Manufacturing Effluent Risk Modelling & Assessment System (MERMAS)

This project will develop a cloud based risk modelling application to formalise, streamline and more accurately and transparently calculate environmental and antimicrobial resistance risks associated with discharging pharmaceutical manufacturing effluent into water catchments.

The mass production and consumption of pharmaceuticals has resulted in active pharmaceutical ingredients (APIs), antimicrobials and other chemical compounds being present in surface waters worldwide. Although the majority of APIs detected are predominantly due to the consumption and excretion of APIs from normal patient use, pharmaceutical manufacturing sites also contribute to the problem by emitting effluent, containing APIs, into neighbouring water catchments.

With pharmaceutical manufacturing scaling up production of APIs in response to the Covid-19 pandemic, rapid increases in production could create potential for localised 'hot spots' in the water catchment where effluent is released if it is not managed effectively. This has highlighted a need to assess and mitigate risks quickly, minimise environmental impact and prevent future adverse human health outcomes that could arise from increased APIs and chemical compounds in the environment, such as increased antimicrobial resistance (AMR) which could have dire consequences for future global human health.

While voluntary initiatives already exist for managing the risks of manufacturing emissions, for example the AMR Industry Alliance and Pharmaceutical Supply Chain Initiative (PSCI) safe level targets for antimicrobials, these initiatives lack standardisation across the industry and calculations lack some catchment specific context required to effectively predict and mitigate 'hot spots' around sites. Current calculations considering 'safe' levels of discharge from manufacturing sites don't accurately represent catchment complexities including background patient use in the catchment, temporal river flow data and the potential for multiple manufacturing sites discharging into one catchment. This could lead to localised API levels above the safe threshold, or falsely failed assessments. Furthermore, where safe limits are being requested of manufacturers, audits and calculations are not standardised and are ultimately hard to validate for correctness. Pharmaceutical companies often have many suppliers to audit and it is hard to ensure consistency and be confident in the accuracy of results.

With this project, Simomics will address the unique needs of Pharmaceutical manufacturing sites, developing a cloud-based risk prediction and mitigation application, modelling exposure, effects, risk and factors like treatability and re-use. Working in collaboration with subject matter experts at the University of York, this application will enable environmental risk assessors and site/contract management teams to more accurately understand and predict the environmental or AMR risk from effluent containing APIs including antimicrobials being re-used or released in a water catchment area, incorporating the context of background patient use and other sources of effluent including co-located sites.

The software solution we develop will enable pharmaceutical manufacturers to streamline, standardise, support and create more confidence in the accuracy of effluent ecotoxicology and AMR risk assessments, facilitate collaboration between closely located manufacturing sites and enable teams to consider water wastage and treatability while minimising environmental and AMR risk prior to production changes or even prior to site planning or manufacturing contract agreements.