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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
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Because the isomerisation product is mass-identical to the parent, elapsed time in solution is the only practical proxy for degradation available without a dedicated method
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