SÜDPACK Medica has developed a mono-polyethene (PE) sterile barrier solution for life science applications, intended as an alternative to PE/PA/PE laminates.
The material is designed for outer packaging of process bags used in cell culture and bioprocessing applications.
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It protects primary packaging against mechanical stress and damage during transportation, storage and handling.
The offering is made completely from PE rather than a conventional PE/PA/PE laminate.
It does not use polyamide, adhesive agents or other potentially migratable substances used in conventional coextruded structures.
The film was developed to achieve the mechanical performance and barrier properties of a PE/PA/PE structure without polyamide or other critical formulation components.
SÜDPACK Medica said it used raw material screening, material selection, and changes to the coextrusion process.
The company added that internal testing found high puncture resistance, flex-crack resistance, and processing and sealing properties.
The tubular bag solution has been optimised to meet cytotoxicity criteria.
It uses a polyethene-only barrier system that SÜDPACK Medica said matches PE/PA/PE structures in mechanical performance and barrier properties.
The tubular bags are produced in new ISO Class 7 clean rooms in Coulmer, as well as at other facilities.
According to the company, the sterile barrier system does not contain caprolactam, antioxidants, slip agents, or adhesive agents.
These substances can be present in conventional PE/PA/PE coextruded films.
The mono-PE structure is compatible with established PE recycling streams.
The company reported a calculated recyclability rate of 100% following an internal assessment using CHIRA software.
A screening life-cycle assessment carried out by SÜDPACK Medica found that CO₂e emissions were more than 50% lower than for an equivalent PE/PA/PE structure.
The result depends on the reference systems and assumptions used in the analysis.
