Establishing multivariate specifications for incoming materials using data from multiple scales

The effects of the raw materials onto the productʹs final quality attributes (FQA) will be combined with the effect from the process operation, and from any differences of scale. A new mathematical framework is proposed to help understand and decouple the effects of raw materials, scale, process conditions and control system onto the FQA for a given product. Ultimately it provides a quantitative way to establish a quality driven multivariate specification for the incoming materials, using data from multiple scales to support it. The new technique is based on multivariate latent variable methods (LVM) coupled with optimization techniques. This proposed method can be used as the basis to quantitatively support a design-space definition that takes into account the inherent variability in the FQA that is brought in by the process operation, the control system and the materials. The methodology is illustrated herein building a multivariate specification for the purchase of a polymeric excipient for the production of tablets.