Designed to be integrated into the downstream bioprocess, the SciLog® NFF+ range supports compliance to EU GMP Annex 1 (2022) for final fill and bulk filling applications.
The SciLog® NFF+ PM is a stand-alone unit for intuitive installation of the manifold and handling during the bioprocess. This enables efficient filtration and supports the execution of pre-use post-sterilization integrity testing (PUPSIT) and post-use integrity testing of the sterilizing filter.
The mobile solution requires the use of an external integrity tester, pressure monitoring, and pump.
Features
• Manual valve control
• Configured to support the manifold in a vertical position, with tube and component supports
• Designed in a compact footprint
• To be used in-line with GMP manufacturing
• Castor mounted and fully mobile
• Redundant filtration variant available (SciLog® NFF+ PMR)
Benefits
• Intuitive installation and operation – with upright support unit
• Complete process visibility
• Simple integration into current process
• Closed system designed for the cleanroom
• Upstream component supports positioned to minimize air traps
PUPSIT Support & Consultancy
Parker understands 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 with automation and single use technology.
Customization
If your process is validated with specific components, we aim to support their integration into the design, where possible. The manifold can be designed within the footprint of the system.
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 an additional complexity with the added flow paths and connections. The SciLog® NFF+ PMR with redundant filtration offers an integrated solution, with a designated flow path.
Single-Use Manifolds
Parker offers a portfolio of components to develop a single-use solution suited to your process. This can be designed in tandem with your SciLog NFF+ system solution to ensure effective processing and liquid handlings. Design factors include low hold-up volume, upstream/ downstream sampling, integrated waste bag etc.
Support Included with System
• Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) – where applicable
• User training, if required
• Installation, operation and maintenance instructions
• Material certificates
• Hardware Design Specification (HDS)
Additional Support Options
• Retro-fitting and process validation support
• Servicing
•On-site training
• IQ/ OQ / PQ document package(s)
• IQ/ OQ execution
