Description
E.SAENG EM304 Film is an environment-friendly non-PVC film for IV solution bag primary packaging with the very low tolerances under the internationally certified level of strict clean room conditions and has been produced in a variety of formulations to comply with the following highest level of product qualities in the world
- Polypropylene based multilayer film
- Minimizes particulate with tubular typed co-extrusion
- Excellent impact strength
- Sterilizable at 121 °C for 30 min.
- Excellent heat sealing properties
- Complies with USP (U.S.A) and SFDA (China) requirements
- Low water vapor transmission rate (WVTR)
Structure
- Skin layer : Thermal resistance/Printability
- Core layer : Impact strength/Low temp. resistance/Adhesive properties
- Inner layer : Good sealing properties/Sterilizable at 121 °C
2) Physical properties :
Approval & Certification
USP |
USP Plastic Class VI for biological reactivity test Physicochemical test
Cytotoxicity using USP elusion method
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FDA
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complies with CFR 21 x 177.1520 |
SFDA
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Import package material for drug license (License No. J20020054)
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JP
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Edition 14 section 61 method for plastic containers |
ISO |
ISO rabbit pyrogen study In Vitro hemolysis study |
Dimension : Different film width available
- Available width : 135, 140, 160, 190, 220, 320 (in mm)
- Special width : other customized size also avaliable on request
Packing details
- Supplied in reels with tubular film or cut as lay-flat double wounded
- Core diameter : 6 inches (152.4 mm)
- Reels packed on pallet, wrapped with shrinkable PE film
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