Manufacturing Effluent Risk Modelling & Assessment System (MERMAS)

该项目将开发一个基于云的风险建模应用程序，以规范、简化和更准确、透明地计算与将制药废水排放到集水区相关的环境和抗菌素耐药性风险。药物的大规模生产和消费导致活性药物成分（API）、抗菌素和其他化合物存在于全球地表沃茨中。虽然大多数检测到的原料药主要是由于患者正常使用的原料药的消耗和排泄，但制药厂也会将含有原料药的废水排放到邻近的集水区，从而导致这一问题。随着制药业为应对新冠肺炎大流行而扩大原料药的生产，产量的迅速增加可能会在集水区形成局部的“热点，如果不加以有效管理，污水会在这些地方排放。这突出表明需要快速评估和缓解风险，最大限度地减少环境影响，并防止未来因环境中API和化学化合物增加而可能产生的不利人类健康后果，例如可能对未来全球人类健康产生可怕后果的抗菌素耐药性（AMR）增加。尽管已经存在管理制造业排放风险的自愿举措，例如AMR工业联盟和药品供应链倡议（PSCI）的抗微生物剂安全水平目标，这些倡议缺乏跨行业的标准化，并且计算缺乏有效地预测和减轻场所周围的“热点”所需的某些特定的流域背景。目前的计算考虑从生产基地排放的“安全”水平不准确地表示集水区的复杂性，包括背景患者使用的集水区，时间河流流量数据和多个生产基地排放到一个集水区的潜力。这可能导致局部API水平高于安全阈值，或错误地未通过评估。此外，在要求制造商提供安全限值的情况下，审计和计算没有标准化，最终难以验证正确性。制药公司通常有许多供应商需要审核，很难确保结果的一致性和准确性。通过这个项目，Simomics将满足制药生产基地的独特需求，开发基于云的风险预测和缓解应用程序，对暴露、影响、风险和可治疗性和重复使用等因素进行建模。与约克大学的主题专家合作，该应用程序将使环境风险评估人员和现场/合同管理团队能够更准确地了解和预测含有API的污水的环境或AMR风险，包括在集水区重新使用或释放的抗菌剂，结合背景患者使用和其他来源的污水，包括共同定位的网站。我们开发的软件解决方案将使制药商能够简化，简化，支持并提高对废水生态毒理学和AMR风险评估准确性的信心，促进位置接近的生产基地之间的合作，并使团队能够在生产变更之前，甚至在场地规划或生产合同协议之前，考虑水的浪费和可处理性，同时最大限度地减少环境和AMR风险。

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.