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Lifemeta™ FCS Single-Use Filling Needle, 10/pk

In stock
Part No. FCS0620
$1,143.00 USD
Size
Sterilization
Package
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*Not for medical use

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 biopharmaceuticals
  • High-performance drug filling
  • Blood products filling
  • Vaccine filling

Quality Assurance

  • ISO™ 9001: 2015 Quality Management System
  • ISO Class 7 clean zones
  • 316L passivated Stainless Steel Needle + Animal Derived Component Free (ADCF) Polysulfone
  • Meet the requirement of USP <87> In Vitro Biological Reactivity Test
  • Meet the criteria of the USP <88> Biological Reactivity Test for Class VIl plastics
  • Aqueous extraction contains <0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL), USP <85>
  • Particulate matter in the product eluent meets the requirements in USP <788> for small volume parenterals
  • Provide Extractables and Leachables Testing Report
Material Needle 316L Stainless Steel
Physical Properties Filling Volume >0.1 mL to >30 mL
Biological Safety Aqueous Extraction <0.25 EU/ml
Sterility Delivery Condition Non-sterile / Sterile Individually Packed
Sterilization Option

Gmma Irradiation: 25-45 kGy in a sterile package and can not be re-sterilized.

Autoclave (135°C): 90 min
Package Pack Size 10 pcs/pk

 
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