Bacterial Endotoxins Test

Case Study

Introduction

The bacterial endotoxins test (BET) and the limulus amebocyte lysate (LAL) test are mandatory quality control (QC) release tests for injectable drug products. Guidelines for the BET and monographs with endotoxin limits are included in major pharmacopeias.

Today, the US FDA recommends that Process Analytical Technology (PAT) be implemented as part of pharmaceutical manufacturing, which involves risk-based management at every step of the process. More companies are implementing in-line, on-line or at-line tools to provide them with real-time analysis on the manufacturing floor to build quality into process.

In-Process testing

During the manufacturing process, both production and QC are involved in the collection and testing of raw materials and in-process and end-product samples. Often, the results of the LAL test are not available to production staff within the short time frame required to proceed with downstream processing (e.g., endotoxin levels for in-process buffer solutions and water for production). A rapid turnaround of LAL test results is required to determine whether the endotoxin levels of in-process samples are within in-house limits before proceeding to the next step of the manufacturing process.

Case Study

A Six Sigma analysis was conducted by an objective third party consultant to analyze LAL test efficiency at a biotech company. The study analyzed the sample process flow and turnaround time for two sets of in-process buffer samples.

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Charles River