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Le-Flex® TPE Tubing

Short Description:

Le-Flex® TPE Tubing, independently developed and produced by LePure Biotech, has good biosafety and excellent physical and chemical properties. It fully meets the heat sealing and welding demands for the liquid management in biopharmaceutical process, and ensures the system integrity and sterility. Manufactured in a Grade C clean plant, Le-Flex® TPE Thermoplastic Pipe has excellent and stable production supply and quality assurance.


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Product Description

Le-Flex® TPE Tubing is used for aseptic disconnection and connection (tubing sealer), and mainly for culture medium and buffer preparation, cell culture, and sterile liquid transport when connecting to single use components or bags.

Advantages

Sterile thermal welding with mainstream products in the market
Excellent anti-gamma yellowing performance
Lower content of extractables and particles, which conforms to regulatory requirements
Offered in pre-assembled custom in advance, and provide liquid transfer integrity solution
Robust supply chain to cope with strong market growth
With related validation documents conforming to regulatory requirements, ensuring safe quality
Operating temperature range: -60℃ to 135℃
ADCF: animal-derived component free

Performance Parameters

Physical parameters
Test standard Test item

Test result

    Pre-gamma radiation Post-gamma radiation
ASTM D2440 Hardness 59-61 Shore A 57-59 Shore A
ASTM D412 Tensile strength 14.5 MPa 12.6 MPa
ASTM D412 Elongation at break 758% 753%
ASTM D412 100% stress at definite elongation 1.9 MPa 1.6 MPa
ASTM D412 300% stress at definite elongation 3.5 MPa 3.3 MPa
ASTM D624 Tear strength 30 KN/m 29.8 KN/m
ASTM D412 300% of tensile set 12% 16%
ASTM D395 Compression set “B”(22hrs, 70°C) 61% 63%
ASTM D746 Brittleness temperature test -70°C -66°C

 

Pharmacopoeia compliance  
Test standard Test item Test result
USP<661> Physico-chemical tests Passed
USP<788> Insoluble particles tests ≥10 μm: ≤10 particles/mL
    ≥25 μm: ≤l particles/mL

 

Biocompatibility
Test standard Test item Test result
ISO 10993-4 Hemolysis Pass
ISO 10993-5 Cytotoxicity Pass
ISO 10993-6 Implantation Tests Pass
ISO 10993-10 Irritation and Sensitization Tests Pass
ISO 10993-11 Acute Systemic Toxicity tests Pass
USP<85> Bacterial Endotoxin tests Pass
USP<87> Biological Reactivity Tests, in vitro Pass
USP<88> Biological Reactivity Tests, in vivo, class VI Pass

Specification Parameters

Item No. Inner diameter × outer diameter (mm) Inner diameter x outer diameter (inch) Packaging specification
LF-0125-0250 3.2 × 6.4 1/8 ×1/4 15 m/volume; double packing
LF-0188-0313 4.8 × 8.0 3/16×5/16 15 m/volume; double packing
LF-0250-0375 6.4 × 9.6 1/4 × 3/8 15 m/volume; double packing
LF-0250-0437 6.4×11.1 1/4×7/16 15 m/volume; double packing
LF-0250-0500 6.4×12.7 1/4 ×1/2 15 m/volume; double packing
LF-0375-0625 9.6×15.9 3/8×5/8 15 m/volume; double packing
LF-0500-0750 12.7×19.1 1/2 × 3/4 15 m/volume; double packing
LF-0750-1000 19.1×25.4 3/4×1 4.5 m/volume; double packing

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      Data-EN-Le-Flex® datasheet-20220803
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