SciLog® NFF+ PF Automated NFF System with PUPSIT
Product Description
The SciLog® NFF+ PF is an advanced, automated normal flow filtration (NFF) system designed to streamline and secure bioprocessing workflows, particularly in bulk filtration and final fill applications. Developed for compliance with EU GMP Annex 1 (2022), this system uniquely integrates Pre-Use Post-Sterilization Integrity Testing (PUPSIT) directly into the automated sequence, helping customers meet the latest regulatory requirements for critical fill-finish operations.
Combining robust automation with intuitive operator controls, the NFF+ PF system minimizes user error and supports Good Manufacturing Practice (GMP) environments. Its Siemens TIA Portal-based control platform oversees configurable recipes, real-time process parameter monitoring, and comprehensive batch recordkeeping to optimize filtration outcomes and simplify validation. The operator is guided step-by-step— from hardware verification and manifold leak testing to PUPSIT execution, product filtration, and post-use integrity testing.
Customizable to match specific process needs, the system integrates seamlessly with plant historians and supports single-use and fixed membrane pressure sensor options. Its compact, mobile stainless-steel enclosure ensures suitability for cleanroom environments while facilitating ease of maintenance and system maneuverability.
The NFF+ PF system is available in both standard and redundant filtration configurations (SciLog NFF+ PFR variant), offering built-in risk mitigation for the most sensitive sterile filtration processes. With extensive documentation, validation support, and comprehensive training provided, the SciLog NFF+ PF helps reduce compliance risk, increase operator confidence, and protect product integrity at every stage.
Features
- Fully automated NFF system with integrated PUPSIT functionality
- Siemens S7-1500 control platform with touch-screen HMI
- Compliance with FDA 21 CFR Part 11 and EudraLex Annex 11
- Supports GMP environments and batch process control (ISA S88 standard)
- Operator-guided workflow with real-time monitoring and active directory integration
- Configurable recipes for process optimization
- Up to two integrated scales for high-precision fill endpoints (optional)
- Available with redundant (dual) filtration for critical applications
- Manual mode operation and user-configurable alarms/interlocks
- Data communication via OPC/Ethernet for plant historian integration
- Mobile, cleanroom-compliant enclosure (304L SS, 316L optional)
- Supports single-use or fixed, membrane pressure sensors
- Automated manifold leak test, filter integrity testing (pre- and post-use), in-line sampling, optimized product recovery
Specifications
| Filtration Type | Automated NFF with PUPSIT (redundant option available) |
|---|---|
| Enclosure | 304L stainless steel framework (316L optional), IPx5 rating, mobile |
| Filter Size | 1” to 30” |
| Number of Product Sterilizing Filters | 1 (PF) or 2 (PFR) |
| Pressure Sensors | Up to 2 (PF) or 4 (PFR) |
| Flow Rate | 0.2 - 6.5 L/min |
| Pump Types | Peristaltic or diaphragm |
| Dimensions (W x H x D) | 1.2 x 1.9 x 0.7 m (PF), 1.5 x 1.9 x 0.7 m (PFR) |
| Control | Siemens TIA Portal, S7-1500 |
| Connectivity | Ethernet port, OPC, connections for 2 x scales |
| Operational Modes | Constant flow, constant pressure, R/P Stat, manual |
| Certifications | FDA 21 CFR Part 11, EudraLex Annex 11 compliance |