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Gowder SJT

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Theurey et al., 2016

That means: ISO-7 cleanroom environments with continuous air quality monitoring and particle counts that meet sterile compounding specifications ISO-5 laminar airflow hoods at every point of direct compounding contact Endotoxin and sterility testing on finished lots not just environmental monitoring, but direct verification of the product going out the door Beyond-use date validation specific to the formulation, not borrowed from reference tables Ingredients from FDA-registered suppliers exclusively the quality chain starts at sourcing, not compounding On top of that framework, MediVera invests $60,000+ monthly in third-party testing independent potency and sterility verification that sits outside our internal QA process