1X PBS (Phosphate Buffered Saline) Buffer Mixing Optimization

This study develops optimal process conditions for mixing and filtering of 1X PBS buffer using the 50 L, 200 L, and 1000 L Mobius® Single-Use Mixing Solution, Durapore® and Millipore Express® filters.

The Mobius® Single-use Mixing Solution delivers advanced technology for mixing pharmaceutical ingredients from intermediate to final drug products and for the preparation of process solutions, such as buffers and media. Each single-use mixing container includes a magnetically-driven levitating impeller for improved mixing consistency and efficiency. The Mobius® Single-use Mixing Solution includes a powder delivery system, 10 L, 50 L, 100 L, 200 L, 500 L, and 1000 L single-use mixers and the Mobius® FlexReady Solution for Buffer and Media Preparation.

Durapore® 0.22 μm, Millipore Express® SHC (0.5/0.2 μm), and Millipore Express® SHF (0.2 μm) sterilizing-grade filters were used in this study. Durapore® filters contain polyvinylidene fluoride (PVDF) membrane and Millipore Express® filters contain polyethersulfone (PES) membrane. These sterilizinggrade membranes are offered in capsule and cartridge formats in a variety of pore sizes to meet different sterility assurance needs. The capsules are gamma and autoclave compatible and can be purchased gamma sterilized. The gamma compatible capsules are incorporated directly into the disposable Flexware® assemblies of the Mobius® FlexReady Solution for Buffer and Media Preparation, resulting in a sterile, fully-closed flowpath.

Many of our buffer products bear the Emprove® Expert and Emprove® Essential trademark. The Emprove® product lines have been developed to make work safer, faster and more cost-efficient, and offer regulatory documentation that strengthens the quality section of registration dossiers.