Cleaning studies show significant cost reductions possible

Published July 18, 2018

BTEC scientist Haiwei Zhang conducts a bioburden reduction study.
BTEC scientist Haiwei Zhang conducts a bioburden reduction study by challenging a bioprocess skid with B. subtilis and cleaning the system with WFI at 80°C. Experiments were part of a three-year collaboration with BioPhorum.

Based on a series of experiments carried out at BTEC, BioPhorum estimates that a 50% cost reduction may be possible when switching from an open process in a grade C environment to a functionally closed system in a CNC environment. BTEC and BioPhorum recently collaborated on a three-year project to carry out studies of bioburden reduction in hybrid (stainless steel and disposable) systems in a controlled-non-classified (CNC) environment.

When announcing the project’s results, BioPhorum wrote “The study concluded that measures as simple as flushing with WFI may be successfully employed to effectively mitigate the risk of assembling and operating a modern hybrid [stainless steel and disposable] closed bioprocessing system in a controlled, non-classified environment. Over a five log reduction in bioburden was achieved with some cleaning agents.”

Beginning in 2015, BTEC conducted experiments and collected data for BioPhorum. The purpose of the study was to demonstrate that, for low bioburden processes, operating a functionally closed system in a CNC environment is equal to or better than operating an open process in a grade C environment. Closed systems offer manufacturers significant savings through the use of simpler facilities and reduced capital costs and operating expenses.

In the experiments at BTEC, a bioprocess test skid was challenged with known quantities of Bacillus subtilis and Micrococcus luteus using tri-clamp ferrule connections to simulate worst-case scenarios. Various cleansers typically found in the biopharmaceutical industry were then used to flush the skid. The residual biodurben was sampled from the process fluid and the ferrule connectors. At least a 3-log reduction of Micrococcus luteus was shown in all solutions that were tested. Log reductions for B. subtilus were between 0.4 and 4.4, with the best cleanser being 1 M NaOH, which provided 3.5-4.9 logs of reduction.

The white paper detailing the studies is available for download from BioPhorum’s website. BioPhorum has members from across the global biopharmaceutical industry and seeks to foster collaboration and accelerate the rate of progress within the industry.

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