Designed to be integrated into your downstream bioprocess, the SciLog® NFF+ 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 and Benefits
• Configurable recipe creation to control the process
• SIEMENS TIA Portal based control system
• Fully automated, on-board PUPSIT (diffusional flow)
• 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-friendly workflow
• 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)
• Adaptable for redundant filtration
Funtionality
The SciLog® NFF+ is an advanced offering enabling customization for valve and tubing size to achieve higher flow rates with developed system design compared to the SciLog® NFF System, which provides a simplified solution for filtration.
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 understand their 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 implementation 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+ with redundant filtration offers and integrated solution, with designated flow path.
