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
Known for a commitment to excellence in elastomeric components, West has complemented its vial closure portfolio with the Flip-Off® seal brand. Particularly in its ability to provide solutions for aseptic and clean crimping, the Flip-Off seal demonstrates potential to become an industry standard.
The highest quality offering is the Flip-Off® CCS seal. It is used for aseptic crimping and its name reflects the key product attributes: Clean, Certified and Sterilized (CCS). Customers crimping in an aseptic area are looking for a low specified particle level (in line with grade A classification and comparable to ISO 5 guidelines)1,2 and a pre-specified bioburden prior to sterilization. These features, combined with an optimal seal manufacturing process, give pharmaceutical manufacturers the option of smooth, clean operation within an isolator.
Flip-Off® Plus is the newest member in the Flip-Off seal portfolio and is designed to meet the needs for clean crimping outside of the aseptic core under Grade A, but under constant Grade A air supply (laminar flow)². Although less stringent regulations apply for the clean crimping process compared to crimping in an aseptic area, the Annex 1 of EMA regulations require a specified bioburden for sealing². Flip-Off Plus was launched to support fill-finish operations to comply with the needs for bioburden speciation and offer a high-quality, easy to use component for drugs marketed within the EMA jurisdiction and beyond.
For pharmaceutical customers, West delivers consistency and reliability. The same high-quality standards are applied to all sterilized seals and elastomeric components. These offerings are ready to be processed immediately and guaranteed to meet tight component quality levels, which may reduce complexity in an already highly complex pharmaceutical manufacturing environment. Additionally, relying on West products and services can potentially reduce downtime and simplify inventory management.
Click here to learn more about the Flip-Off seal brand.
West’s Waterford, Ireland site recently partnered with CALMAST which is Waterford Institute of Technology’s (WIT) STEM (Science, Technology, Engineering and Math) engagement hub that was established in 2003 to drive more awareness of STEM, building on the work of secondary schools in the south east region of Ireland.
West Analytical Services, LLC continues to invest in the expertise and technology needed to support and partner with customers. This is essential to enable customers to pair new and more complex drug products with the right containment systems, delivery systems and combination products – and navigate the challenging, and ever-changing, regulatory environments. Expansion of the capabilities is focused in four critical areas: (1) extractables and leachables (E&L); (2) container closure integrity (CCI); (3) particle analysis; and (4) testing for packaging, devices and combination products.
Earlier this year, we held a free 3-day virtual workshop (4 hours per day) bringing together industry experts and thought leaders in a unique forum to address a series of challenges and practical strategies to de-risk their injectable combination product development and commercialization.
Critical quality attributes (CQAs) of biologic drug products can be affected by multiple factors throughout the product lifecycle, including the container closure and delivery systems. Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, discussed containment and delivery system compatibility with biologic drug products along with regulatory considerations in her presentation Establishing Safety of Container Closure and Delivery Device Systems at the PepTalk 2017 conference. Evaluating potential impacts early, holistically, and throughout bioprocessing can facilitate decisions at each step that will minimize risks to CQAs and safety.
West’s subject matter experts are out and about this spring with speaking engagements and booths booked at a variety of conferences and trade shows.
English
Chinese
