A thorough evaluation and standardisation of the use of environmental isolates (EIs) in AstraZeneca's microbiology laboratories was performed. The study was prompted by the increasing use of EIs in pharmaceutical microbiology laboratories over the past two decades and aimed to ensure robust methods for recovering all types of microorganisms that may pose a risk to the quality of medicines. The cost, time and robustness of the testing performed with environmental isolates was identified as an area for continuous improvement by internal audit of site procedures. The review identified a wide variety of interpretations of where and what to include for EIs in growth promotion tests, methods, and disinfection efficacy studies across AstraZeneca's microbiology laboratories, leading to potential overuse. The study involved a global cross-site review that utilized a risk assessment process, involving 10 expert pharmaceutical microbiologists with significant industry experience and a risk management subject matter expert. The review assessed various uses of environmental isolates, such as growth promotion testing, disinfectant qualification studies, and method suitability testing, with a focus on regulatory requirements, external audit commitments, and scientific rationale. Regulatory guidance for the use of environmental isolates was reviewed, and a requirement for their use was noted in specific documents, such as the EU Guidelines for Good Manufacturing Practice for Medicinal Products² and various USP chapters. The literature review provided external viewpoints and aligned with the approach within AstraZeneca, confirming the need for a risk assessment in the use of isolates. The paper concludes by outlining the scientific rationale for the use of environmental isolates and provides guidance on when and how to select the most appropriate EIs for different test types. The study resulted in the production of a global guidance guideline, allowing sites to implement a standard approach to the use of EIs, leading to a significant reduction in their overuse and a standardisation across the business. The conclusion emphasises the importance of utilising environmental isolates where they add the most value or where they are required by regulations. This paper provides valuable insights into the evaluation and standardisation of the approach to using environmental isolates in AstraZeneca's microbiology laboratories, offering a foundation for a global standard and a reduction in their overuse.
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