Extractables and leachables in drugs and packaging?

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Jody Hickle asked a question: Extractables and leachables in drugs and packaging?
Asked By: Jody Hickle
Date created: Wed, Dec 30, 2020 8:26 PM
Date updated: Fri, Dec 9, 2022 4:17 PM

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Video answer: Packaging components: extractable/leachable control

Packaging components: extractable/leachable control

Top best answers to the question «Extractables and leachables in drugs and packaging»

Typical extractables include surfactants, plasticizers, antioxidants, dyes, heavy metals, and curing agents. Leachables are compounds that migrate from packaging materials into drug products under normal storage, handling, and use conditions over the lifetime of the drug product.

Video answer: Necessity of extractable & leachable qualification for lyophilized drug products:fallacies addressed

Necessity of extractable & leachable qualification for lyophilized drug products:fallacies addressed

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In an effort to provide clarity with respect to extractables and leachables used in primary packaging and the manufacture of drug products, USP introduced a series of chapters specifying the approach to characterize and qualify both packaging and manufacturing systems with respect to patient safety.

The potential for harmful chemicals to be extracted from packaging materials that pose a risk to patients has spurred regulatory authorities to establish guidelines for extractable and leachable (E&L) testing for primary drug packaging materials. 1–3 Drug licence holders must establish programmes that effectively assess and test these contamination risks. In 1999, following the introduction of the asthma drug salmeterol in the UK, three cases of respiratory arrest occurred shortly after ...

system, packaging component, or packaging material of construction under laboratory conditions including extraction solvent, technique, stoichiometry, temperature and duration. Extractables themselves, and/or substances derived from extractables, have the potential to leach into a drug product formulation under normal conditions of storage and use.

The FDA recommends drug manufacturers perform extractables analysis as part of the qualification for new container and closure systems. Corresponding leachables analysis of drug products is part of the Suitability for Use criteria considered standard by the bio/pharma industry today and expected by global regulatory authorities.

Best practice recommendations and compendial standards for extractables and leachables note that a leachables-extractables correlation (either qualitative or quantitative) should be established by linking actual drug product leachables with extractables from corresponding controlled extraction studies performed on either the packaging system itself, individual components, or individual materials of construction.

Leachables are compounds that migrate from packaging materials into drug products under normal storage, handling, and use conditions over the lifetime of the drug product. All packaging components – and components of medical devices – have the potential to act as sources of extractables and leachables.

Extractable and leachable impurities from pharmaceutical container-closure and production systems. In May 1999, the U.S. FDA published a guidance document on Container Closure Systems for Packaging Human Drugs and Biologics. The FDA mandated that pharmaceutical manufacturers demonstrate the safety of materials used in production systems, container ...

Extractables are compounds that can be extracted from a packaging component, delivery system, or manufacturing surfaces via laboratory manipulation, such as exposure to solvents or heat. Extractables can be potential leachables. Leachables are compounds that passively migrate into the drug product over time, as a result of direct contact from the packaging system, in-use componentry, or a manufacturing surface. 2. What types of e&l studies does Alcami support?

conditions of storage and use and become leachables. Thus extractables are potential leachables. Leachables are foreign organic and inorganic chemical entities that are present in a packaged drug product because they have leached into the packaged drug product from a packaging/delivery system, packaging component, or packaging material of

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Video answer: How mass spec identifies extractables and leachables from consumer packaging | behind the science

How mass spec identifies extractables and leachables from consumer packaging | behind the science