 134°C30min25 timesOnline steam sterilization: 134°C30min25 times (Δp≤0.3bar) |
| Bacterial interception | - | >10⁷cfu / cm² B.diminuta (ATCC 19146) | >10⁷cfu / cm² B.diminuta (ATCC 19146) |
| Component Material Toxicity | - | Components materials meet the criteria of the USP<88> Biological Reactivity for Class VI | Components materials meet the criteria of the USP<88> Biological Reactivity for Class VI |
| Cleanness | - | 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 cartridge/filter passes 100% integrity testing before it leaves the factory. | Each cartridge/filter 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