BA Sciences has the experience to determine if any component that comes in contact with your drug product, when exposed to stressed conditions (extractables), or from regular use over time (leachables), will have a negative impact on your product. Additionally, if you are a manufacturer, BA Sciences will determine conformance for single use systems and other manufacturing components. This is a crucial step of the filing of drug products with the FDA, and the results of this testing also can provide useful insights into how compounds may affect human health. With over 30 years of combined experience, our team is ready to assist you in your extractable and leachable needs.
Extractables and Leachables
