Versatile single-use solutions for processing, storing, and transporting biopharma fluids with precision, integrity, and seamless operations in varied applications.
Multiple configurations for various processes and applications Compatible with sterile connection and disconnection devices Quick connects for easy attachment or adaptation to various connections. Tri-clamps ensure compatibility with standard production environments
Compliance
Comprehensive testing including biological, chemical, and physical tests ISO11137 compliant for validated sterility claims
Manufacturing Environment
Manufactured in ISO Class 7 cleanrooms
Volumes
50L, 100L, 200L, 500L, 1000L, 2000L
Tubing Material
TPE and Silicone
Connector options
MPX Couplings, Female Luer Lock, MPC Male Coupling, Tri-Clamp, Needle free sampling port
Compliance
Manufactured in a controlled environment (Class 10,000) Manufactured under Quality Management System certified to ISO 9001Validation includes testing for: Integrity testing, Validation Guide for Bag film & Bag Assembly
Sterilization
Gamma irradiation, 25-40 Kgy
Manufacturing
Under cGMP protocols in ISO Class 7 cleanroom conditions.
Traceability
Full traceability of all components.
Packaging
Clean and double-bagged. Packaging has labels with: gamma indicator, SKU, description, expiration date and batch No.