News
11 Mar 2021
Toxic-sterile isolator for preparation vessel charging
How to weigh and dispense a high potent serile 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: weigh & charge an 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; )- Risk of cross-contamination from 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 product in the dispensing chamber (Grade A maintained )- Vessel charging.
Description of FPS custom solution: - Custom isolator with integrated VHPH system & H14 HEPA filtration; - Product kept sterile during the entire process (positive pressure); - Isolator switches to negative pressure during CIP/WIP to protect the operator; - Special connection between isolator and Process vessel for accurate weight
Contact us for more information on toxic-sterile Isolators for preparation vessel charging!
[email protected]
Mentioned Companies
FPS Food and Pharma Systems S.r.l.
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