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Pharmaceutical and healthcare companies around the world rely on the expertise of West's contract manufacturing team—formerly known as The Tech Group to create innovative, safe and effective drug delivery systems that bring important therapies to patients. For those companies – like ours – quality and innovation are of the utmost importance.
In part one of our video series West on the Road – Tempe, we look at how West's contract manufacturing Rockford campus in Tempe, Arizona is developing advanced automation systems and programs to ensure the quality and efficacy of drug delivery and monitoring systems. This begins by establishing manufacturing processes based on a deep understanding of the customer’s needs and the products themselves. West's contract manufacturing engineers at the 96,500-square-foot facility learn our customer’s products inside and out. They combine that insight with their deep knowledge of medical devices and materials, such as plastics, as well as the latest in insert and multi-shot molding techniques to ensure we’re meeting the needs of our pharmaceutical partners and the patients relying on them.
While the medical manufacturing industry today may be complex as ever, Director of Operations, Mike Moran, believes that manufacturing processes will only grow in complexity in the coming years as a changing healthcare environment—one that is ever more patient-centric—will continue to demand more of the pharmaceutical industry and their manufacturing partners.
Ultimately, people at the contract manufacturing plant understand the critical role that they play in bringing drug delivery systems from concept to patient and delivering the high quality that our pharmaceutical customers – and patients – demand.
<p>The needle of a pre-filled syringe is extremely important. From manufacture, through packaging/transportation, to patient delivery – if the needle is not protected, the drug product cannot be delivered effectively. To protect needles to ensure patient safety, West has developed <a href="/products/prefillable-systems/syringe-components/rigid-needle-shields-and-tip-caps">Rigid Needle Shields </a>(RNS) in two sizes: 1/2” for subcutaneous injections (e.g., heparins) and 5/8” for intramuscular injections (e.g., vaccines). RNS consist of a two-part system – a soft rubber inner shell and a perforated, hard polypropylene outer shell. This system maintains container closure integrity (CCI) for both an ISO 11040 glass syringe with staked needle, and a polymer-based syringe (e.g., <a href="/products/prefillable-systems/daikyo-syringe-systems/insert-needle-syringe-components">Daikyo Crystal Zenith® insert needle syringe</a>).</p>
Diane Paskiet, Director, Scientific Affairs, serves as co-chair for the 2014 PDA Packaging Conference: Pharmaceutical Packaging Systems – <em>Current and Emerging Practices, Technologies and Materials</em>, which will be held at the Washington Marriott Wardman Park, Washington, D.C. on May 20-21, 2014.
The FDA’s Center for Devices and Radiological Health (CDRH) released four final guidance documents on Thursday, Sept. 12, which provides the FDA’s current thinking on the Special 510(K) program, the Abbreviated 510(K) program, how to format Traditional and Abbreviated 510(K)s and the new Refuse to Accept policy for 510(K).
Today’s regulatory guidelines and requirements for pharmaceutical manufacturers are getting more specific and stringent, ensuring that drug products are safe and that there is no compromise with the possible use of unsuitable and/or non-compliant packaging components. For instance, regulatory guidelines require use of clean components (inclusive of secondary seals for this context) for sterile filling operations.