Parker SCILOG® NFF+ PS  semi-automated normal flow filtration system with PUPSIT for GMP bioprocessing applications

SCILOG® NFF+ PS

Semi – Automated NFF with PUPSIT capabilities.

Product Documents

SCILOG® NFF+ PS

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Description

SciLog® NFF+ PS – Semi-Automated Normal Flow Filtration System with PUPSIT

The SciLog® NFF+ PS is a versatile semi-automated Normal Flow Filtration (NFF) system designed to support pre-use and post-use filter integrity testing in GMP-compliant bioprocessing environments. Developed for final fill and bulk fill applications, it helps ensure compliance with EU GMP Annex 1 (2022) requirements by facilitating reliable PUPSIT (Pre-Use Post-Sterilization Integrity Testing).

Additional information

Markets

Biopharmaceutical
Features

Features and Benefits

  • SIEMENS TIA Portal based control system
  • Pre-defined options for valve control for final fill process steps, including PUPSIT and post-use integrity
    testing
  • Execute PUPSIT as part of the sequence before continuing to product processing
  • Visual indicator for valve positioning (open / closed)
  • Touch-screen HMI with intuitive graphical interface
  • User configurable alarms and interlocks
  • Supports the use of an external integrity tester, pressure monitoring and pump
  • Redundant filtration variant available (SciLog® NFF+ PSR)
  • Improved efficiency with intuitive manifold installation and programmed process operations.
  • Error-proofing approach and complete process visibility
  • Process step selection supporting automated valve control for simplified process operation and minimizing human error
  • Supports use of an external integrity tester enabling the use of validated equipment.
  • Sterilizing filter can be integrity tested and validated on the system, before proceeding to filtering; or integrity testing the sterilizing filter post-use directly on the
    system / in the assembly – optimizing process steps/resource and minimizing risk of batch losses.
  • Closed system designed for the cleanroom.