As part of the expansion of production capacity at the Bern 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 In diafiltration, the amount of filtrate withdrawn is replaced by the same amount of another buffer.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.
For the design and construction of these plants, various customer-specific requirements had to be met, such as installation type, pump type and sanitization. TTSol was commissioned with the project as a long-standing and reliable partner of the customer. The plant technology was successfully planned and implemented in accordance with the high GMP requirements.
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