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Featured Blogs
November 10, 2022
Ensuring Sterility with West’s Ready-to-Use Offerings
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:
- FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
- EU GMP Annex 1 Manufacture of Sterile Medicinal Products
October 28, 2022
Crystal Zenith® Pre-Fillable Syringe Systems: Introducing the 2.25mL Insert Needle Barrel Assembly
Daikyo Crystal Zenith® (CZ) Pre-Fillable Syringe (PFS) systems were designed to maintain purity, integrity, and efficacy of premium biopharmaceutical therapies. The system minimizes the potential contamination issues associated with glass and helps to reduce the risk of product interactions, delays in development and scale up, and possible recalls. As an extension of the existing 1mL Long Insert Needle Barrel Assembly, West and Daikyo are proud to introduce the new 2.25mL Insert Needle (IN), providing drug manufacturers a larger volume option for the next generation of autoinjectors for at-home therapies.
November 10, 2022
Ensuring Sterility with West’s Ready-to-Use Offerings
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:
- FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
- EU GMP Annex 1 Manufacture of Sterile Medicinal Products
October 28, 2022
Crystal Zenith® Pre-Fillable Syringe Systems: Introducing the 2.25mL Insert Needle Barrel Assembly
Daikyo Crystal Zenith® (CZ) Pre-Fillable Syringe (PFS) systems were designed to maintain purity, integrity, and efficacy of premium biopharmaceutical therapies. The system minimizes the potential contamination issues associated with glass and helps to reduce the risk of product interactions, delays in development and scale up, and possible recalls. As an extension of the existing 1mL Long Insert Needle Barrel Assembly, West and Daikyo are proud to introduce the new 2.25mL Insert Needle (IN), providing drug manufacturers a larger volume option for the next generation of autoinjectors for at-home therapies.