• HPT platinum vulcanized silicone tubing

HPT platinum vulcanized silicone tubing

Product Description

Product specification

 

Bright black silicone tubing is produced in the clean workshop in accordance with ISO 14644 CLASS 7 requirements, and in accordance with the requirements of ISO 9001:2015 quality management system and GMP related regulations, with all links in the manufacturing process strictly controlled from receiving to production. With batch number specified, the inspection can be carried out and the traceability of the batch can be obtained.

 

The platinum vulcanized silicone tubings produced in clean room have the advantages of good stability and ultra-low volatility. They are specially designed and developed for one-time application of biopharmaceuticals. After being undergone physical, chemical and biological tests, HPT platinum vulcanized silicone tubings meet the USP, FDA CFR 177.2600, ISO 10993, and European Pharmacopoeia 3.1.9 standards. A complete BPOG standard extractable test is performed by a third-party testing laboratory.

 


Scope of application

 · Pharmaceutical and biotechnology processes · Ultra pure fluid transmission

·Disposable system        · Pipeline assembly

· Laboratory

 

Product features

 · Insoluble particle test according to USP 788

· No animal derived ingredients

· Operating temperature range: - 60 °C to 200 °C

· Resistant to extreme temperature, compression set, chemical attack, ozone, radiation, moisture and environmental exposure

· 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

· Complete validation package can be provided on request

· Monthly monitoring and inspection of microorganisms and suspended particles in clean workshop

· Pest free management in the factory and plants

 

Characteristic physical properties

 

PropertiesASTM methodASTM method
Hardness: 15 seconds tested by Shore A hardness testerD224050
Tensile strength psiD4121276
Elongation at break 100%D412760
Tear strength ppiD642266
Specific gravityD7921.17
Tensile modulus psiD412311

 

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-HPT-0063-0188


15
SUS-HPT-0094-0219


15
SUS-HPT-0125-0250


15
SUS-HPT-0125-0313


15
SUS-HPT-0125-0375


15
SUS-HPT-0156-0281


15
SUS-HPT-0156-0406


15
SUS-HPT-0188-0313


15
SUS-HPT-0188-0375


15
SUS-HPT-0250-0313


15
SUS-HPT-0250-0375


15
SUS-HPT-0250-0438


15
SUS-HPT-0250-0500


15
SUS-HPT-0313-0438


15
SUS-HPT-0313-0500


15
SUS-HPT-0375-0500


15
SUS-HPT-0375-0563


15

SUS-HPT-0375-0625





SUS-HPT-0500-0688



SUS-HPT-0500-0750



SUS-HPT-0625-0875



SUS-HPT-0750-1000



SUS-HPT-0750-1125



SUS-HPT-0750-1250



SUS-HPT-1000-1375



SUS-HPT-1000-1500




 



Related Products

Contact Us
  • Tel.: +86 21 6434 0155
  • E-mail: marketing@duoningbio.com
  • Add.: Building 30, 1525#, Minqiang Road, Songjiang Distriction, Shanghai
Follow Us

E-mail WeChat