Extractables Analysis of Flexboy® Bags Filled with Buffer Solutions

Sartorius has developed a new polyethylene film and bioprocessing bags to facilitate the way towards the single-use facility of the future. Flexsafe meets the most stringent needs for safer bioprocessing. Flexsafe bags ensure an excellent and reproducible growth behavior with the most sensitive production cell lines. The optimization of the resin formulation and the complete control of our raw materials, the extrusion process and the bag assembly guarantee a consistent lot-to-lot cell growth performance.Flexsafe meets your requirements for outstanding robustness and ease of use at all steps of your manufacturing process. The film’s strength and flexibility provide consistent performance and easy handling – even in the most stringent applications like cell culture, long-term storage or shipping of drug products.To meet the highest business continuity requirements, we have a robust contingency plan for our Flexsafe bags in place. The uninterrupted film supply is based on redundant resin crackers, film extrusion lines and multiple manufacturing sites.The complete range of scalable Flexsafe bags enables you to implement single-use bioprocessing throughout all steps of drug manufacture, from process development to production – all using just one film.Features: Optimized antioxidant package - Excellent cell growth of the most sensitive cells Use of pharmacopeia-listed antioxidants only - Simplified toxicology assessment Zero slipping agents - No risk of interference due to these agents Mechanical anti-blocking - Reduces stickiness, facilitates extrusion and bag handling Meaningful specifications and process control from polymer resin to finished bag Reliable and reproducible growth performance, well-characterized extractables profile