What about leak resistance? As you have made changes to reduce leachables how has this impacted the strength of the bags?
In order to ensure a film will have optimal strength for bioprocess applications, the polymer resins and additives must be carefully selected and optimized. A combination of chemistry, biology, and engineering design factors must be considered to achieve the critical to quality attributes of a bioprocess film.
In the case of Bioclear™11, specifically designed for Wave™ Bioreactors, the concentration of the antioxidant tris(2,4-di-tert-butylphenyl)phosphite) was lowered to reduce the level of extractables. However, extensive testing was done to confirm the reduction in antioxidant concentration did not impact the form, fit, or function of the film. The physical properties of the film, such as tensile strength and modulus, are unchanged. For more details about the comparability study of our Bioclear™ films, click the link below.
Film selection for bioprocess applications requires consideration of how the design of the film influences the chemical, biological, and engineering performance attributes. At GE Healthcare, through collaboration with our Global Research Centers, we draw upon our strong foundation of material science knowledge and combine it with our understanding of bioprocess application to advance our scientific acumen in film development.