CHEMICALS & PHARMACEUTICALS
FIGHTING BACK AGAINST ANTIMICROBIAL RESISTANCE
Barry O’Neill, EHS Manager at Gaelic Laboratories, explains the role of pharma manufacturers in minimising the spread of antimicrobial resistance, and offers insights into achieving compliance with the AMR Industry Alliance Manufacturing Standard
T
he emergence of antimicrobial resistance (AMR) across the world is recognised as a significant global health challenge. AMR develops when colonies of microbes like bacteria change in ways that make antibiotics less effective. In recent decades, these changes have been accelerated by human activity, such as the misuse and overuse of antibiotics. In addition, it has become clear that emissions of antibiotics from manufacturing sites can contribute to new forms of AMR. This recognition led to the concept of AMR Stewardship in antibiotic manufacturing. Pharmaceutical manufacturers have an important
role in controlling AMR, as recognised by the formation of the AMR Industry Alliance nearly a decade ago. The international coalition encourages responsible antibiotic manufacturing, enacted through a Manufacturing Standard that was updated with the latest scientific evidence in 2025. It is broadly accepted that the AMR Industry Alliance Manufacturing Standard provides the benchmark for responsible antibiotic manufacturing. It places a focus on waste management and API discharge limits. Organisations aiming to demonstrate adherence to this Standard pursue the BSI Kitemark for Minimized Risk of AMR. Compliance involves a combination of operational controls, environmental risk management, governance improvements, monitoring activities, procedural strengthening, and cross-functional engagement across manufacturing, engineering, quality, environmental health and safety, and laboratory operations (Figure 1).
Wastewater management Concentrations of antibiotics in industrial effluents are considerably higher than those found in sewage, so AMR stewardship places a strong emphasis on wastewater management. An optimal approach is to perform routine testing by an in-house expert lab team, complemented by additional independent testing at an external local treatment platform. Such dual testing approaches ensure that any accidental leakages would be quickly detected and dealt with. Wastewater monitoring involves the collection,
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Figure 1. Schematic overview of antibiotic
manufacturing, highlighting potential losses to water and waste, and the steps taken to avoid accidental release of APIs or drug products
analysis and management of wastewater discharged from manufacturing facilities by assessing composition, determining contaminants, and implementing measures to avoid the release of polluted water. Antibiotic residues need to be quantified to make sure they fall below the Predicted No-Effect Concentration (PNEC) for a particular antibiotic [1]. An extensive list of PNECs for available antibiotics has been scientifically calculated and is updated annually; for any new products for which a PNEC is not yet available, a default limit of 0.05 µg/L applies. Equipment upgrades might be required at many sites for environmental controls, monitoring
PROCESS & CONTROL ENGINEERING | JULY/AUGUST 2026
capability, containment practices, wastewater-related controls, and supporting systems and processes. Fortunately, before embarking on this exercise, Gaelic Laboratories had obtained a new monitoring station for effluent wastewater, as well as an upgraded extraction system that controls API air particulates. The entire site was also utility-mapped after being acquired in 2022, because the previous owners had no record of drain locations.
Solid waste
Solid waste potentially containing active ingredients must be gathered and stored in a manner that prevents discharge. Once it leaves the site, the
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