Microbial Aspects of Cleaning Validation: Bioburden, Endotoxins & Sterile Equipment Concerns Microbial Aspects of Cleaning Validation: Bioburden, Endotoxins & Sterile Equipment Concerns In pharmaceutical manufacturing—especially in sterile and aseptic operations—microbial contamination poses significant risks to product safety and patient health. Cleaning validation isn’t only about chemical residue removal; it must also confirm microbial cleanliness, including bioburden reduction and endotoxin elimination. Regulatory agencies like the FDA, EMA, and WHO place strict requirements on demonstrating microbial control as part of your cleaning validation lifecycle. This article provides a comprehensive guide to microbial cleaning validation, including methods for bioburden assessment, endotoxin testing, disinfectant…