Lifecube SAP PUPSIT System, SAP, PUPSIT (CAT#: STEM-BC-0104-ZJF)

The Lifecube SAP PUPSIT system is a tubing system designed for pre-use post-sterilization integrity testing of sterile filtration processes. It supports PUPSIT requirements for sterilizing-grade filters before use while maintaining system sterility before and after testing. The system can be configured for single-stage filtration, dual-stage filtration, and redundant filtration arrangements. It uses disposable assemblies such as capsule filters, storage bags, tubing, aseptic connectors, adapters, branch connectors, instrument fittings, pressure sensors, and monitoring devices. The design considers process factors such as preflushing, product flush, process pressure, gas supply, water supply, tubing length, and bag volume. Standard, configure-to-order, and engineer-to-order options support different process layouts. The system can be used for high bubble-point filter PUPSIT. Preirradiated sterile packaging supports cleanroom transfer requirements.

Application: Terminal sterilizing filtration
System type: Single-use PUPSIT tubing system
Filter configurations: Single-stage, dual-stage, redundant filtration
Packaging: Preirradiated double sterile packaging with optional triple packaging
Production environment: Quality Management Standard 4.8 cleanroom
Integrity testing: 100%
Endotoxin level: <0.25 EU/mL
Biocompatibility: USP <87> and USP <88> Class VI
Particulate compliance: USP <788>
Gamma irradiation validation: Quality Management Standard 11137
Verification tests: Leak test, pressure resistance test, connection strength test

Supports EU quality manufacturing standard Annex 1 PUPSIT requirements
Maintains sterility before and after filter testing
Flexible standard and custom configurations
Supports high bubble-point filter testing
Precleaned flushable assemblies reduce particles and extractables
Multiple disposable component options
Validation and use documentation available
Suitable for terminal sterilizing filtration workflows

STEM-BC-0246-ZJF