Product Features
- Proprietary TPE Material: Formulated with proprietary thermoplastic elastomer (TPE) base resin without silicone oil additives, significantly minimizing extractable and particulate precipitation.
- Comprehensive Size Range: Inner diameter (ID) specifications spanning 1/8″ (3.2 mm) to 3/4″ (19.1 mm), fulfilling standard bioprocessing fluid handling selection requirements.
- Dual Sterilization Compatibility: Validated for both gamma irradiation sterilization and autoclave/moist heat sterilization.
- Standardized Packaging & Shelf Life: Supplied in standard 5 m/pack and 15 m/pack packaging configurations with a 3-year product shelf life.
- Cross-Brand Heat Sealability & Welding: Proven compatibility for sterile heat welding with mainstream market TPE tubing, enhancing system versatility while reducing supply chain transition costs.
Application
Upstream Processing
- Sterile transfer of cell culture media, feeds, and buffers in cell culture and fermentation systems.
- Closed transfer of cell culture fluid and harvest fluids.
Downstream Processing
- Transfer of chromatography buffers, cleaning solutions, and process intermediates.
- Closed-system liquid transfer, sterile connection, and disconnection operations across purification steps.
Formulation, Fill & Finish and Advanced Therapies
- Sterile tubing assemblies for fluid transfer and dilution in monoclonal antibodies (mAbs), vaccines, ADCs, nucleic acid therapeutics, and Cell & Gene Therapy (CGT) workflows.
- Closed transport of intermediate bulk products and final bulk drug substance, as well as tubing setup for in-line process monitoring and control.
Key Advantages
- In-House Formulation & Indigenous Production: Full control over raw material formulation and complete localized manufacturing ensures a secure, resilient supply chain, mitigating supply disruption risks associated with imported tubing.
- Low Extractable & Low Particulate Profile: Silicone-oil-free design delivers reduced extractable and particulate levels, tailored for high-purity bioprocess applications demanding high cleanliness and consistent product quality.
- Cross-Brand Thermal Welding Compatibility: Seamlessly welds with mainstream commercially available TPE tubing without requiring adjustments to existing tube welders, sealers, or consumable frameworks.
- End-to-End Regulatory & Quality Support: Backed by a comprehensive validation package to support global regulatory filings (FDA, NMPA, EMA), reducing customer qualification workload and compliance risk.
- High Batch-to-Batch Consistency: Standardized process control guarantees excellent inter-batch reproducibility and process reliability.
- Superior Process Adaptability: Exceptional thermal welding and heat-sealing characteristics enable the construction of fully closed fluid management systems.
Quality Standards & Validation
- Quality Certification: Manufacturing facilities are certified by SGS and comply with ISO 9001:2015 Quality Management Systems.
- Raw Materials & Testing: Manufactured using medical-grade thermoplastic raw materials and validated across comprehensive parameters:
- Burst Pressure Testing
- Air Tightness / Leak Testing
- Bacterial Challenge Testing
- Elastomer Physical Property Testing
- Physicochemical Testing
- Extractables & Leachables (E&L) Testing
- Nitrosamine Impurities Analysis
- Sub-visible Particulate Matter Testing