We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Every day, all day, safety matters. Safety never takes a day off. All around us we see safety warnings such as allergens on food labels, use-by-dates on milk and expiration dates on medications. There is no substitute for doing things safely. For pharmaceutical and biotechnology companies offering parenteral drug products, patient safety is the utmost concern.
To be approved in the US, a new drug product must pass three hurdles established by the FDA. Sufficient evidence is required to demonstrate:
Selecting the right packaging/delivery system is essential to satisfying these requirements. If the packaging/delivery system fails, patient safety is lost. West partners with drug product producers to help select the right packaging/delivery system:
With the trend that more drug products are self–administered, as compared to a clinical setting, selection of the right packaging/delivery system is even more crucial. With drug product producers, West not only shares in the concern, but has the ability to help achieve that utmost objective – patient safety. For more, contact a West account manager or TCS representative.
At some point early in the development of a drug product, pharmaceutical manufacturers must make a very important choice. How will the final product be delivered to the patient? That choice leads to a variety of additional choices regarding drug formulations, stability, container closure systems and the various interactions of the drug with its packaging, and ultimately, patient compliance.
The FDA states: <em>Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* </em>While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
<p>West is committed to partnering with and providing analytical and technical support for customers so that they can successfully develop drug products and deliver them to patients.</p>
Where is the product catalog? What is my item number? These questions are often asked by customers new to working with West. The problem with such questions when it comes to choosing primary drug packaging is both complex and simple: <em>people don’t choose the container closure system – rather, the choice is made by the properties of the drug product. In other words, the drug <span> </span>chooses the container.</em>
English
Chinese
