• I-Flex thermoplastic tube

I-Flex thermoplastic tube

Product Description

Product specification

 

I-Flex thermoplastic tube, specially developed for the biopharmaceutical industry, can be used to transport high-purity fluids in the biopharmaceutical industry. It can be welded, heat sealed and molded.

 

Scope of application

 

·Cell culture medium     · Cell fermentation

·Disposable system        · Vaccine production

· Laboratory R & D

 

Product features

 

· Thermoplastic elastic material is specially developed for the delivery of pharmaceutical industry fluid, belonging to disposable biopharmaceutical tubing;

· The thermoplastic pipe material meets the standards of USP Class VI, FDA, ISO and European Pharmacopoeia 3.2.2.1;

· With good elasticity and translucent body, and it can be sterilized, heat sealed and heat welded;

· It does not contain silicone oil and animal derived ingredients;

· The smooth inner wall provides better flow performance, and the translucent color allows complete visual monitoring of the fluid;

· There are traceable product record numbers on the packaging bags and boxes, and the quality control procedures have been recorded;

· The specified length, size and package can be ordered on request.

· Insoluble particle test according to USP 788

· Avoid particles falling off when cutting woven reinforced tubing

· No animal derived ingredients

· Operating temperature range: -40 °C to 135 °C

· With high temperature and high pressure sterilization or gamma γ Radiation sterilization

· According to the method VDmax 25 in ISO 11137, sterility validation can be carried out by gamma ray irradiation.

· Traceable record batch, double packing, with marking on the package

· In line with documented quality control of ISO 9001:2015, with complete validation package provided on request

· Monthly monitoring and inspection of microorganisms and suspended particles in clean workshop, and pest free management in the factory and plants

 

Characteristic physical properties

 

PropertiesASTM methodASTM method
Hardness: 15 seconds tested by Shore A hardness testerD224059
Tensile strength psiD412860
Elongation at break 100%D412280

 

Biocompatibility

 

Validation itemsRegulations and standards
Bacterial endotoxinUSP 85
Biological reactivity test - in situ vitroUSP 87
Biological reactivity test - in situ vivoUSP 88
Elastic sealant for injectionUSP 381
Physicochemical properties of plasticsUSP 661
Insoluble particlesUSP 788
Genotoxicity, carcinogenicity and reproductive toxicityISO 10993 3
Test selection for interaction with blood - in vitro blood compatibilityISO 10993 4
In vitro cytotoxicity testISO 10993 5
Stimulation and sensitivity test - Kligman maximization testISO 10993 10
Systemic toxicity testISO 10993 11
Rubber productsFDA 21 CFR 177.2600
Sealing and pipe testing of silicone elastomersEP 3.1.9
ExtractablesBPOG


Ordering information 

 

No.

Internal diameter

(mm)   (inch )

External diameter

(mm)   (inch )

Wall thickness

(mm)   (inch )

Length (m)
SUS-TPE-0125-02503.18         1/86.35     1/41.59  1/1615
SUS-TPE-0188-03134.76          3/167.94      5/161.59         1/1615
SUS-TPE-0188-03754.76         3/169.53      3/82.38        3/3215
SUS-TPE-0250-03756.35          1/49.53      3/81.59        1/1615
SUS-TPE-0250-04386.35          1/411.11      7/162.38        3/3215
SUS-TPE-0250-05006.35           1/412.7       1/23.18         1/815
SUS-TPE-0313-05007.94        5/1612.7        1/22.38        3/3215
SUS-TPE-0375-05009.53          3/812.7        1/21.59        1/1615
SUS-TPE-0375-05639.53          3/814.28      9/162.38        3/3215
SUS-TPE-0375-06259.53          3/815.88        5/83.18          1/815
SUS-TPE-0500-068812.7         1/217.46     11/162.38         3/3215
SUS-TPE-0500-075012.7          1/219.05        3/43.18   1/815
SUS-TPE-0625-087515.88        5/822.22        7/83.18         1/815
SUS-TPE-0750-100019.05       3/425.4            13.18        1/815
SUS-TPE-0750-112519.05       3/428.57     1-1/84.76         3/1615
SUS-TPE-0750-125019.05        3/431.75     1-1/46.35          1/415
SUS-TPE-1000-137525.4             134.92      1-3/84.76          3/1615

 


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