Pre filled syringe filling line

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Introduction:

The use of PFS line is to fill sterile liquid product in to Glass/Plastic RTU nested syringes, the machine is suitable for products such as antibiotic, vaccine, blood plasma, oncology, monoclonal antibody, large molecule and so on. The filling process can be done under RABS or Isolator.

The full line is composed of:

  • De-bagger machine (Manual/Semi-automatic/Fully automatic)
  • De-lid &tyvekremoving machine
  • Filling and plunger stoppering machine

Salient Features:

  • Slim design, space-saving and easily to clean
  • Design follows cGMP, FDA, EU-GMP
  • The entire filling system is servo controlled allowing the critical motion parameters of the pump station
  • Filling and immediate closing
  • Liquid surface filling to prevent liquid splashing and foaming
  • Alternative Filling Systems(Rotary piston pump or peristaltic pump)
  • Alternative Stoppering systems(by insertion tube or vacuum)
  • RABS / Isolator – can be integrated
  • Data integrity conforms to the computerized system requirements,conforms to 21CFR part11, follow the GAMP 5 guidelines
  • Pre & Post Filling Nitrogen Flushing(Optional)
  • Latest Technology — Robot Technology
  • RTU & disposable Liquid filling method can be adopted
  • Filling range: 0.5 ml to 20 ml

 

 

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