ProSensus, Inc.

This technology can also be applied for final product quality

Multiple measurements on a lot of materials are seldom independent of each other, yet we almost always interpret these test results univariately; this is problematic.

Objective

Many properties are measured to characterize batches of raw materials (or final products). These properties are seldom independent of each other, yet we almost always interpret these test results univariately. This is problematic.

The problem with univariate measurements

The plot below shows two measurements taken on different batches of raw materials. The two measurements interact: as measurement 1 increases, the value of measurement 2 generally decreases - this is seen in the top left corner of the diagram.

The two time series plots (one vertical, one horizontal) show the two measurements for each batch.  These measurements are mostly between their upper and lower control limits; the UCL and LCL values. The red point from one batch is specially marked: this point lies between the limits for both measurements.  This point is with-in specification univariately, but multivariately, this batch is very different from the rest.

Multivariate assessment of raw materials (MVspec)

ProSensus has developed and deployed technology at pharmaceutical sites to avoid the problem of univariate specifications. These tools have been validated for use at these sites.

Our technology has these features:

• it is web-based, for deployment at all sites of your company, and requires no software installation on the user's computer.
• allows immediate visualization of the material before it is used or shipped to a customer.
• the material is placed in the context of previous good and bad batches, this allows one to validate the product's consistency from a multivariate point of view. 
  
• importantly, if the material if out-of-specification, the web-based tool will diagnose which properties were at problematic.
• MVspec can handle missing data, many measurements on the same lot, including spectral measurements such as a complete NIR scan.
  

Availability of the web-based tool (MVspec)

MVspec is available for deployment at your site.  Please contact us to request an internet demonstration and to answer any additional questions.