Table of Contents
What is a leachable substance?
A leachable substance is a compound that can migrate or leach into a drug product formulation over time from the packaging or device component or through contact with a production material as a result of direct contact with the drug formulation.
What does leachable mean?
Leachables are compounds that leach into the drug or biological product from the container-closure system such as the elastomeric or plastic components, or coatings of the container and closure system.
What is the difference between extractable and leachable?
Extractable studies can also be used as a baseline to ensure SUS consistency over time. Leachable studies determine the chemical compounds that migrate from SUS into process solutions and characterize possible adsorption and/or absorption of process fluid (under normal process conditions).
What is leachable data?
Leachables are chemical species that make their way into the product under normal product, application or storage conditions. There is generally an overlap such that the leachables involved may be classified as a subset of the extractables.
What is leachable test?
Extractables and Leachables Testing is an analysis of potentially harmful materials that could be administered to a patient with a drug or device. Pharmaceutical manufacturers use laboratories to assess whether chemicals are transferring into the drug from packaging or production.
What is leachable and extractable test?
What is E and L testing?
Extractables and leachables (E&L) testing is an FDA required step in filings of drug products or devices to determine what effect the packaging, delivery system, device materials or any other component that interacts with the drug or patient will have on it.
What are the possible sources of leachable materials?
•Packaging operations •Intermediate storage •Final storage I. Markovic PQRI meeting Feb 2011 28 © Smithers Rapra 2015 Possible sources of leachables •In-Process/single use systems •Bioreactors, containers and storage bags for product intermediates, IV bags, filters, tubing, gaskets, valves, rings etc •Stainless steel storage tanks/bioreactors
What is a leachable?
Chemical species that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product formulation under normal conditions of use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables.
What are leachables and extractables in polymers?
Leachables and extractables are the tiny molecules that are present in a polymer system including surfactants, antioxidants, plasticizers, slip agents, acid scavengers, lubricants, crosslinking agents, residual monomers and oligomers.
How to determine the profile of leachables in a product?
It should be determined whether any of the extractables are also leachables present in the formulation at the end of the shelf life of the product or to the point equilibrium is reached, if sooner. The leachables profile should also be determined for compendial plastics and rubber container closure components.