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