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Important Variables
Characterisation of the process parameters that influence the outcome of each unit operation is a pre-requisite for optimisation and for validation. Safety, productivity and economy are important overall goals. A very important aspect of method optimization is to assure that robustness is designed into the process from the very beginning. Avoiding batch failure is more important than squeezing the most out of the process.
Robustness will assure scalability and consistent performance at final production scale.
In general you should consider optimising the following areas:
- Productivity
- Capacity
- Speed
- Recovery
- Sources of variation
- Process parameters
- Raw material
- Equipment
- Cost
- Processing liquid
- Type of media (e.g. bead size)
- Hardware
- CIP
- Purity
- Selectivity
- Efficiency
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