Scribd Logo
Upload

Welcome to Scribd!

  • 70 views

    NovaPure Information Sheet

    Uploaded by

    Satish Hiremath

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    NovaPure Information Sheet

    Uploaded by

    Satish Hiremath
    70 views2 pages

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    70 views2 pages

    NovaPure Information Sheet

    Uploaded by

    Satish Hiremath

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    NovaPure® Components for Vials

    It’s all too common. Full lots of injectable drug products are rejected or even recalled due to visible particulate
    in solution. Increasing awareness of the risks associated with particulate contamination has pharmaceutical
    manufacturers seeking cleaner, more consistent packaging components.

    PACKAGING CAN BE A RISKY BUSINESS


    Contamination and particulate attributed to elastomer components and packaging can be
    a source of risk and variability, putting the quality of your drug product and the ultimate
    safety of your patients at risk. Sensitive pharmaceuticals and biopharmaceuticals
    demand high-quality packaging to maintain drug purity and efficacy.

    REJECTIONS & RECALLS CAN BE COSTLY


    Product rejections impact the bottom line through increased costs,
    lost batches and manufacturing inefficiencies. Product recalls can
    have a negative impact on patient confidence, market share and
    shareholder value.

    NO BARRIER IS UNBREACHABLE FOR A LEACHABLE


    While technologies such as barrier films may reduce leaching, they do not
    negate the need for comprehensive extractable/leachable studies. Careful
    elastomer component selection should be coupled with an understanding of
    key extractables in order to anticipate leachables over time.

    REGULATORY SCRUTINY HAS INCREASED


    Global regulatory concern over particulate and resulting actions are
    evident throughout the industry. Recent research* has shown that 22%
    of injectable recalls between 2008-2012 were attributable to particle-
    related issues.

    QUALITY PACKAGING BEGINS BY DESIGN


    Selecting packaging components manufactured under the principles of Quality by
    Design can offer exceptional cleanliness and the tightest limits on particulates.

    QbD Additionally, such components offer reduced risk of variability, product loss and
    minimized total cost of ownership. When you choose the highest quality elastomer
    components, you help ensure your ultimate goal – patient safety.

    Talk to your West representative and choose the right option for your product,
    and ultimately, for your patients’ health.
    *Lynn S. Drug Defects. Presented at the 37th International Good Manufacturing Practices Conference, March 14, 2013, Athens, Ga.
    Mitigate Risk with Quality by Design
    NovaPure® Components for Vials
    Unrivaled Quality...By Design

    Components manufactured with Quality by Design principles meet Critical Quality Attributes:
    • Sub-visible particle specifications
    • Tight visible particle specifications
    • Minimized exposure to sources of cellulose
    • Critical dimensions measured in CpK

    NovaPure components for vials help you:


    • Reduce quality issues associated with particulate
    • Protect sensitive drug products with exceptional cleanliness and barrier properties
    • Address patient needs with an in-depth Quality Target Product Profile (QTPP)
    • Minimize Total Cost of Ownership

    West offers enhanced transparency to NovaPure Customers via:


    • 24/7 access to Customer Connection, a comprehensive online library of process and product documents
    • Key extractable reporting to monitor material consistency and minimize variability of leachables
    • Regulatory support, including a Drug Master File in Common Technical Dossier (CTD) format for
    US & Canada

    Configuration Quality Treatments

    13mm serum stopper FluroTec® Barrier Film


    B2 Lubricity Coating
    20mm serum stopper
    Westar® RS Wash & RU
    13mm lyo stopper Sterilization Processes
    Envision™ 100% Auto
    20mm lyo stopper Verification

    Visit West today at www.westpharma.com today to learn more.

    West Pharmaceutical Services, Inc. I 530 Herman O. West Drive, Exton, PA 19341

    West and the diamond logo, Westar®, FluroTec® and Envision™ are trademarks or registered trademarks of
    West Pharmaceutical Services, Inc. in the United States and other jurisdictions. FluroTec® technology is licensed from Daikyo Seiko, Ltd.
    For complete contact information please visit www.westpharma.com.
    Copyright © 2016 West Pharmaceutical Services, Inc. #10327 0916

    You might also like

    pFad - Phonifier reborn

    Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

    Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


    Alternative Proxies:

    Alternative Proxy

    pFad Proxy

    pFad v3 Proxy

    pFad v4 Proxy