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SÜDPACK Medica now offers an innovative mono-PE sterile barrier solution for demanding life science applications, providing an alternative to conventional PE/PA/PE laminates. The solution combines high resistance to mechanical stress with reduced migration risks and is compatible with existing PE recycling streams. The development process was driven by the goal of matching the performance of a PE/PA/PE structure without the use of polyamide or other critical formulation components.
Requirements for packaging used in life science applications are becoming increasingly stringent. Alongside product safety, process stability, and regulatory compliance, increasing attention is being paid to the circular economy and resource efficiency – even though the pharmaceutical industry is not currently subject to all PPWR requirements. Against this backdrop, SÜDPACK Medica has developed a mono-PE sterile barrier solution that is specifically designed for use as outer packaging for process bags in sensitive cell culture and bioprocessing applications.
The film protects the primary packaging from mechanical stress and damage during transportation, storage, and handling. At the same time, SÜDPACK Medica is taking a different approach: Rather than relying on conventional PE/PA/PE laminates, the solution is made entirely from polyethylene, eliminating the need for polyamide, adhesive agents, and other potentially migratable substances found in conventional coextruded structures. The resulting tubular bags are manufactured in the new ISO Class 7 clean rooms in Coulmer, among other facilities.
New requirements for sterile barrier systems
PE/PA/PE coextruded films have long been the standard for mechanically demanding applications. While polyethylene contributes to good sealing and processing properties, polyamide typically provides the necessary stability and mechanical strength.
In the life science sector, however, potential interactions between packaging materials and sensitive biotechnological processes are subject to close scrutiny. Even small amounts of migrating substances can be of serious concern in certain applications. This has led to an industry requirement to improve packaging systems and minimize potential sources of contamination.
Mechanical performance and low migration risk
SÜDPACK Medica’s tubular bag solution, optimized to meet cytotoxicity criteria, features a new barrier system made entirely of polyethylene that matches conventional PE/PA/PE structures in terms of mechanical performance and barrier properties. This was achieved through extensive raw material screening, targeted material selection, and optimizations to the coextrusion process. Internal testing has shown that the film offers high puncture resistance, excellent flex-crack resistance, as well as reliable processing and sealing properties. At the same time, it maintains high levels of transparency and optical quality.
The sterile barrier system offers another advantage: For this application, it is currently the only solution on the market that contains none of the migratable substances of concern found in conventional PE/PA/PE coextruded films, such as caprolactam, antioxidants, slip agents, and adhesive agents. The result is a material concept that is specifically tailored to the requirements of sensitive process applications and also takes the industry’s regulatory expectations into account.
Supporting the circular economy
In addition to functional properties, environmental considerations played a key role in the development process. The mono-PE structure is compatible with established PE recycling streams and has a calculated recyclability rate of 100%, according to an internal assessment using CHIRA software.
Notably, a screening life cycle assessment (LCA) conducted by SÜDPACK Medica showed a significant reduction of more than 50% in CO2e emissions compared with an equivalent PE/PA/PE structure. These findings are based on the reference systems examined as part of the project and the assumptions underlying the analysis.
By developing its new mono-PE sterile barrier solution, the company has demonstrated that high mechanical performance, compliance with regulatory requirements, and recyclability need not be mutually exclusive. SÜDPACK Medica’s solution gives life science product manufacturers another option for adapting existing packaging concepts to meet future regulatory and technical requirements.
