SCILOG® NFF+ PF

Automated NFF with PUPSIT capabilities.

Product Documents

SCILOG® NFF+ PF

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Description

SciLog® NFF+ PF: Automated Normal Flow Filtration System with PUPSIT

The SciLog® NFF+ PF is a fully automated Normal Flow Filtration (NFF) system designed for final fill and bulk fill applications in GMP-compliant bioprocessing environments. Engineered to support compliance with EU GMP Annex 1 (2022), this system features integrated Pre-Use Post-Sterilization Integrity Testing (PUPSIT) to meet regulatory expectations and enhance process control.

Key Features and Benefits:

  • Automated PUPSIT Functionality
  • Validates filter integrity before product filtration, ensuring compliance and product safety.
  • Compact GMP Footprint
  • Designed to seamlessly integrate into cleanrooms and tight production spaces without compromising performance.
  • Single-Use Technology and Automation
  • Combines disposable sensing components with an automated workflow to minimize operator error and increase reproducibility.
  • Configurable Process Control
  • Real-time monitoring and adjustment of pressure and flow rate help optimize filtration efficiency, reduce processing time, and extend filter life.
  • Custom Manifold Design
  • Supports the integration of validated process components into a compact, tailored configuration to meet your unique workflow needs.

Designed for Seamless PUPSIT Integration

Implementing PUPSIT can present challenges such as limited cleanroom space, retrofitting constraints, and validation requirements. The SciLog® NFF+ PF is engineered to simplify PUPSIT integration, offering a compact and configurable solution that supports compliance without disrupting your workflow. Whether you’re updating an existing process or launching a new production line, this system is built to help ease adoption and improve operational efficiency.

Additional information

Markets

Biopharmaceutical

Features

Features and Benefits

  • Configurable recipe creation to control the process
  • SIEMENS TIA Portal based control system
  • On-board integrity testing capability
  • GMP compliance, including FDA 21 CFR Part 11 and EudraLex Annex 11
  • Adheres to the S88 standard for effective batch process control
  • Touch-screen HMI with intuitive graphical interface
  • Manual mode control through HMI
  • User configurable alarms and interlocks
  • Communicate real-time process parameters via OPC to a plant historian and integrate with local active directory, or operate as a stand-alone unit
  • Up to two integrated scales for highly accurate filtration endpoints (optional)
  • Redundant filtration variant available (SciLog® NFF+ PFR)
  • Manifold leak test on installation
  • PUPSIT to validate filter integrity directly before processing
  • Post-use testing to validate filter integrity after the process
  • User-friendly workflow
  • Designed to mitigate operator error