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