This video demonstrates the authentication of pharmaceutical tablets using Sagitto's miniature NIR instrument and an iPad Mini, connected to Sagitto's cloud-based machine learning models. Two models are demonstrated - Viagra, and Ponstan.
The following reports were generated during the making of this demonstration.
Raw Material Identification (RMID)
Good Manufacturing Practice (GMP) guidelines specify that "manufacturers of finished [medicinal] products are responsible for any testing of starting materials as described in the marketing authorisation dossier. They ... must, as a minimum, perform identification testing of each batch themselves ... ” Section 5.33, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
Sagitto has developed an example model, using common pharmaceutical excipients such as microcrystalline cellulose and lactose monohydrate, to illustrate how its system can be used to provide a rapid and cost effective solution to manufacturers wishing to conduct raw material identification. This example model demonstrates that the Sagitto system can not only distinguish between different types of raw material, but can even identify individual manufacturers of the same raw material.
Here is an example report produced by this model.