How can we minimize the use of stainless steel tanks and reduce the buffer batch preparation required for each lot of our plasma product?
Due to the broad need for buffer solutions
throughout a plasma manufacturing process, buffer filtration is typically a high volume operation. Thus, efficient sterile filtration of buffer solutions is critical to ensure a successful and timely batch operation. Our dedicated team of experts started the project by running Vmax™ studies on the customer’s buffers, in triplicate. The Vmax™ method is commonly used in a variety of applications to estimate filter size requirements for normal flow membrane filters. Based on the study results and superior performance in similar applications, we recommended Millipore Express® PHF
filters attached to 10, 20, 50, 100, 200, and 1000 L single-use bag assemblies. These assemblies included Mobius® 2D bags
and Lynx® S2S
connectors. To allow for one filter to fill several bags, filters were not built into the assembly.
Once these new assemblies were implemented, the customer was able to make larger batches of buffers that could be used over multiple lots of product, increasing process efficiency and decreasing time and cost associated with cleaning of tanks and intensive buffer preparation. The consistent communication from our on-site team continues to provide the customer with simple order tracking and assurance that everything will arrive on time.
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Read this application note about sizing methods: