Scale-up exercises are often problematic and lead to substantial losses of material and time. It is the goal of VSL to facilitate scale-up by doing it “Right First Time”. For this purpose VSL consists of a site specific set of individual VES, matching the equipment of Research &Development (R&D-VES set) and the Manufacturing Departments (M-VES set). Thus, a VSL consists of a set of R&D-VES and a set of M-VES.
Thus VSL replaces in silico the site specific equipment, for example small and large scale mixers/granulators, small and large scale fluidized bed dryers etc. The VSL- site specific software package takes into account the site specific manufactured formulations and the experience obtained with these formulations during the previous scale-up exercises and the records of batches manufactured for existing and new formulations. Thus the site and formulation specific scale-up factors can be quantified and exploited for an easy launching of new products.
Advantages:
- Individual training of lab staff using the actually existing small and large scale equipment.
- Better understanding of the processes and the product properties
- Thanks to a better process understanding the number of batches to be rejected can be minimized.
- Cost savings
- Scale-up exercises for new products are facilitated.
- Reduction of “time to market” can be expected.
- Thanks to a better process understanding the batch to batch quality can be improved
- Possible changes in the quality between small scale and large scale batches can be avoided.
Large pharmaceutical companies having manufacturing sites in different locations may be interested in establishing site specific M-VES. Thus problems and costs of change of manufacturing sites can be reduced substantially.
