How our expertise in both TOC analysis and cleaning validation was used to provide a client with a solution to a complex, GMP cleaning regime
The challenge
Producing life-saving antibody treatments involves a highly complex manufacturing process with numerous upstream and downstream stages. The use of diverse materials of construction in the production site results in various contact surfaces and each posing unique cleaning challenges. When transitioning between discrete antibody treatments, a robust inter-product cleaning procedure is critical to ensure the integrity of subsequent production runs.
Often, detergents contain a cocktail of chemicals to reach the quality of cleanliness required which can leave residues of organic material on surfaces. These residues, whether from production processes or cleaning fluids, risk contaminating the next production cycle. To address these challenges, the client required a reliable, quantitative, non-specific and highly sensitive technique to determine the potential contamination limits.
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