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产品描述(Product Details)
The Cytokine Vial Adapter 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.
Cytokine Vial Adapter is designed to transfer lyophilized powder or liquid from a glass vial into a media bag seamlessly.
This vial adapter is compatible with glass vials that have a 13mm outer mouth diameter, such as 2R and 4R vials.
Intended Use: Aseptic transfer of lyophilized powder or liquid under a Class C environment.关键部件(Key Components)
- Sterile Syringe
- 3-way valve
- Vial adapter (13mm)
- 0.22μm sterile filter
- Check valve
- Weldable 20cm 3/32’’ x 5/32’’ PVC tubing
质量标准(Quality Standards Overview)
- ISO 13485:2016 & ISO 10993 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: <0.25 EU/mL (FDA LAL validated)
- Full-process QC per specifications/SOPs, records reviewed
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