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Gerresheimer, a system and solution provider and a global partner for the pharma, biotech, and cosmetic industries, has unveiled Gx Elite vials, designed to maximize patient safety and production efficiency through a quality by design approach.
The main advantages of the product are its superior quality, which is reflected, for example, in its high breakage resistance and production efficiency. The advanced primary packaging solution is particularly suitable for sophisticated drugs such as biopharmaceuticals and innovative vaccines. Gx Elite vials can be delivered in bulk or pre-sterilized ready-to-fill in Gerresheimer’s innovative EZ-fill Smart packaging.
“The trend toward sophisticated and innovative drugs such as biopharmaceuticals and innovative vaccines, is placing new demands on the quality and performance of primary packing solutions,” says Holger Krenz, Global Vice President Business Development High Value Products Tubular Glass at Gerresheimer. “At the same time, these new solutions are changing the working relationship between the pharmaceutical industry and packaging manufacturers.”
Up to four times more break-resistant and ready for cold storage
Gx Elite vials stand for highest quality, enabling them to reliably protect valuable drugs during the entire lifecycle. Each year, the Elite-qualified Gerresheimer manufacturing facilities undergo a round-robin test to verify specifications. Furthermore, Gx Elite vials maintain Container Closure Integrity (CCI) during cold storage at -80°C, proven by testing with Lighthouse Instruments LLC. The Gx Elite vials are the result of years of product development using quality by design principles and are manufactured using a patented process that also eliminates micro-defects of 100 microns or greater.
EZ-fill Smart packaging
Gx Elite vials are also available in the new, optimized EZ-fill Smart packaging. The innovative RTF packaging platform simplifies the filling process, lowers costs and reduces the particle load by more than 90% by replacing the Tyvek lid with a polymer sealing film. This means that no Tyvek fibers or adhesive particles are released when the film is peeled off just prior to the filling process. This greatly reduces the risk of particle contamination.
Sustainable Vapor Hydrogen Peroxide Sterilization
The cutting-edge Vapor Hydrogen Peroxide (VHP) sterilization offers an eco-friendly solution for maintaining the highest standards of product and workplace safety. This sustainable method efficiently eliminates contaminants without leaving harmful residues, reducing energy consumption and waste. Ideal for pharmaceutical and healthcare environments, Gerresheimer has implemented the VHP sterilization technology that fully complies with the latest FDA requirements and recommendations and supports the company’s sustainability targets.
Extensive portfolio of ready-to-fill products
Gx Elite vials are part of Gerresheimer’s extensive ready-to-fill portfolio. Ready-to-fill products, also known as ready-to-use or RTU products, allow the pharma industry to focus on its core competencies and save the costs and time required for washing and sterilizing primary packaging. As a result, drugs can be brought to market faster and with lower overall costs in the manufacturing process.
