Pharmaceutical-grade silicone tubing is made from high-purity medical-grade silicone rubber raw materials using a platinum vulcanization process, featuring extremely low extractables and leachables, smooth walls without pores, and no odor or residue.
Product Structure
Main Material: High-purity medical-grade vapor-phase silicone rubber, deeply purified with metal ion content below the detection limit, and free of harmful substances such as plasticizers.
Process Characteristics: Platinum-cured technology ensures uniform molecular cross-linking, eliminating residual peroxides; the inner wall is smooth and dense, minimizing the risk of drug adsorption and contamination.
Product Advantages
Ultra-high Purity and Safety
Raw materials undergo three-stage vacuum distillation purification and are tested via ICP-MS, resulting in extremely low extractables and leachables with no harmful substance release, eliminating pharmaceutical contamination at the source.
Excellent chemical resistance
Resistant to common pharmaceutical reagents such as hydrochloric acid, sodium hydroxide, and ethanol, maintaining stability within specified concentration and temperature ranges without swelling or cracking.
Low adsorption and low loss
Smooth and dense tube walls minimize adsorption of drug active ingredients and proteins, reducing material loss and ensuring precise drug component ratios.
High-temperature and high-pressure resistance
Withstands 135°C high-temperature steam sterilization and pressures above 10 bar, meeting SIP process requirements, with stable performance after multiple sterilizations.
Product applications
API transportation
Used in the production of antibiotics, vitamins, etc., for transporting reaction solutions and solvents, resistant to acids, alkalis, and organic solvents, without affecting drug purity.
Formulation production
Used in the production of injectables and oral liquids to transfer pharmaceutical solutions. Its low adsorption reduces active ingredient loss, ensuring stable pharmaceutical quality.
Biopharmaceuticals
Suitable for vaccine and monoclonal antibody production, meeting sterile, pyrogen-free, and low endotoxin requirements. It is applicable for the transportation of cell culture media and fermentation liquids.
Pharmaceutical Equipment Accessories
Used as connecting tubing for freeze dryers, chromatography columns, and solution preparation systems, compatible with CIP/SIP processes, providing reliable fluid pathways.
About Us
We are a company specializing in the research, development, and production of silicone tubing for pharmaceutical processes. We have a 5,000㎡ standard factory with 160 employees, including a 30-member R&D team, with years of experience in the medical silicone field. The company has introduced advanced extrusion equipment and testing instruments, producing products in ISO Class 7 cleanrooms using platinum vulcanization technology. Each batch of products undergoes 15 stringent tests. We offer customized solutions such as anti-protein coatings based on dosage form requirements, providing pharmaceutical companies with high-standard fluid transfer solutions.
FAQ
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