SÜDPACK Medica 推出面向生命科学包装的单一PE无菌屏障系统

23 October 2026

14:00

SÜDPACK Medica now offers a 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 per-formance 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 increas-ingly stringent. Alongside product safety, process stability, and regulatory compli-ance, increasing attention is being paid to the circular economy and resource effi-ciency – 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 pack-aging 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, ad-hesive 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 demand-ing 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 mate-rials and sensitive biotechnological processes are subject to close scrutiny. Even small amounts of migrating substances can be of serious concern in certain appli-cations. 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 conven-tional PE/PA/PE structures in terms of mechanical performance and barrier proper-ties. 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 cur-rently the only solution on the market that contains none of the migratable sub-stances of concern found in conventional PE/PA/PE coextruded films, such as ca-prolactam, antioxidants, slip agents, and adhesive agents. The result is a material concept that is specifically tailored to the requirements of sensitive process appli-cations 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 sys-tems examined as part of the project and the assumptions underlying the analysis.

By developing its new mono-PE sterile barrier solution, the company has demon-strated that high mechanical performance, compliance with regulatory requirements, and recyclability need not be mutually exclusive. SÜDPACK Medica’s solu-tion gives life science product manufacturers another option for adapting existing packaging concepts to meet future regulatory and technical requirements.