Bacterial Endotoxin Testing: The LAL Assay
Mitigating risk to patients and complying with regulatory standards is vital in the pharmaceutical and biomedical industries. One crucial aspect of risk management is to ensure that any parenteral medicines and implantable devices released to the market are not contaminated with harmful bacterial endotoxins. As an essential requirement of current Good Manufacturing Practices (cGMP) and other quality control regulations, many companies use LAL testing to detect the presence of endotoxins in their products throughout the manufacturing processes. Often, companies will also test the raw materials for endotoxins before manufacturing begins, to meet Quality by Design criteria and assure low or negligible endotoxin content in raw material if possible.