Evaluation of Microbiological Cleanliness of Machines/Equipment through Rinse Technique Using Statistical Process Control

Abstract

To guarantee that patients receive safe therapy with predictable and acceptable medicinal properties, monitoring the quality standards in the healthcare sector and the pharmaceutical business, in particular, is essential. Medicinal products are no exception from these crucial characteristics and hence mitigation of the sources of microbial contamination is a mandatory strategy to avoid harming already-ill populations. Machines, equipment and tools that are used in the industry must be appropriately cleaned to ensure that they will not contaminate the product under processing. The study herein aimed to establish an evaluation system for cleaning efficiency through the rinse technique using Statistical Process Control (SPC) methodologies. A database was established and created for the recorded cleaning process over 20 months of the monitoring period. The control charts were constructed and evaluated from processed data using SPC software. A rare event control chart was used to track the cleaning process intervals with event probability estimated to be 0.080. Concerning the monitoring of the bioburden of rinse samples, the most appropriate fitting attribute chart is U type with Laney modification of over-dispersion to correct for tight control limits that increase alarming false points. Understanding the inspection property is inevitable for the right interpretation of trends.