Datwyler, a leading manufacturer of elastomer components for pharmaceutical packaging, is expanding its portfolio with two new products to meet evolving patient demands. The new offerings include a 5/8 in. rigid needle shield (RNS) to address the rising need for prefilled syringes to contain vaccines for intramuscular injection, and isoprene rubber discs for infusion therapies.
Datwyler’s new 5/8 in. RNS answers the call for solutions to increasingly urgent challenges posed by the ongoing pandemic. The onset of COVID-19 has accelerated growth in demand for prefilled syringes and correlating needle shields. The prefilled syringes market is now expected to grow around 13% in the period 2021-2025 reaching a volume of 7.5 bn units provided at global level at the end of 2025. During the same period, the 5/8 in. RNS market is expected to grow around 25%, reaching a volume of 1.75 bn units provided at global level at the end of 2025.
“There is an expansion of global and regional immunization programs addressing viruses like COVID-19 as well as the seasonal flu and other pediatric vaccine requirements. Simultaneously, mounting safety concerns around the risk of needle stick injuries among healthcare providers are driving higher safety standards and as a result, greater interest in no-pierce, rigid plastic caps over plain rubber shields,” said Carina van Eester, global product leader at Datwyler for prefilled syringes and cartridges. Especially in applications that require nurses and doctors to perform many vaccinations in a short amount of time, an RNS offers more comfortable syringe handling and reduces the risk of needle sticks.
Datwyler’s 5/8 in. RNS is designed with a best-in-class rubber formulation known as FM30. FM30 enables worldwide regulatory compliance with a low extractable profile and an adequate gas permeability that allows ETO sterilization and facilitates controlled pull-off force, high separation force and excellent seal integrity. The design is also compatible with standard PFS and runs on standard syringe assembly lines with no necessary changes.
Additionally, Datwyler’s introduction of isoprene rubber discs will also help meet the demand for the packaging of a wide range of infusion therapies. “This product is an excellent addition to Datwyler’s parenteral packaging portfolio,” said Howie Yang, market lead for Datwyler in China. In countries throughout Europe, the Middle East, and Asia where infusion therapies continue to be packaged in rigid plastic containers, infusion discs are highly necessary components for treatments of chronic illnesses, infectious diseases, dehydration, post-surgery treatments, and the administration of antibiotics.
Available in a wide range of sizes and configurations, Datwyler’s infusion discs are manufactured at the company’s Advanced production level and in dimensions that align with ISO 15759 as well as in other customized designs out of its newly acquired facility in Shandong, China – Yantai Xinhui Packing. The range of discs offer excellent functional properties compared to market alternatives including exceptional penetration force, resistance to fragmentation, and resealability. The discs rubber formulation also complies with international compendial requirements. The addition of infusion discs completes Datwyler’s product portfolio for IV system components, which also includes injection sites, sleeve stoppers and vascular seals for peripheral venous catheters.
