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产品描述(Product Details)
This Two-Ports Bottle Cap System is a precision-engineered solution designed for safe and efficient fluid transfer in critical applications, including biopharmaceutical processing, laboratory workflows, and sterile fluid management. This system ensures airtight sealing, contamination-free operation, and reliable performance, making it ideal for environments requiring strict aseptic conditions.
This Two-Port Cap System enables sterile liquid transfer between media bottles and cell culture bags.
This cap is applicable to the bottle of CelThera™ GMP T Cell Expansion Medium (Cat. No. GMP-CM3101 and Cat. No. GMP-CM3102) and other 38-430 thread bottles.
Intended Use: Aseptic transfer of cell culture media or other sterile fluids in controlled environments.关键部件(Key Components)
- Integrated Air Filter
- Fluid Transfer Tubing (Outlet Line): proximal weldable 60cm 1/8’’ x 1/4’’ TPE tube, distal weldable 20cm 3/32’’ x 5/32’’ PVC tube
- Luer connectors
- Internal Dip Tube
质量标准(Quality Standards Overview)
- ISO 13485:2016 & ISO 9001:2015 compliant
- TSE/BSE risk minimized per EMA/410/01 (Section 6.4)
- USP Class VI certified resins (tested per <87>/<88>)
- Sterile: ISO 11137 validated, SAL 10⁻⁶, dosimetric release
- Non-pyrogenic: <0.03 EU/mL (FDA LAL validated)
- DNase/RNase-free confirmed
- Full-process QC per specifications/SOPs, records reviewed
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