Designed to be integrated into your downstream bioprocess, the SciLog® NFF+ PF supports compliance to EU GMP Annex 1 (2022) for final fill and bulk filling applications. Combining single-use sensing technology and automation, the system guides the operator through PUPSIT and the bioprocess to minimize user error. The fully-automated sequence can be configured to monitor, adjust and record pressure and flow rate to optimize processing times and maximize filter life and efficiency.
The integrated PUPSIT capability allows for the integrity of the filter to be validated before progressing to product filtration.
Features
• 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 standalone unit
•Up to two integrated scales for highly accurate filtration endpoints (optional)
• Redundant filtration variant available (SciLog® NFF+ PFR)
Benefits
• 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
Functionality
The SciLog® NFF+ PF is an advanced offering, designed to provide a simplified solution for PUPSIT integration during the final fill.
Customization
The manifold can be designed within the footprint of the system. If your process if validated with specific components, we aim to support their integration into the design where possible.
PUPSIT Support
Parker understands there may be challenges in the implementation of PUPSIT with retrofitting and validation, conditions of the cleanroom, integration and limited footprint. We can support with the integration of PUPSIT.
Redundant Filtration
Redundant sterile filtration is employed to mitigate the risk of post-use filter integrity test failure in the primary filter. The incorporation of redundant filtration creates and additional complexity with the added flow paths and connections. The SciLog® NFF+ PFR with redundant filtration offers an integrated solution, with designated flow path to simplify and support PUPSIT execution.
