FAQ

Yes. Our co-extruded films feature a high-purity ULDPE liquid contact layer engineered for exceptionally low extractables. We provide comprehensive data packages to support your chemical compatibility assessments and bioprocess safety validations.

We offer full customization to meet diverse bioprocess requirements . This ranges from specific dimensions for our 2D/3D Single-use Storage Bags to fully tailored single-use tubing assemblies , ensuring seamless integration for your buffer preparation and intermediate harvesting processes.

All critical manufacturing steps occur within our ISO 9001 certified and GMP compliant Class 7 Cleanrooms. Our 100,000-ton medical-grade production line operates under strict environmental controls to guarantee high biocompatibility and low particulate counts across all products.

We maintain absolute transparency and traceability. We provide comprehensive reports, including EN868-2:2025 analysis, In Vitro Viral Tests, and Hemocompatibility data . Furthermore, we offer dedicated packaging validation and material testing services to ensure your regulatory compliance.

Our 100% HDPE flash-spun material delivers outstanding tear strength and burst resistance that remains highly stable post-sterilization. It provides a superior microbial barrier while remaining fully compatible with Gamma, EB, EO, VHP, and conditional Steam sterilization .

faq

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