Flexsafe® 2D Bags in Shell

This product is composed of Flexsafe^® 2D bags ready-to-use in a transparent protective shell for supporting all handling steps.

After filling, the bag in shell is packaged into polyethylene overpouches and then placed in a plastic box which provides the appropriate shipping solution with optimized palletization.

This logistic solution has been extensively qualified according to stringent international norms in the industry for both manual handling and transportation throughout the bag’s entire lifecycle.

Flexibility

Multiple configurations are available with bag volumes for 5L, 10L, and 20L.

Easy Implementation

Flexsafe^® 2D bags in shell are sterilized and ready-to-use. This allows for them to be easily and conveniently integrated into relevant processes. Associated systems such as trays and racks are available to facilitate bag handling.

Robust Performance and Assurance of Quality Supply

Flexsafe^® 2D bags in shell are designed for reliable storage, handling, and shipping of biopharmaceutical solutions. Flexsafe^® bags ensure consistent cell growth robustness. They are extensively validated for all process steps, from cell culture and downstream purification of drug substances to final formulation and filling of drug products. The characterization of resins and the establishment of supply contracts for the resins and the film ensure robust change control and a reliable assurance of quality supply.

Validation

Flexsafe^® 2D bags in shell have been qualified by applying comprehensive and innovative test regimes. Biological, chemical, and physical tests combined with extensive extractable testing provide users with data representing a wide range of process fluids in a variety of processing conditions. Full compliance with ISO11137 provides a validated claim of sterility for all Sartorius single-use products with a sterility assurance level of 10-⁶ over their shelf lives.

The extensive qualification of our liquid shipping solutions for Flexsafe^® 2D bags in shell 5L, 10L, and 20L ensures reliable and robust liquid handling and transportation. The Flexsafe^® shipping systems have been extensively tested against stringent international standards such as ASTM D4169, D7386 and a mix of ISO, EN or NF norms.