BioProcess International

Minimum Sample Size To Lock Control Limits? A Capability- and Risk-Based Approach Using PpK and Chi-Square Uncertainty

A quantitative approach for linking baseline sample size to statistics provides a statistically justified basis for ...
Nature

Statistical inference of the generalized process capability index for the discrete lindley distribution

For a stable and controlled process, “process capability” (PC) refers to the least quality variability that the process can provide. In other words, the PC is the measure of a process’s ability to ...
PharmTech

Using Process Capability for Statistical Evaluation of Cleaning Processes

This study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning. Pharmaceutical development ...
Nature

Batch production prediction for the mechanical cutting industry based on process capability

In the mechanical cutting industry, trial production is used for predicting and evaluating the quality of product processes before batch production, and it can be expressed through the qualification ...
PharmTech

The Statistical Evaluation of Cleaning Processes Using Process Capability and its Application to New Product Introduction

The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient ...