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GSK | Worthing, United Kingdom
Blender charging and final filling of bulk antibiotic powder in entirely aseptic conditions, using isolation technology, with the highest operational efficiency, and a fully automatic process.
Performance Requirements – GSK GlaxoSmithKline
- Three multi chamber lines to handle aluminum containers in the different process phases
- Maximum use of automation to avoid human intervention
- Autoclave integrated with isolator line
- First of a kind filling accuracy in the application as well as mandatory “no powder” in isolator, to prevent explosion-proof classification
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:
- 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
Isolator or RABs?
An ISOLATOR is a barrier systems well defined (physical) that can be validated to provide significant risk reduction of bio-contamination. An isolator provides an uncompromised, continuos, Grade A isolation of its interior from the surronding environment.
A RABS is a combinations of physical and aerodynamic barrier over the aseptic process zone. RABS is an alternative contamination control methodology designed to be used in a higher classification cleanroom (EU Grade B – ISO 7 minimum) and based on systems of less engineering complexity.
Why Comecer prefers the isolator?
Given the complete separation between the operators and the aseptic area, the isolator solutions are 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.