An accelerating trend in biotechnology is the use of plastic components in systems used to produce an active pharmaceutical ingredient (API) or a finished drug product (FDP).
Extraneous impurities in a drug product do not provide a therapeutic benefit to the product’s user and could adversely impact the safety and/or efficacy of the drug product. An important set of impurities
(known as elemental impurities) are those ...
Substances that leach into drug products from their associated packaging system can potentially affect the suitability of the drug product for its intended use. Thus drug products may be tested for
leachables to establish whether the leachables ...
Containers (also known as bags) are used to store final drug products, active pharmaceutical ingredients (APIs), and starting reagents and process intermediates used during the manufacturing of either the drug product itself or ingredients in that ...
Wednesday, March 19, 2014
Packaged pharmaceutical drug products can interact with their
packaging, resulting in the movement of substances from the packaging
and into the drug product. The presence of such substances in the
finished drug product is of concern due to the ...
Tuesday, January 28, 2014
Packaged pharmaceutical drug products can interact with their
packaging, resulting in the migration of substances from the
packaging and into the drug product. The presence of migratory
substances in the finished drug product is of concern due to ...
As previously published in Part 1 of this series: “Collection,
interpretation, and utilization of extractables or leachables (E&L)
data are not trivial processes and the scientific and practical
requirements for performing these activities may ...
Wednesday, March 27, 2013
During their manufacture, storage and use, pharmaceutical drug
products come into contact with polymeric materials, components
and systems. Although these components and systems are
constructed from materials and by processes that seek to minimize...