Toxic-sterile Isolator for preparation vessel charging

FPS present the Toxic-sterile Isolator for preparation vessel charging 

How to weight and dispense a HIGH POTENT STERILE into a process vessel?

How to maintain the API sterility and protect the operator without using PPE?

How to avoid cross contamination from processing different products?

 

Process:

Weight & charge a HPAPI into a process vessel in Grade A-ISO 5 conditions

What are the issues?

  • Keep the product sterile during the process (10-6 SAL)
  • Protect the operator from High Potent API (OEB 5)
  • Handling heavy bags can create back injuries
  • Risk of cross contamination from processing different products

Process steps:

  • Introduction of products and tools in the pre-chamber
  • Decontamination cycle with VHP of pre-chamber, Grade A (Class 100)
  • Weighing of the products in the dispensing chamber (Grade A maintained)
  • Vessel charging

Benefits of FPS Solution:

  • No risk of exposure for the operators
  • No need to use PPEs: better ergonomics, higher productivity
  • Assure sterile conditions, Grade A inside each isolator chamber by integrated VPHP system
  • Isolator operates both in positive and negative pressure regime
  • Isolator-Vessel connection doesn’t interfere with loading cells

Description of FPS custom solution:

  • Custom isolator with integrated VHPH system & H14 HEPA filtration
  • Product kept sterile during the entire process (positive pressure)
  • Integrated CIP/WIP to avoid cross contamination
  • Isolator switches to negative pressure during CIP/WIP to protect the operator
  • Heavy bags moved by a stainless steel cart inside the isolator
  • Process vessel has loading cells for accurate weight
  • Special connection between isolator and Process vessel:
    • to assure containment and sterile conditions
    • to avoid affecting the load cells

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