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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 Standards

  • ISO 9001: 2015 Quality Management System
  • ISO 7 cleanroom production
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • COA/COQ provided with shipment
  • Validation documents are available upon request
  • TSE/BSE certificate available
Physical Properties Product Name Lifemeta™ FCS Single-Use Filling Needle
Filling Volume >0.1 mL to >30 mL
Materials Needle 316L Stainless Steel
Coat Polysulfone (PSF)
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Sterility Delivery Condition Non-sterile - Autoclavable
Pre-sterilized
Sterilization Method Can be autoclaved for 90 minutes at 135°C
Pre-sterilized by Gamma irradiation at 25–45 kGy
Package Pack Size Pack of 10
Packaging Non-sterile: Bulk packed in double PE bag
Sterile: Individually packed in double PE bag


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