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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:
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.
In recent years, there has been an increase in the use of multi-dose vials. First, multi-dose vials can create efficiency and reduce packaging waste when vaccines are administered to large populations. For example, both the Pfizer-BioNTech and Moderna COVID-19 vaccines provide multiple doses per vial to maximize the number of people vaccinated as quickly as possible. Secondly, multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight. This also applies to the animal health sector to accommodate the large diversity across different species, dosage differences, and use of various needle gauge sizes.
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