Extractables and leachables (E&L) studies are mandatory for FDA approval. High-purity platinum-cured silicones used in medical seals exhibit extractable levels below 0.5 mg/in² after 70°C ethanol extraction for 24 hours. Such low migration prevents drug degradation in pre-filled syringes or contamination in intravenous delivery systems where seals contact sensitive biologics. https://globalsealstech.com/medical/