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The right seal is essential for proper drug product vial closure. West offers a wide range of Flip-Off® seal (FOS) products to meet customers’ varying requirements. Three grades are available for crimping needs in varying environments:
Flip-Off® Plus and Flip-Off® CCS seals are certified for pre-sterilization bioburden, as required by EMA GMP Manufacture of Sterile Medicinal Products - Annex 1. In addition, the rigorous control of cleanliness in manufacturing of Flip-Off® CCS seals enables a visible particle specification (since it is not recommended to wash aluminum shells). These three offerings are further branched into gamma-sterilized or ready-for-steam-sterilization (RS) options:
* RUI: ready-to-use irradiated
West Spectra™ seal technology is West’s proprietary method for messaging needs on Flip-Off® seals – to provide point-of-use instructions, product authentication and counterfeiting deterrence. It comprises printing and in-mold text on the plastic button, and/or printing on the aluminum shell. Note that all drug products offered in the US must meet the requirement in USP General Chapter <1> Injections regarding labeling.
At West, patient safety is the highest priority. The wide range of seal products and messaging technology enable this. For more information, please contact the West Technical Customer Support team, who can help to recommend the right FOS product.
West’s Flip-Off seal color configurator offers a unique online option to create a colorful combination for drug products. Try it here.
Protein-based therapeutics are examples of the advancement of modern medicine and a revolution in drug discovery. Monoclonal antibodies (mAbs) account for the majority of biologic FDA approvals, and due to their low bioavailability by oral delivery means, they necessitate a shift to parenteral delivery. Hence, mAbs are typically packaged and stored in liquid or lyophilized format in glass vials, prefilled syringes, or cartridges for later injection.<br />
<p>West is committed to partnering with and providing analytical and technical support for customers so that they can successfully develop drug products and deliver them to patients.</p>
Do you want to better understand how to navigate the regulatory pathway to successfully bring a drug/device combination product (CP) to market? Understanding that many have this question, West, in collaboration with the Delaware Valley Chapter of PDA, sponsored the symposium (Sep 23): <em>The Evolving Landscape for Combination Products – Defining a Regulatory Strategy</em>. Experts from the industry and the FDA presented and discussed the latest best practices.
Ensuring the sterility of sterile medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on the patients, as well as the potential for costly product recalls. The importance of control strategies to ensure sterile drug products has also been reiterated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines: <br /><ul><li>FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
<p><span style="background: white;">In our latest Team Member Spotlight, read about the learning and development opportunities available at West and how Karol progressed from his starting position as a production operator to his current role as Senior Automation Engineer at our Dublin facility in Ireland.</span></p>
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