However, contamination within a WFI unit presents the greatest challenge to maintaining a high-quality water system. In this second part of a series addressing endotoxin testing in the production process, we will explain how water systems become contaminated and how to best monitor system performance, manage data, qualify new systems an d trend results. Dr. James F. Cooper and C. Scott Polk Overview .
Water is the principal source of endotoxin in parenteral products.
Fortunately, twenty years of experience in the industry has failed to substantiate this concern. This discussion addresses LAL methods, sampling plans and trend analysis used in qualification and maintenance of a pharmaceutical water system. Realistic alert and action limits may be set on a local level based on historical data and process capability. Representative limits adopted by parenteral firms are presented in Table 1. Ideally, endotoxin levels are measured and reviewed at suitable intervals to discover changes in endotoxin levels before they become problematic.