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
Properties | ASTM method | ASTM method |
Hardness: 15 seconds tested by Shore A hardness tester | D2240 | 59 |
Tensile strength psi | D412 | 860 |
Elongation at break 100% | D412 | 280 |
Biocompatibility
Validation items | Regulations and standards |
Bacterial endotoxin | USP 85 |
Biological reactivity test - in situ vitro | USP 87 |
Biological reactivity test - in situ vivo | USP 88 |
Elastic sealant for injection | USP 381 |
Physicochemical properties of plastics | USP 661 |
Insoluble particles | USP 788 |
Genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993 3 |
Test selection for interaction with blood - in vitro blood compatibility | ISO 10993 4 |
In vitro cytotoxicity test | ISO 10993 5 |
Stimulation and sensitivity test - Kligman maximization test | ISO 10993 10 |
Systemic toxicity test | ISO 10993 11 |
Rubber products | FDA 21 CFR 177.2600 |
Sealing and pipe testing of silicone elastomers | EP 3.1.9 |
Extractables | BPOG |
Ordering information
No. | Internal diameter (mm) (inch ) | External diameter (mm) (inch ) | Wall thickness (mm) (inch ) | Length (m) |
SUS-TPE-0125-0250 | 3.18 1/8 | 6.35 1/4 | 1.59 1/16 | 15 |
SUS-TPE-0188-0313 | 4.76 3/16 | 7.94 5/16 | 1.59 1/16 | 15 |
SUS-TPE-0188-0375 | 4.76 3/16 | 9.53 3/8 | 2.38 3/32 | 15 |
SUS-TPE-0250-0375 | 6.35 1/4 | 9.53 3/8 | 1.59 1/16 | 15 |
SUS-TPE-0250-0438 | 6.35 1/4 | 11.11 7/16 | 2.38 3/32 | 15 |
SUS-TPE-0250-0500 | 6.35 1/4 | 12.7 1/2 | 3.18 1/8 | 15 |
SUS-TPE-0313-0500 | 7.94 5/16 | 12.7 1/2 | 2.38 3/32 | 15 |
SUS-TPE-0375-0500 | 9.53 3/8 | 12.7 1/2 | 1.59 1/16 | 15 |
SUS-TPE-0375-0563 | 9.53 3/8 | 14.28 9/16 | 2.38 3/32 | 15 |
SUS-TPE-0375-0625 | 9.53 3/8 | 15.88 5/8 | 3.18 1/8 | 15 |
SUS-TPE-0500-0688 | 12.7 1/2 | 17.46 11/16 | 2.38 3/32 | 15 |
SUS-TPE-0500-0750 | 12.7 1/2 | 19.05 3/4 | 3.18 1/8 | 15 |
SUS-TPE-0625-0875 | 15.88 5/8 | 22.22 7/8 | 3.18 1/8 | 15 |
SUS-TPE-0750-1000 | 19.05 3/4 | 25.4 1 | 3.18 1/8 | 15 |
SUS-TPE-0750-1125 | 19.05 3/4 | 28.57 1-1/8 | 4.76 3/16 | 15 |
SUS-TPE-0750-1250 | 19.05 3/4 | 31.75 1-1/4 | 6.35 1/4 | 15 |
SUS-TPE-1000-1375 | 25.4 1 | 34.92 1-3/8 | 4.76 3/16 | 15 |
Copyright © Shanghai Duoning Biotechnology Co., Ltd. All Rights Reserved. | Sitemap | Powered by: