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Cameroon Integrity Test Dolintestor FT 1.0
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Product Description
Dolintestor FT 1.0 Integrity Tester is a high-quality testing instrument independently developed by Feature-tec according to the current GAMP guidelines. It ensures accurate testing of filter integrity with short testing time and high accuracy, suitable for any cleanroom environment.Dolintestor FT 1.0 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)
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Standard |
Description |
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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 |
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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
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Standard |
Description |
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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) |
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.
Testing security
- Ex "nA" explosion-proof design concept with whole machine, equipped with explosion-proof functionality, suitable for more demanding environments;
- IP64 protection rating, reducing the risk of cross-contamination during transportation across clean areas;
- Robust LINUX operating system significantly reduces the risk of virus infection after networking;
- Username-password login with 4 levels of management permissions, meeting FDA 21 CFR PART 11 requirements;
- Comprehensive audit tracking function, recording operation logs to meet data integrity requirements.
Convenience
- Easy to carry with 9.8kg machine weight
- 12" HD HMI with ±88° viewing angle and 1024*768 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 accuracy.
Dolintestor FT 1.0 Parameters
Series: Dolintestor FT 1.0
Dustproof Grade: IP64
Computer
- Power: AC100-240V, 50/60HZ, 110W
- Operating System: LINUX
- Display: Type: Color touchscreen; Size: 12 inches; Resolution: 1024*768
- Serial port connection: Ethernet port; RS232; USB port; Wi-Fi; remote system updates and remote fault diagnosis
Dimension/Weight
- Dimension/mm: 346457308 (LWH)
- Weight/kg: 9.8
Testing Performance
- Max. Operating Pressure: 10000mbar
- 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 100-8000mbar; 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. 1000 pre-storage programs
- Data storage: max. 50000 test results storage
- Users: 1000 user accounts
- Administrative privileges: Username-password login with 4 levels of administrative permissions, compliant with FDA 21 CFR Part 11 requirements
- 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℃ to +40℃; Relative humidity: 10% to 80%
- Suitable Environment: Grade D or above
Method: Online / Offline
Language: Chinese / English / Russian / Japanese / Korean / Portuguese
Print: Print test results and test curves
E-Signature: Supports manual or electronic signatures
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