Aseptic Handling and Filling of Bulk API Powder in Pharma with Comecer: Advanced Solutions

Описание: Comecer custom solution for your bulk sterile manufacturing. Given the complete separation between the operators and the aseptic area, the isolator solution is more likely implemented together with a certain level of automation when the batch sizes are significant. Same when the API has in some extent containment need the solution with isolator is a must. On the other hand RABs can be adopted when an extremely manual operation is carried out and no issue of containment is involved.

Insights
An isolator represents a well-defined physical barrier system that can be validated to significantly reduce the risk of bio-contamination. It ensures a continuous Grade A isolation within its enclosed environment, separated from the external surroundings. A RABS (Restricted Access Barrier System) combines both a physical and aerodynamic barrier within an aseptic process zone. RABS operates within a higher classification cleanroom (minimum EU Grade B – ISO 7) and generally involves simpler engineering systems compared to isolators.

Why does Comecer prefer isolators? Comecer favors isolator solutions due to their distinct advantages. With complete separation between operators and the aseptic area, isolators are ideal for scenarios with significant batch sizes, often integrated with automation. When dealing with APIs requiring containment, isolators become essential. Conversely, RABs are more suitable for highly manual operations with no strict containment requirements

More information: https://www.comecer.com/aseptic-handl...
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Comecer SpA - an ATS Company
Aseptic Processing and Containment Technologies: Comecer develops and manufactures high-tech systems in the field of Aseptic Processing and Containment for the Pharmaceutical and Nuclear Medicine Industries, specialising in isolation technology solutions for regenerative medicine and tissue engineering.

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