Life Science Filter
Protecting Life with Biosecurity Filtration
Integrity Test Dolintestor FT 4.0
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Dolintestor FT 4.0 Integrity Tester is a high-quality testing instrument independently developed by Featuretec according to the current GAMP guidelines. It ensures accurate testing of filter integrity with short testing time and high accuracy, suitable for any cleanroom enviro nment.Dolintestor FT 4.0 Integrity Tester provides testing functions including manual bubble point, basic bubble point, enhanced bubble point, diffusion flow, water intrusion, and pressure decay. It not only meets the integrity testing requirements of sterilizing filters but also meets the integrity testing requirements of ultrafiltration membrane cartridges, hollow fiber membranes and virus removal filter. The testing scenarios can be both offline and online.
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)
High performance
- Excellent internal sealing performance to ensure the test data accuracy.
- Optimized algorithm and automatic adjustment of intake air flow to shorten the test time.
- Intelligent analysis capability by excluding human error in the test results, and fake cartridge test pass at extreme situation.
- An anti-backflow unit to prevent water from flowing back into the instrument and damaging the sensor.
- Genuine Windows 10 IoT operating system, 16 GB RAM, and 512 GB storage, ensuring smooth performance.
- Integrated touchscreen featuring anti-glare and anti-fingerprint properties.
Testing security
- The entire instrument features an IP54 protection rating, reducing the risk of cross-contamination during transfers between clean areas.
- It supports username/password login with 4-level administrative permissions, compliant with FDA 21 CFR Part 11 requirements.
- It is equipped with a comprehensive audit trail function that logs operational activities, meeting data integrity requirements.
- Its metal housing provides robust protection for the instrument core and maintains a stable operating temperature.
Convenience
- Easy to carry with 9.2 kg machine weight.
- 13.3" HD HMI and 1920*1080 resolution for easy operation and remote monitoring.
- Simplified operation interface to reduce repetitive input.
- Rich data interfaces: Ethernet port, RS232 serial interface, USB interface; capable of printing and exporting test results independently.
Reliability
- Adopt 1‰ of full-scale high-precision digital pressure sensor to ensure high accuracy and repeatability of the test results.
- Run self-test before every function tests to avoid distortion of test data caused by human installation errors.
- Each test point is accurately displayed to ensure the test curve accurac.
Dolintestor FT 4.0 Specifications
Basic Information
- Series: Dolintestor FT 4.0
- Dustproof Grade: IP54
- Power: AC100-240V, 50/60HZ, 110W
Computer
- Operating System: Win10 IOT Enterprise
- Display: Type: Color touchscreen; Size: 13.3 inches; Resolution: 1920*1080
- Serial port connection: Ethernet port; RS232; USB port; Wi-Fi; remote system updates and remote fault diagnosis
Dimension / Weight
- Dimension/mm: 367258138 (LWH)
- Weight/kg: 9.2
Testing Performance
- Max. Operating Pressure: 8000mbar
- Min. Inlet Pressure: 100mbar
- Testing Function: manual bubble point test / basic bubble point test / enhanced bubble point test / diffusion flow test / water intrusion test / pressure decay
- Testing Scope: Bubble Points 100-7000mbar; Diffusion Flow ≤0.01-4800mL/min; Water Intrusion ≤0.001-100mL/min
- Testing Accuracy: Bubble Points: ±50 mbar; Enhanced bubble point: ±50mbar; Diffusion Flow: ±5% or 0.05 mL/min (whichever is greater); Water Intrusion: ±5% or 0.05 mL/min (whichever is greater)
- Applicable Range: Symmetric and asymmetric membranes, needle filters, disc filters, capsule filters, flat filters, cartridge filters, ultrafiltration membrane cartridges, hollow, virus removal filter
Data Management
- Pre-storage program: max. 10000 pre-storage programs
- Data storage: max. 500000 test results storage
- Users: 1000 user accounts
- Administrative privileges: Username-password login with 4 levels of administrative permissions, compliant with FDA 21 CFR
- Audit trail: Multiple event logs, exportable in a non-modifiable format, meeting data integrity requirements
- Data export: Individual export of PDF files or batch export of PDF files supported
- Data backup: Supports export to USB drive
Operating Conditions
- Environmental requirements: Environmental temperature: +5°C to +40°C; Relative humidity: 10% to 80%
- Suitable Environment: Grade D or above
Additional Configurations
- Method: Online / Offline
- Language: Chinese / English / Russian / Japanese / Korean / Portuguese
- Print: Built-in micro printer
- E-Signature: Supports manual or electronic signatures
ORDERING INFORMATION: P/N 608.0000183
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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