The assessment of substances that can be extracted (extractables) or leached (leachables)
from the materials that come in contact with pharmaceutical products often starts with a …

The analysis of reference standards may be performed to enhance the qualitative and
quantitative data generated by non-specific screening methods utilized in extractables …

Important safety aspects of compatibility for therapeutic products and their manufacturing
systems, delivery devices, and containers Compatibility of Pharmaceutical Products and …

Demonstrating suitability for intended use is necessary to register packaging,
delivery/administration, or manufacturing systems for pharmaceutical products. During their …

In recent years, the pharmaceutical industry has been adversely affected by an upsurge in
the recall instances of pharmaceutical products. This is due to the leaching of the chemical …

During the course of their manufacturing, storage, and administration, pharmaceutical drug
products come in contact with materials, components, and systems. Such contact may result …

Several scientific, quality control, and regulatory approaches are used to control and assess
the risk of foreign substances that are inadvertently added to products that humans …

The quality of state-of-the-art materials has improved considerably during the past 25 years.
However, it is known that all processing systems can release insoluble or soluble materials …

The assessment of all materials-and especially elastomeric and plastic components-for the
presence of leachable and extractable components, forms an important part of the …

Quantitative information on process equipment-related leachables (PERLs) is required for
process qualification and within a safety assessment. Extractables data for single-use …