West Introduces Westar® Cartridge Components
New Ready-to-Use Components Help Maintain Drug Product Integrity
West recently introduced Westar RU (ready-to-use) components for cartridge-based injection device applications. Westar lined seals and plungers are manufactured to meet FDA and global regulatory requirements for drug packaging components and can help drug manufacturers meet increasing demand for safe, effective self-injection delivery devices. This new product line allows companies to simplify their drug development strategy, streamline manufacturing and help assure patient safety by selecting cartridge plungers and lined seals in ready-to-use format.
The Westar cartridge components product line was launched at the PDA Universe of Prefilled Syringes and Injection Devices Conference, November 5-6, 2013 in Basel, Switzerland. “The product was well received at the show,” said Tibor Hlobik, Director, Global Marketing for Prefillable Syringe Technologies, West. “There was strong interest in particular because the components do not have to be processed or sterilized before drug filling.”
Growth in both biologics and diabetes markets is driving demand for self-injection drug formats, such as pens, that ease administration and ensure patient safety. More pharmaceutical and biotechnology manufacturers are turning to injection devices with prefilled cartridge container closure systems to help patients with chronic conditions that require self-administration of therapeutics to manage their conditions at home. West cartridge components incorporate high-quality lined seals and plungers to reduce the risk of variability and the potential effects on drug quality, safety and efficacy. In addition cartridge components are available in Westar RS (ready-to-sterilize) format.
“With new challenges in administration and stricter regulatory guidelines, pharmaceutical manufacturers need to be confident that drug packaging won’t compromise drug product integrity, efficacy or patient safety,” said Hlobik. “The Westar brand is recognized worldwide for consistent high-quality components, with industry-leading particle specifications. Westar components offer superior functional performance for injectable drug delivery systems and are designed to meet the highest standards of sterility, cleanliness and purity, making sure a patient’s medication is delivered safely and effectively, every time.”
Westar RU components streamline manufacturing operations for pharmaceutical and biotechnology customers. The consistent and predictable quality of steam-sterilized Westar components ensures there will be minimal processing variation during filling and assembly, which can lead to increased throughput in fill-finish lines and less risk of line interventions. Additionally, Westar RU seals, lined seals and plungers have low bioburden, endotoxin and particulate levels and may help minimize the risk of recalls due to particulates or sterility assurance issues.
With Westar RU components, customers receive:
- Controlled particle levels in specified size ranges.
- Enhanced device functionality because of the optimized silicone level on the plungers.
- Excellent re-seal properties to meet multi-dose requirements.
- Minimized levels of potential extractables.
- The confidence that the drug cartridge components are manufactured from market-proven elastomer formulations.
Westar® is a aregistered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.