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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> (Elastomeric Closure for Injections), which covers West elastomeric components, is scheduled to be reissued on January 1, 2018 as Components Used in Injectable Pharmaceutical Packaging/Delivery Systems
The new <381> is entirely self-contained, not employing reference to other USP Chapters for specifications regarding elemental impurities. It specifies analyses for antimony (Sb), arsenic (As), cadmium (Cd), cobalt (Co), copper (Cu), lead (Pb), lithium (Li), mercury (Hg), nickel (Ni), vanadium (V), and zinc (Zn) – with quantitative reporting of actual values measured, based upon a method with detection sensitivity to 0.05 µg per gram elastomer. Anticipating these changes, West began in 2015 to develop methods to comply.
The first objective was development of methods to extract said elements from elastomeric components. The second, very challenging objective, was development of an analytical method with a sensitivity limit to such low values. After substantial research, a method was developed – employing inductively coupled plasma mass spectrometry (ICP-MS). As a resultant of these efforts, West is now properly positioned to comply with the new <381> when enacted. Moreover, West has supported USP by providing extraction methods and analytical methods that will be incorporated in the new <381>. This work is an example of not only acting to ensure patients receive the safest products, but helping to lead the industry to achieve the same goal. As always, West fully supports customers in understanding and navigating regulatory landscapes such as these.
Visit the Analytical Services section of westpharma.com to learn more about the testing West has to offer.
West strives to be the world leader in the integrated containment and delivery of injectable medicines. The achievement of this goal relies on many factors, including a heightened awareness of industry and regulatory trends. By being able to anticipate these trends, West is better able to support its customers with the knowledge and services needed to ensure that drug products reach market on schedule.
In recent years, there has been an increase in the use of multi-dose vials. First, multi-dose vials can create efficiency and reduce packaging waste when vaccines are administered to large populations. For example, both the Pfizer-BioNTech and Moderna COVID-19 vaccines provide multiple doses per vial to maximize the number of people vaccinated as quickly as possible. Secondly, multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight. This also applies to the animal health sector to accommodate the large diversity across different species, dosage differences, and use of various needle gauge sizes.
West’s Kinston, NC facility was recently recognized with an Honorable Mention at the 2016 International Society for Pharmaceutical Engineering’s (ISPE) Facility of the Year Awards’ ceremony on June 7, 2016, in Bethesda, Maryland. The award acknowledged the West team’s creativity and innovation during the Ready-to-Sterilize (RS) Expansion project, which was completed in June 2015.
One of the main risks associated with drug delivery via vial containment systems is particles that can result from fragmentation and coring of rubber stoppers subjected to needle or spike punctures. This risk can be mitigated by using prefilled syringe systems, whereby the drug dosage has been filled into the syringe by the drug manufacturer. The drug dosage is then administered by subcutaneous or intramuscular injection. A prefilled syringe system generates fewer particles during drug administration, as compared to a vial containment system. Furthermore, this form of drug delivery system ensures efficiency and greater convenience.
It is essential to consider lifecycle management during the development of new drugs – especially in the evolving area of biologic drugs. The market demand for both ease of use, and patient-centric at-home administration, is driving the need for innovative container systems and delivery devices. Typically, drugs are launched in vials; continuous development often then enables launch in other formats, such as pre-filled syringes and cartridges. West is committed to easing this movement from container systems to delivery devices through its NovaPure<sup>®</sup> component portfolio of elastomer closures. NovaPure stoppers and plungers offer best performance and highest quality. Developed with Quality-by-Design principles, they use FluroTec<sup>®</sup> barrier film and B2 coating technologies.
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