Features
- Sterilization: Alternative gamma irradiated or autoclaved
- 100% Integrity Test
- Expertise in PUPSIT Customization
- Flexible Component and Filter Selection
- Minimized particles and endotoxin level with patented ‘C+A’ ultra-clean assembling process
Advantages
- High Process Adaptability: Compatible with sterilizing-grade filter integrity testing across validated test pressures, filter configurations, and connection specifications, with customizable system designs.
- Controllable Cleanliness: Alternative ultra-clean production environments reduce the risk of contamination from extraneous particles and bioburden.
- Reliable Performance: Engineered to withstand integrity test pressures exceeding 4 bar, meeting stringent process requirements.
- Stable Delivery: Lot-to-lot consistency and predictable delivery cycles.
- System Integration: Deliver holistic process solutions encompassing support frames, automated systems and filling assemblies.
- Industrial Validation: Proven in commercial production, with process adaptability and reliability validated at scale.
PUPSIT Design Considerations
- Wetting fluid selection: Matched to the process fluid (drug substance, WFI, buffer) to ensure integrity test sensitivity and result reliability.
- Filter configuration and drying: Properly configure liquid/gas filters, optimize the drying process, and balance process safety, testing cycle, and product loss.
- Flow path design: It integrates pressure control, online flushing, integrity testing, backflow prevention, and waste liquid collection to construct an integrated flow path that complies with regulatory standards.
- System compatibility: Modular design, supports manual/semi-automatic/fully automatic PUPSIT solutions, and is compatible with mainstream bioprocess platforms.
PUPSIT Core Components
The PUPSIT flow path is a sophisticated closed-loop system of which the core objective is to perform online integrity testing of filters under aseptic conditions.A typical flow path consists of five key connected components, ensuring controllability and high reliability of the testing process.
- Sterilizing Filter: The sterile barrier of the process is the core object of integrity testing.PVDF and PES membrane materials are available.
- Braided Hose: Pressure resistant, low extractables, biocompatible Sterilization and Integrity Testing.
- LeSiever® Filter Integrity Tester: Supports bubble point, diffusion flow, and pressure hold methods; data is traceable and compliant with audit trails.
- Pressure Sensor: Online monitoring of system pressure ensures test stability.
- Collection Bag: Aseptic closed-loop collection of wetting/test waste liquid.
