Integtest™ v4.0 Fully Automated Filter Integrity Tester
| [Origin | Beijing, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (PRC) |
| Model | Integtest™ v4.0 |
| Price | USD 5,300 (FOB Beijing)] |
Overview
The Integtest™ v4.0 Fully Automated Filter Integrity Tester is an engineered solution for quantitative integrity verification of hydrophobic and hydrophilic membrane filters used in sterile pharmaceutical processing. It operates on three internationally recognized physical principles: bubble point (BP), diffusion flow (forward flow), and pressure hold (decay), all compliant with regulatory expectations outlined in USP , ASTM F838-22, ISO 13408-2, and EU Annex 1. Critically, the v4.0 introduces a validated water intrusion test (WIT) mode—eliminating reliance on hazardous organic solvents (e.g., isopropanol or ethanol) for hydrophobic filter wetting. This capability aligns with ICH Q5A(R2) and green chemistry initiatives while maintaining correlation to bacterial retention performance per PDA TR26 and FDA Guidance for Industry (2022). The instrument employs a closed-loop pneumatic architecture with digitally controlled mass flow regulation, ensuring repeatable gas delivery across variable filter geometries—from single-disc membranes to multi-cartridge assemblies up to 15 elements.
Key Features
- Water Intrusion Test (WIT) mode: Enables aqueous-based integrity testing of hydrophobic filters without solvent handling, reducing operator exposure and waste disposal complexity.
- Automated, standardized wetting protocol: Precisely controls liquid saturation kinetics to ensure complete pore filling while preserving downstream sterility—validated for in-line use per ASME BPE-2022 Section 6.4.
- Adaptive signal processing engine: Dual-core real-time acquisition continuously analyzes transient diffusion flow profiles; proprietary filtering algorithms distinguish viscous flow from true diffusive gas transport, improving bubble point endpoint resolution.
- Digital pressure control system: Replaces manual analog regulators with servo-driven solenoid valves, delivering ±0.5% setpoint stability across the full 500–6900 mbar test range.
- Multi-element scalability: Optimized flow path design maintains measurement fidelity for large-diameter (up to 300 mm) disc filters and multi-cartridge housings (2.5″–40″, 1–15 cores) without recalibration.
- Enhanced safety architecture: All critical components—including pressure transducers, relief valves, and electrical isolation—meet IEC 61010-1:2010 Class II requirements; overpressure protection limits test pressure to ≤110% of user-defined maximum.
Sample Compatibility & Compliance
The Integtest™ v4.0 supports integrity evaluation of all common pharmaceutical-grade filtration configurations: disc membranes (Φ25–Φ300 mm), standard cartridge filters (2.5″–40″), capsule filters, mini-cartridges, and vent filters. It satisfies data integrity requirements under FDA 21 CFR Part 11 through role-based user authentication (three-tier access: Operator, Supervisor, Administrator), audit-trail-enabled event logging, and electronic signature support in optional software packages. Test reports include timestamped metadata, environmental conditions (ambient T/RH), raw sensor traces, and pass/fail determinations against configurable acceptance criteria—fully traceable for GMP audits and regulatory inspections.
Software & Data Management
The embedded 5.7″ monochrome TFT display provides real-time visualization of pressure curves, flow rate trends, and pass/fail status during execution. RS232 serial interface enables integration with LIMS or MES systems. Optional PC-based IntegSoft™ v4.0 software extends functionality with: automated report generation (PDF/CSV), historical trend analysis across ≥1000 test records, comparative batch-to-batch statistical summaries (mean, SD, %RSD), and configurable electronic signatures compliant with ALCOA+ principles. All data files are cryptographically hashed to prevent tampering; backup archives support external USB storage.
Applications
- Sterile drug product final filtration validation (e.g., biologics, parenterals)
- Aseptic process air filtration integrity (vent filters, tank breathers)
- Purified water and WFI distribution loop point-of-use filters
- Single-use bioprocessing assemblies (SUTs) with integrated filters
- Pre-sterilization filtration of cell culture media and buffers
FAQ
Does the Integtest™ v4.0 meet FDA 21 CFR Part 11 requirements?
Yes—when used with IntegSoft™ v4.0 and configured with enabled audit trail, electronic signatures, and role-based permissions.
Can it perform Water Intrusion Test (WIT) on PTFE or PVDF hydrophobic filters?
Yes—WIT is validated for standard 0.2 µm and 0.1 µm hydrophobic membranes per ASTM F2721-21 Annex A2.
What is the maximum allowable test volume for diffusion flow measurements?
The system accommodates total upstream volumes up to 15 L without loss of accuracy; calibration is independent of housing geometry.
Is hardware calibration required annually?
Field calibration is not mandatory; however, annual verification using NIST-traceable pressure standards is recommended per ISO/IEC 17025.
Does the instrument support GLP-compliant documentation?
Yes—integrated printer outputs fully annotated reports including operator ID, equipment ID, environmental data, raw curves, and compliance statements.
