Designed to be integrated into your downstream bioprocess, the SciLog® NFF+ range 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 system supports the use of an external integrity tester and pump, incorporated within the compact footprint for GMP operating environments.

Features

• Configurable recipe creation to control the process
• 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)

Benefits

• Intuitive manifold installation and process operation
• Complete process visibility
• Process step selection— supporting automated valve control for simplified process operation and minimizing human error
• Supports use of external integrity tester— enables use of validated equipment in configuration with a manual support unit
• 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
• Closed– system designed for the cleanroom.

Redundant Filtration

Redundant sterile filtration is employed to mitigate the risk of post-use filter integrity test failure in the primary sterilizing filter. The incorporation of redundant filtration creates an additional complexity with the added flow paths and connections. The SciLog® NFF+ PSR with redundant filtration offers an integrated solution, with designated flow path to reduce the associated complexities.

Customization

The manifold can be designed within the footprint of the system, configured to ensure a low hold up volume. If your process is validated with specific components, we aim support their integration into the design, where possible.

 PUPSIT Support

Parker understand there may be challenges in the implementation of PUPSIT with retrofitting and validation, conditions of the clean room, integration and limited footprint. Parker can support with the integration of PUPSIT.

Flow Path Options

The system can be configured with defined steps and flow paths, enabling the operator to select a function to control the pneumatically actuated valves. This simplifies the execution of the filtration process ensuring the correct flow paths are always selected. The flow paths are optimized to ensure: air is effectively displaced from the system to maximize filter wetting, fluid flow is not affected by air traps, and minimize fluid hold up.

Flow paths would include your specified connections to connect to the process pump and integrity tester.

The selectable steps could include:

• Manifold installation/ uninstallation
• Line priming
• Filter wetting
• Flush to waste
• Product filtration to filling line
• Filter integrity testing, including filter wetting, pressure hold, and venting
• Upstream and/or downstream sampling
• Product recovery / blowdown

Support Included with System

• Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
• User training during FAT and SAT
• Declaration of conformity
• Installation, operation and maintenance instructions
• Pneumatics and Instrument Diagram (P&ID)
• Electrical schematic
• Critical spares list with manuals or datasheets
• Material certificates
• GAMP® document package including: Functional Design Specification (FDS), Hardware Design Specification (HDS), Software Design Specification (SDS)

Additional Support Options

• Retro-fitting and process validation support
• Servicing
• On-site training
• IQ / OQ / PQ document package(s)
• IQ / OQ execution

Please contact your local Parker representative to discuss how these systems can be configured for your needs.