Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

Charity Ogunsanya

Course description

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.

This accredited training will discuss the requirements of current USP <85> Bacterial Endotoxin Test (BET) European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). It will address the different LAL testing methodologies and how to choose the best test method applicable to the product type. This seminar will outline the importance, regulatory and testing requirements of products for compliance by applying the sequential steps in testing the product to rule out the presence of endotoxins.

This webinar will provide a great resource to companies in the Pharmaceutical, Biotechnology and Medical Device Industries that manufacture cGMP products requiring bacterial endotoxin release assay.

Upon completion of this course, you will be able to:

• Describe the steps involved in the performance of the different types of endotoxin test, when to use what method, the sensitivity of each chosen method.
• List the advantages and disadvantages of each method and how to identify, investigate and resolve false positive or negative results.
• Explain how the production and process controls of a manufacturing facility affect the product endotoxin levels.
• Determine or evaluate the state of control of a cleanroom and utility systems using the manufactured product’s bacterial endotoxin (LAL) test results.
• Use product bioburden test data to forecast a potential failure of a product’s LAL test result.