Comecer's fully automated aseptic handling & filling of bulk API powder in isolator technology

GSK - GlaxoSmithKline
Advanced Plant for Bulk Sterile Manufacturing
A case study of Comecer Pharma solutions
Advanced Plant for Bulk Sterile Manufacturing.
Comecer designed and built three fully automatic lines plus a component preparation isolator.
This project delivers an integrated turnkey solution never done before in any other scenario for the particular bulk sterile manufacturing application:
Highlights
- Automatic discharge station under aseptic condition
- Washing and drying in isolator
- Autoclave offloading with anthropomorphic robot under Grade A isolator
- A specially designed filling system, including a stellar valve to reach a ±25g accuracy on 10kg fill
- CIP and SIP automatic setup on all product contact parts
- Automatic overwrapping under Grade A condition
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: www.comecer.co...
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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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48014 Castel Bolognese - Italy
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