COBETTER Lifemeta™ FCS Single-use Filling Needles

In stock
Part No. FCS0620
Size
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;

Meet the criteria of the USP<88> Biological Reactivity Test for Class VII plastics;

Meet the requirement of USP<85> In Limulus Amebocyte Lysate (LAL) 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

• 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

• Can be gamma irradiated at 25-45 kGy in sterile package or can be autoclaved for 90 minutes at 135°C

• Provide Extractables and Leachables Testing Report

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