PRODUCTS CENTER
Papua New Guinea Vacuum Filtration Device FeaVacu
Category:
Product Description
To enhance the filtration efficiency of complex aqueous solutions such as cell culture media, different types of filter membranes can be combined with the FeaVacu vacuum filtration device top to achieve rapid flow rate and high throughput, while avoiding cell culture contamination. The FeaVacu vacuum filtration device is an ideal laboratory consumable, made from polystyrene (PS) that meets USP Class VI standards. Currently, the product specificaitons available are 250mL, 500mL, and 1000mL. The entire filtration system consists of a vacuum bottle top with a nozzle and a receiving bottle.
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
|
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 |
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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
|
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 |
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GMO (EC) / BSE/TSE / BPA |
Supporting declarations available: Non-GMO, BSE/TSE-Free, BPA-Free (where applicable) |
Product Features
- 3 different sizes: 250mL, 500mL and 1000mL
- Single-use, dispose immediately
- Flexible choice: 0.22μm membranes of different materials are
- available for selection
Typical Applications
- Sterilization filtration of cell culture medium and serum
- Buffer filtration
- Filtration for sterilization of other solutions not suitable for autoclaving
Parameters(Vacuum Filtration Device Compact Selection Table)
| Parameter | Vacuum Filtration Device |
|---|---|
| Specification | 250ml, 500ml, 1000ml |
| Pore Size | 0.22 μm |
| Construction | Raw material: Polystyrene (PS)Membrane: PES, PVDF, PTFE or others |
| Sterilization | Resistant to electron beam irradiation |
| Bacterial Challenge | >10⁷ cfu/cm² B.diminuta (ATCC 19146) |
| Biosafety | Components materials meet the criteria of the USP<88> Biological Reactivity for Class VI |
| Clealiness | Comply with FDA 21 CFR 211.72 and 210.3(b)(5)(6) for no fiber release filters, and USP <788> for insoluble particulate levels in the flush water |
| Material Toxicity | Component materials meet USP <88> Class VI plastics biological reactivity standards |
| Endotoxin | <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
| Manufacture Environment | Manufactured in the 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