COBETTER Lifemeta™ FCS Single-use Filling Needles
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| Brand | Accessory Brand | Lifemeta™ FCS Single-use Filling Needles |
| Physical Properties | Material | 316L |
| Filling Volume | >0.1 mL to >30 mL | |
| Biological Safety | Aqueous Extraction | <0.25 EU/ml |
| Bio-compatibility |
Meet the requirement of USP<87> In Vitro Biological Test; Particulate matter in the product eluent meets the requirements in USP <788> for small volume parenteral. |
|
| Sterilization Option | Gamma-irradiation | 25-45 kGy in a sterile package and can not be re-sterilized. |
| Autoclave(135°C) | 90 min | |
| Package | Delivery Condition | Non-sterile |
| Pack Size | 10/pk |
The Cobetter Lifemeta™ FCS Single-Use Filling Needle is an economical and unique filling solution for aseptic filling of liquids. The liquid contact portion is made of stainless steel and can withstand gamma irradiation or steam sterilisation, providing a complete solution for final filling and saving the cost and resources required for cleaning verification and validation.
Features
• Reduced turnaround time and cleaning time
• High speed filling from bottom to top
• Available in a wide range of diameters to suit a wide range of filling volumes
• Controlled bead generation for precise filling volume
Applications
• Liquid injectable drugs
• Pre-freeze-drying of biopharmaceutical
• High performance drug filling
• Blood products filling
• Vaccine filling
Quality Assurance
• ISO 9001:2015 quality management system
• ADCF raw materials, ISO 7 cleanroom production
• Raw material meet the requirement of USP <87> Class VI, Biological Reactivity Test, In Vitro (2020)
• Raw material meet the criteria of USP <88> Class VI, Biological Reactivity Test, In Vivo (2020)
• Endotoxin limit of WFI System <0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
• Particulate matter in injections meet the requirements in USP <788> for large volume parenterals
- Single-use_Accessories_Catalog_2.23 Download