Implementation of a New Membrane and the Re-use in a Tangential Flow Filtration System
Abstract
Tangential Flow Filtration (TFF) is
commonly used as the last steps in protein
purification processes at Biopharmaceutical Plants
for clarification and concentration of the target
protein. Since the membranes are expensive, the
industries should maximize its use in order to
minimize associated costs. A common membrane is
made Polyethersulfone. As specified from the
manufacturer, it can be cleaned using Sodium
Hypochlorite (NaOCl). Since TFF is the last step
in the manufacturing process, a Biopharmaceutical
Plant have the concern of using this cleaning agent
since this solution can alter adversely the safety,
identify, strength, purity and quality of the product.
For this reason, it was chosen not to validate a
cleaning strategy for Polyethersulfone TFF
cassettes in a specific industry. Instead, new
membranes are installed for the manufacturing
process per production lot. A typical cost of
membrane ranges between $5,000 and $7,000. For
a process that requires eight membranes, the cost
for a biotechnology plant is approximately $40,000
per lot. This proposed project consists in changing
Polyethersulfone membranes to Regenerated
cellulose, which can be easily cleaned with sodium
hydroxide, commonly used in pharmaceutical
industry. By demonstrating the effectiveness of
membrane reuse via cleaning validation, a typical
biotechnology industry can save more than $2
million in an annual basis.
Key Terms - Biopharmaceutical, Cleaning,
Membranes, Tangential Flow Filtration.