What Are Extractables And Leachables?

In the world of medicinal packaging, the terms extractable and leachable are especially important. An extractable is a substance or chemical that comes from a food contact surface, a medical device or its pharmaceutical packaging that No Suggestions Available along with the product being used. This contamination must be considered before the product is approved for medical usage.

A leachable is a trace amount of the processing equipment, the packaging, or the container or medical device that is left on the medicine the patient uses.

These contaminants must be proven harmless before medicine can proceed through the Food and Drug Administration approval process. Everything that goes into the preparation, packaging, and usage of a drug must be evaluated before that drug can officially be approved for use by the consumer, the patient, and/or the public at large. FDA approval means every contingency has been examined thoroughly and it passes inspection.