SciLog^® NFF+ PS Semi-Automated NFF System with PUPSIT

The SciLog^® NFF+ PS is a versatile, semi-automated normal flow filtration (NFF) skid designed to simplify critical filtration processes and support regulatory compliance within GMP cleanroom environments. Developed to meet the updated EU GMP Annex 1 (2022) requirements, the NFF+ PS streamlines the execution of Pre-Use Post-Sterilization Integrity Testing (PUPSIT) for final fill and bulk filter operations—a crucial measure for product safety and sterility in life sciences applications.

Leveraging a robust SIEMENS TIA Portal-based control system, the NFF+ PS enables technicians to select essential process steps directly via a touch-screen HMI interface, ensuring repeatability and reducing risk from manual intervention. This system features pneumatically actuated valves, establishing reliable, operator-selected flow paths for essential filtration tasks, including intuitive manifold installation, line priming, filter wetting, product filtration, and both pre- and post-use integrity testing.

The system is engineered for integration with external integrity testers and process pumps, making it ideal for upgrading legacy batch filling operations to current standards. Available in both standard and redundant (SciLog NFF+ PSR) configurations, the NFF+ PS supports redundancies that mitigate the risk of batch loss and optimize resource use. Compact, mobile, and constructed for cleanroom compliance, it offers end-users a scalable solution that minimizes validation burden and process risk.

Designed with error-proofing in mind, the NFF+ PS enhances process visibility, improves fluid/air management, and supports traceable, stepwise compliance in bioprocessing environments. Parker’s modular manifold approach even allows for bespoke, gamma-sterilized, single-use manifolds, optimizing for low hold-up volume and compatibility with customer-validated components.

Features

• Semi-automated normal flow filtration system with PUPSIT functionality
• Intuitive, touch-screen HMI with graphical interface
• SIEMENS S7-1500 controller with TIA Portal environment
• Pre-programmed valve controls for common fill/filtration steps
• Pneumatic actuated valve system ensures correct process flow path
• Compatible with external integrity testers and pumps
• Visual valve position indicators (open/closed)
• User-configurable alarms and safety interlocks
• Closed-system design suitable for GMP cleanroom environments (IPx5)
• Supports batch record compliance and error-proofing for regulatory processes
• Redundant (dual) filtration model available for critical fill (SciLog NFF+ PSR)
• Compact, mobile 316L stainless steel platform (304L body available)
• Customizable, gamma-sterilized, single-use manifolds (ISO 11137)