Mono-PE Tubular Pouch Instead of PE/PA/PE: SÜDPACK Develops Sterile Barrier System for Life Science Packaging

With an innovative mono-PE sterilization barrier solution for demanding life science applications, SÜDPACK Medica is now offering an alternative to PE/PA/PE multilayer structures. The solution combines high mechanical strength with reduced migration risks and is compatible with existing PE recycling streams. The development was based on the aim of achieving the performance of a PE/PA/PE structure without polyamide and other critical formulation components.

The requirements for packaging for life science applications are continuously increasing. In addition to product safety, process stability and regulatory compliance, aspects of the circular economy and resource efficiency are also increasingly coming into focus—even though the pharmaceutical industry is currently not fully subject to the applicable PPWR regulations. Against this backdrop, SÜDPACK Medica has developed a mono-PE sterilization barrier solution that can be used specifically as secondary packaging for process bags in sensitive cell culture and bioprocess applications.

The film protects the primary packaging from mechanical stresses and damage during transport, storage and handling. At the same time, the development pursues a new approach: Instead of using conventional PE/PA/PE multilayer structures, the solution is based entirely on polyethylene and does not contain polyamide, tie layers or other components that may potentially be migratable in conventional coextruded structures. The tubular bags produced on this basis are manufactured, among other locations, in the new ISO 7 cleanrooms in Coulmer.

New requirements for sterilization barrier systems

PE/PA/PE coextruded films have been an established standard for applications with high mechanical requirements for many years. While polyethylene supports sealability and processing properties, polyamide typically provides the necessary stability and strength.

However, potential interactions between packaging materials and sensitive biotechnological processes are being closely examined, particularly in the life science sector. Even small quantities of migrating substances may be considered critical in certain applications. Accordingly, the industry has called for packaging systems to be further developed and potential sources of contamination to be minimized.

Mechanical performance and low migration risk

Optimized according to cytotoxicity criteria, SÜDPACK Medica’s tubular bag solution consists of a new barrier system that achieves the mechanical and barrier performance of existing PE/PA/PE structures with a mono-PE solution. This was achieved through extensive raw material screening, targeted material selection and process engineering optimizations in the coextrusion process. According to internal tests, the film is characterized in particular by high puncture resistance, pronounced flex-crack resistance, as well as reliable processing and sealing properties. At the same time, transparency and optical quality remain at a high level.

What is more, this sterilization barrier system is currently the only solution on the market for this application that can completely dispense with critical, potentially migratable components of conventional PE/PA/PE coextruded films, such as caprolactam, antioxidants, slip agents and tie layers. This made it possible to develop a material concept specifically tailored to the requirements of sensitive process applications while also taking the industry’s regulatory expectations into account.

Contribution to the circular economy

In addition to the functional properties, environmental aspects were also a focus of the development. The mono-PE structure is compatible with established PE recycling streams, and its recyclability was calculated at 100% based on an internal assessment using CHIRA software.

Last but not least, a screening LCA conducted by SÜDPACK Medica shows a significant reduction of more than 50% in CO2e emissions compared with a corresponding PE/PA/PE structure. The results refer to the reference systems considered in the project and the underlying assumptions of the analysis.

With the development of the new mono-PE sterilization barrier solution, SÜDPACK Medica demonstrates that high mechanical performance, regulatory requirements and recyclability do not have to be mutually exclusive. The solution gives manufacturers of life science products another option for further developing existing packaging concepts with regard to future regulatory and technical requirements.