Product Description
The castus® Single Use (CSU) is a purpose-built single-use beta bag system designed for the sterile transfer of components into and out of isolators in contamination-controlled pharmaceutical environments.
Developed for modern aseptic manufacturing requirements, CSU combines engineered sealing technology, robust material design, and flexible configuration options to support secure, reproducible transfer processes.
Designed with process relevance in mind, the system addresses increasing demands for contamination control, operational efficiency, and compliance with evolving regulatory expectations such as EU GMP Annex 1.
Designed for sterile transfer. Built for flexible processes.
Main Features and Benefits
- Injected silicone gasket to prevent gaps
- Specialized heat-sealed POE ring connection creating a reduced leakage risk compared to mechanical clamping
- Bottle neck design to minimize residual residue and improved emptying efficiency
- Available in Tyvek®/HDPE and PE/EVOH/PE constructions
- Volume range from ~5L to 80L
- Optional chute assemblies and handling accessories
- Multiple workflow-oriented configurations
- Compatible with common sterilization methods:
- Gamma (≥ 25 kGy)
- Steam sterilization
- ETO
- X-ray
- VHP-resistant design
- Optional RFID integration for identification and tracking
- Produced in cleanroom environments (ISO Class 5 at rest)
- 100% leak testing of every unit
- Full batch traceability and documented IPC controls
- Supports small-batch and flexible manufacturing trends
- Enables faster implementation of new processes
- Aligns with industry shift toward single-use systems
