The pharmaceutical sector is built on a philosophy of progress. The constants of innovation, research and experimentation sustain a steady stream of scientific and technological discoveries aimed at improving processes, products and patients’ lives.
Progress, however, rarely results in things getting simpler. For pharmaceutical companies, each step forward can give rise to new challenges, whether they are concerned with maintaining the stability, efficacy and integrity of a drug formulation or the need to answer the ever more demanding range of manufacturing, commercial and environmental requirements that underpin the industrial landscape today.
A case in point is the continued growth across biologics, biosimilars, biotech and vaccines as well gene therapies and mRNA whose complex properties place additional layers of pressure on both the performance of primary packaging and the effectiveness of Fill & Finish operations. For manufacturers, managing these typically high-value and small-batch drug products means implementing a flexible production strategy that provides control over the many variables that have the potential to compromise the process. This means addressing the risk of vial breakage, which can lead to product wastage and lost productivity, and the risk of particle contamination, which can trigger a costly product recall. In addition, manufacturing must be conducted at an optimum scale, efficiency and yield.
A smart approach to manufacturing processes.
In the context of these growing pressures, ready-to-use (RTU) containers are experiencing growing demand. Because they are supplied pre-washed and pre-sterilized, these components are ready to be integrated directly into aseptic Fill & Finish lines, avoiding the requirement for several preparation procedures to be carried out, including washing, drying and depyrogenation.
At Stevanato Group, our EZ-fill® platform has long set the industry standard for pre-sterilized RTU containment solutions. More recently, we were proud to launch EZ-fill Smart™ as an evolution of this platform, which incorporates a series of enhancements in both packaging and processes that have been designed to further strengthen the EZ-fill® proposition for manufacturing partners.
EZ-fill Smart™ brings direct benefits to drug manufacturers in terms of production efficiency since the various processes involved in sterilization are all managed by Stevanato Group before vials enter the live production environment. As such, pharmaceutical companies can rely on an experienced external partner to control these non-core processes, easing the burden on their workflow and facilities, freeing up operational time and clean-room space, and reducing overall costs. Our well-established relationships with all major Fill & Finish machine vendors also ensure that RTU vials from Stevanato Group facilitate seamless integration with flexible batch production on existing Fill & Finish lines.
The use of RTU vials also has important benefits in terms of reducing the risk of particulate contamination, which is an increasing area of concern for regulatory bodies, as exemplified by the introduction of the revised GMP Annex 1 for the manufacture of sterile medicinal products in the European Union. This is achieved through the removal of these processes during Fill & Finish, which limits the potential for glass-to-glass contact - a known contributor to particle generation.
This issue is further addressed through the secondary packaging of EZ-fill Smart™ packaging. In typical secondary packaging, there is potential for foreign particles to be generated as the Tyvek sheet covering the tub and tray is peeled away. To address this issue, EZ-fill Smart™ replaces the Tyvek lid with a transparent polymer film, leading to > 90% reduction in the risk of particles being generated as part of operational activities.
Supplying vials in a ready-to-use state can therefore be seen to have benefits for formulation integrity through the minimization of vial handling, but it is also the case that this feature has benefits for production efficiency. Despite the inherent physical strength of glass, excess or careless handling creates the potential for structural damage. This not only impairs aesthetic appearance, but it can also result in surface defects and a decreased ability to withstand physical impacts or thermal shocks. In turn, this can lead to breakages and line-stops during Fill & Finish operations or a higher scrap rate if inspection procedures highlight the presence of defective products.
Realizing smart savings vs conventional packaging containers.
For the manufacturer, each of these problems carries a cost, whether that’s in terms of product wastage, production downtime or slower time-to-market. In contrast, with a higher quality of product, there is greater repeatability of process and improved levels of manufacturing efficiency.
In addition, RTU solutions deliver further cost savings for manufacturers by eliminating sterilization processes, avoiding investment in equipment and ongoing utility charges. Together, all these factors unequivocally result in a up to 45% total cost savings versus the conventional packaging containers over a period of 8-10 years.[1]
Smart also means sustainable.
Of course, financial savings are not the only benefit that comes from reducing energy consumption. At Stevanato Group, we support the premise that sustainability should be a critical consideration for any manufacturing process, and we are serious about our responsibility to reduce our own environmental impact and to help our customers do the same. This thinking is infused within EZ-fill Smart™, which not only employs alternative biopolymers and recycled materials but also employs an alternative sterilization method, demonstrating alignment with the current regulatory direction to replace Ethylene Oxide Processing (EtO).
In summary, there are many factors to consider when evaluating a containment solution, but with EZ-fill Smart™, manufacturers do not have to compromise on any of them. As a platform, it is true to a philosophy of progress, not only enhancing drug integrity and production efficiency but also reducing total cost of ownership and contributing to a more sustainable future.
For further information on EZ-fill SmartTM please visit the Stefanato Group website page: EZ-fill Smart - Stevanato Group
To download the EZ-fill Smart brochure click here.