The FDA defined Leachable’s as “Organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drug products under conditions of normal use.”

Leachable species may be found in a variety of sources such as:

• Manufacturing (Filters, Single-use bags, Tubing…)
• Primary packaging — External components (Container-closure system (vials, caps, lids and foils), Single-use systems (syringes and intravenous bags))
• Primary packaging — Internal components (Gaskets and O-rings, Valves, Springs)
• Secondary and tertiary packaging (Labels and adhesives, Inks and colourings)

Leachables from the production and packaging processes that enter pharmaceutical items must be tracked and detected. Patient safety is ensured by the compiled data, which enables a toxicological evaluation of any leachables discovered.

Our laboratory begins by learning everything there is to know about your packaging & manufacturing system in order to provide a thorough picture of all potential sources of leachables. Our team can anticipate and identify possible sources of risk linked with leachable impurities through strategic screening tests thanks to our experience in method development for a controlled extractables research and our extensive understanding of leachable substances and regulations.

Medistri’s Laboratory provides GMP-compliant leachables method validation for use in GMP stability testing and storage programs and are able to support a variety of closure or drug delivery systems — including:

• Pre-filled Syringes.
• Pharmaceutical Vials.
• Large Volume Parenteral Products.
• Orally inhaled and nasal drug products (OINDP).
• Single-use and disposable medical equipment.
• Printed packaging.
• Secondary packaging migration behaviour.
• Medical Devices (ISO 10993–18).
• Drug Deliver Systems.