中文
Feature
- 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
Advantage
- 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
Efficient, compliant single-use system integrity testing solutions — built on industry best practices and process-specific needs.
- 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