Challenges & Advances in Cleaning Ultrafiltration Membranes

Challenges and Advances in Cleaning Ultrafiltration Membranes

Extended Learning
Learning Level: Intermediate
Time: 1100 – 1200 ET
Session Length: 1 hour

Concentration/Ultra-filtration (CUF) membranes are used extensively in biopharmaceutical operations. A typical purification platform may incorporate two to six CUF steps though out the downstream process. Customarily, these membranes are cleaned using 0.1 – 0.5 N Sodium hydroxide (NaOH) or dilute solutions of Sodium hypochlorite (NaClO). These solutions are chosen due to recommendations from the membrane manufacturer or what has been historically performed on site. The cleaning process is challenging and does not make allowances for the residue being cleaned, only the compatibility of the cleaning agent on the membrane. By not considering the residue and how to effectively remove it from the surface, the end user is left with an inefficient cleaning process at best. Inefficient cleaning of UF membranes leads to a reduction in membrane cycles, or re-use rate, an increased water consumption, lower product yields, increased risk for microbial contamination and an increase in concentration/ultra-filtration processing times.

This presentation will propose a method to evaluate formulated cleaning agents commonly used on stainless steel surfaces for cGMP cleaning applications to demonstrate they may also be suitable for cleaning select CUF membranes. The speaker will discuss performing feasibility testing to compare cleaning methodologies, demonstrating a correlation to lab evaluations on a representative surface, outline best practices for assessing the efficiency of ultrafiltration membranes and describe alternative methods for cleaning leading to increased cycle lifetime and an average of 40% less water usage for rinsing. Attendees will better understand ultrafiltration cleaning challenges, how to clean using alternative methods and how to demonstrate the membrane has been cleaned effectively.

Learning Objectives

1. Cleaning of Filtration membranes in Biopharma
2. Understand how to monitor UF membranes for cleanliness
3. Fundamental Elements of Effective Cleaning design

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Speakers

Beth Kroeger

Technical Services Senior Manager

Steris Corp.