The cleaning of production facilities makes an important contribution to drug safety: every facility must be demonstrably clean before the start of production so that no residues from the preliminary product can enter the next product. Proof of the reproducible effectiveness of a cleaning process is provided by means of cleaning validation, whereby toxicologically based limit values must be adhered to. In order to ‘play it safe’ during cleaning validation, cleaning processes are often designed generously instead of exploring the process limits as part of an optimisation process. The consequences for the environment (and the pharmaceutical company's wallet): high consumption of water and cleaning agents, high costs for water and energy, long throughput times and, last but not least, high costs for wastewater treatment and disposal.

Is there a better and more sustainable way? We want to discuss this question with Thomas Altmann. What does a ‘sustainable’ cleaning process look like? What adjustments can be made to the Sinner's circle? Does optimisation pay off from a business perspective and what needs to be considered with regard to cleaning validation?