The need for PFS integrated devices
The spreading of needlestick legislation throughout the world, together with the growing concern of several organizations about the prevention of needlestick injuries have been threatening the utility of the prefilled syringe itself. Although the convenience of the prefilled, ready-to-use syringes is a matter of fact, the absence of safety-engineered needlestick protection would represent an actual problem in its usage.
Usually, syringe producers do not market prefillable syringes with inbuilt integrated needlestick protection, making the pharmaceutical companies that buy from them add secondary packaging to their injectable products, thus providing needlestick protection through clip-on accessories.
Ompi has developed an innovative, complete solution that breaks with the past, fulfilling the need for a fully-passive system that activates automatically and without any user intervention, producing an Integrated Safety System that is delivered sterile and ready for filling, preventing pharmaceutical companies from dealing with adding needlestick protection to the syringe.
Compared to traditional safety devices, the EZ-fill® ISS, as a single solution, allows less manufacturing steps, helping pharmaceutical companies to cut costs related to machineries, personnel and utilities, reducing the complexity of logistics and production process, thus increasing the competitiveness.
EZ-fill® ISS: a complete solution, from scratch to industrialization
As part of Stevanato Group, Ompi boasts the vision to drive technological innovations that combine pharmaceutical glass products and processes into high value-added systems, Ompi’s EZ-fill® ISS represents the perfect match between innovation and technology.
The project was born from a synergy of multiple forces, both at the group level and externally. Amongst Stevanato Group’s internal companies, the plastic components were produced by Balda, the assembling machine made by SVM and the EZ-fill® process optimized by Ompi, with other internal companies that acted as consultants. Tip-Top, a major designer of proprietary needlestick protection devices was the external player to provide a licensed platform for the product.
The Integrated Safety System is composed by a rubber needle shield inserted in a plastic shield with flexible wings, combined with a ring and a hub, all pre-assembled on the ISS EZ-fill® Syringe. The EZ-Fill® ISS platform is designed for 0.5ml and 1ml long staked needle syringe formats, both Fina and Nexa quality, meeting the needs of all drugs, like heparin, vaccines and the most demanding biotech.
From a user’s point of view, ISS appears to be intuitive to use and good to handle, providing automatic shield retraction and requiring a lower activation force if compared to other existing systems. Being it a fully passive system, it also prevents any risk of piercing after the removal of the rubber needle shield, making it safe and easy to use.
The advantages for Pharma companies go from the compliance with the legislation to the requiring of minimal or no disruption of the existing standard prefilled syringe production and filling infrastructure. Moreover, EZ-fill® ISS implies no modification to the universally standard container of choice and has limited regulatory impact in case of a switch.
EZ-fill® ISS has been studied since the early phases to fit the widest range of manufacturing systems and having the complete control of the technology and the process. It is able to reduce up to 36% of TCO for the PharmaCo, offering added value of the product in terms of aseptic management and safety management.
The standard Nest & Tub configuration (nest 160) in which EZ-fill® ISS comes, makes it possible to lead easy processing on existing Fill&Finish lines. This implies a simplification of the supply chain, with no need to change packaging materials, bringing a significant reduction of lead times. Thanks to one single component and to the consequent slimness of packaging, each pallet unit contains 50% more single packs, allowing to save half of transport costs.