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
In 2015, the FDA shed light on a problematic practice within the healthcare industry involving improper, off-label use of syringes as closed container storage systems for compounded or repackaged drugs. The incidents cited revealed that interaction with rubber plungers in syringes that were not cleared for the purpose of closed container storage resulted in the loss of potency of several drugs when administration was delayed.1
So how are these compounded syringes any different from FDA-approved pre-filled syringes on the market today? The difference is in the lack of proper evaluation by compounding pharmacies of the syringe systems for intended use/storage that the FDA requires for approval of pre-filled syringes. With subpotent drugs and further adverse consequences an all-too-real risk to patient safety, compounding pharmacies need to consider the risks of their packaging choices. Given the changing regulations affecting compounding pharmacies, it is no longer safe to assume past practices and previous component selections will continue to meet FDA requirements.
To mitigate risk and ensure future compliance with the changing regulations, the following packaging considerations should be addressed:
West can help achieve compliance by offering:
West is committed to the safe and efficient delivery of drug products. An element of this commitment is staying abreast of regulations and offering customers the information and testing services they need through the Integrated Solutions platform. For more information, contact an Account Manager or Technical Customer Support (TCS) representative.
Recently, our Dublin, Ireland facility won the 2017 “Green Pharmaceutical Award” – a long-standing benchmark of excellence for those demonstrating best green practices in Ireland. Winners were announced at the Green Awards ceremony on February 21, 2017.
<p><em>A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry</em></p><p><em>The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization</em></p>
West’s Tibor Hlobik and Chris Evans will present at the 2015 Drug Delivery Partnership conference, January 28-30 in Boca Raton, FL.
The pharmaceutical supply chain is more complex than ever, with the pricing of critical drugs a subject for hot debate in the media and, most recently, in U.S. Congressional hearings.
<em>Welcome to Tech Talk, our latest feature from blogger Beverly Prohaska, Vice President, Global Information Systems. These features will discuss how West uses information technology internally and externally to help ensure customer satisfaction. Look for Tech Talk to appear regularly on the West blog.</em>
English
Chinese
