In Process Hardness Test Automation for Tablet Compression Process

Abstract

This article describes requirements to implement new hardness tester. The instrument was specifically for a dedicated product in the compression process area of a pharmaceutical operation. The challenge was to demonstrate reproducibility between hardness testers. The specific requirement was to identify a new way to assure the in process testing is completed as required. Actual instruments Vankel Hardness Tester was not feasible for modification in order to achieve requirements related to automation of the hardness testing to prevent human error. A project was approved for new Sotax Hardness Testers. The new instruments were required to be an automatic system with the purpose of improve reproducibility and reduce human error in test and documentation. A report must obtain only if in process testing is complete. It was also required to identify and report hardness values out of specification. Pharm grade instrument requiring stainless steel housing. Units must be Strong-Cobb (SC). Key Terms – Automation, Hardness Tester, In Process Testing, Strong-Cobb (SC).