Eliminate production stoppages for sterilization, reduce the risk of contamination, and increase efficiency by incorporating Single-Use Systems. Single Use Systems, or SUS, simplify cleaning validations—use once and discard.
Each system is custom made using platinum-cured, Class VI silicone tubing or reinforced hose or or AdvantaFlex® Class VI biopharmaceutical grade tubing to meet sealing and welding application requirements. Add fittings, stoppers and container closures, filters, sensors, bottles, labels, tracking options and other components.
Single use systems are not intended for implantation or continuous steam applications.
KEY FEATURES
- Custom manufactured and assembled from a variety of components
- Reduces end-user assembly labor expense and time
- Reduces cross contamination risks
- Saves energy and resource costs by eliminating cleaning and autoclaving
- Reduces production downtime by eliminating certain cleaning validation requirements
- Provides flexibility and speed in facility design—system redesigns are implemented faster than with hard piping
- Less costly process development and design compared to systems of hard piping
- Assembled and packaged in ISO Class 7 clean rooms
- Available with validated sterility assurance of 10-6 per ISO 11137 method VDmax 25
- Documented lot traceable with identification on packaging
- Documented quality control per ISO 9001:2015
- Experienced engineers available for technical assistance
- Tubing and molded connections provide a single, animal-derived ingredient-free material contact surface
- Complete validation package available upon request
- Optional RFID tags easily attach to assemblies for identification purposes—provide reliable electronic data storage and current status of assemblies from inception to disposal
- Most silicone and thermoplastic elastomer compounds used to make Single-Use Systems have a Master File with the U.S. Food and Drug Administration