BIOT 486 |
| Filters are extensively used in Biotechnology Manufacturing for a multitude of purposes. Filtration costs can be significant but can be reduced and process consistency enhanced by using the same filters multiple times. Regeneration of filters is typically performed by water regeneration and/or chemical regeneration. In this study, a systematic series of statistically designed experiments were performed to understand the impact of dirty hold time, temperature, concentration of cleaning agent (caustic), and caustic hold time on the regeneration of a microfiltration filter. A central composite design (CCD) design was used to develop an efficient design in response surface approach to process optimization. The practical deployment of a CCD is through sequential experimentation. The first step is factorial design plus execution of center runs (experiments). In this study, microfiltration membranes were soiled with product, and then held for a defined amount of time before being regenerated with varying cleaning agent concentrations and at different temperatures. The success of regeneration was evaluated through % recovery of Normalized Water Permeability (NWP) (post-regen vs. new filter pre-use). The results were used to determine the trend of different variables on the filter regeneration. Results from this study demonstrate that the temperature of the cleaning agent is the most important parameter for the filter regeneration followed by the cleaning agent concentration with minimal impact of cleaning agent hold time for the soil and filter studied. The implementation of the optimum regeneration conditions in production results in significant savings both in terms of product cost and enhanced cycle time. In addition, the optimum regeneration condition will provide the most robust process for achieving a greater number of filter uses during subsequent extension of filter re-use validation. The results from this study demonstrate the feasibility of using the same filter for multiple uses without effect on the product quality. |
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Poster Session
5:30 PM-7:30 PM, Wednesday, August 22, 2007 BCEC -- Exhibit Hall - B2, Poster
Division of Biochemical Technology |