Ultra- and Diafiltration (TFF)

As part of the expansion of production capacity at the Broadmeadows (Au) site, three new cross-flow filtration (TFF) systems were installed for the purification of human immunoglobulin. In ultrafiltration, the product solution is concentrated by continuously withdrawing the filtrate. In diafiltration, the amount of filtrate withdrawn is replaced by the same amount of another buffer. The units are designed as skid units and were delivered completely prefabricated. A maximum filtration area of 120m2 can be set up for large-volume processing of protein solutions. All equipment can be cleaned inline using CIP and sanitized using clean steam. The filter membranes are cleaned using a high-purity alkaline cleaning solution.

With a few exceptions, the plants were designed and built identically to the plants at the Bern site. Accordingly, the customer-specific requirements such as installation type, pump type and sanitization had to be met again. TTSol was entrusted with the project as an experienced and reliable partner of the customer. The plant technology was successfully planned and implemented in accordance with the high GMP requirements.