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Temperature sensitive drug products, such as biologics or insulin, often require cold storage. But what, exactly is “cold”? We know it when we feel it, but often when one person is shivering, another is quite comfortable. Like humans, drug products may have specific tolerances to cold that depend upon the product.
<p>It is essential for companies in the pharmaceutical industry to be prepared to comply with compendial changes as soon as they are enacted. USP Chapter <381> (<em>Elastomeric Closure for Injections</em>), which covers West elastomeric components, is scheduled to be reissued on January 1, 2018 as <em>Components Used in Injectable Pharmaceutical Packaging/Delivery Systems</em></p>
The glass transition temperature (T<sub>g</sub>) is the temperature at which a material loses its viscoelastic properties. It is also indicative of the lowest temperature at which the polymer system will retain its functionality.
An extraction study is sometimes thought of by customers as an expensive and time-consuming exercise for filing. However, extractables studies are more than that. Performing an extraction study provides a thorough understanding of the materials used. It is a study that takes into account the primary packaging components and provides an understanding of the chemical species that may potentially come out over the shelf-life of a product.
Defined under US FDA 21 CFR 3.2 (e)(2), a <em>co-packaged combination product</em> consists of “two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products”. (1) These device products can range from delivery devices, to bandages, to antimicrobial swabs. Understanding the regulations around such a wide range of devices can be challenging; drug companies often look to the device manufacturer/provider for guidance when filing.
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