Description
E-100 Technical data of Polyethylene Film
- Main applications areas: Biotechnology applications, high oxygen barrier
- Film thickness: 0.325mm (12.8mil)
- Formulation characteristics :
Multi layer structure with inert PE fluid contact layer,
low extractables / leachables.
No animal derived components.
- Pharmacopoeia compliancy and biocompatibility :
ISO 10993-4 Hemolysis
ISO 10993-5 Cytotoxicity
ISO 10993-6 Implantation test
ISO 10993-10 Irritaion and Sensitization tests
ISO 10993-11 Acute Systemic Toxicity test
USP <85> Bacterial Endotoxins – LAL Test
USP <85> Biological reactivity testing, in vivo, class VI
USP <661> Plastic Containers European Pharmacopoeia tests, Ch, 3.1.5
Copies of the test reports are available upon request.
Gamma sterilization dose 25kGy except **50kGy
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