Course offering number:0802-703
Course ID:
2204
Endotoxin Testing: Resolving Interference and Test Validation
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training will benefit professionals in the pharmaceutical, biotechnology, medical devices industries; sterile
pharmaceutical compounding; and cellular and tissue therapy.
This course is applicable to microbiologists, chemists, and managers, supervisors and technicians concerned with
endotoxin testing in Quality Control departments as well as those in Quality Assurance, Regulatory Affairs,
Research and Development.
Description
Common causes of interference with the bacterial endotoxins test are presented in this course and specific
methods to eliminate them are given. Strategies for detecting interference; validation of special treatments to
overcome interference and validation of the test for endotoxins by performing the Pharmacopeial Test for Interfering
Factors are all addressed. Inclusion of these elements in an LAL testing program will result in compliant testing.
This 90-minute course will benefit both the experienced manager who has been supervising endotoxin testing and
the novice technician who wishes to understand and overcome interference with the test.
Module 1: Causes of Interference with the Limulus Amebocyte
Lysate (LAL) Test for Endotoxin
• Introduction
• Common causes for interference and their elimination
– pH; Salts; Chelating Agents; Proteins (including blood
serum and plasma); Agents that Denature Proteins; Agents
that Affect Endotoxin; Lipids and Liposomes
Module 2: Overcoming Interference in Endotoxin Testing
• Testing for Interference
• Strategies to Overcome Inhibition
– Dilution; Use of Buffer; Sample Treatments including: use
of other test methods, chemical modification and
ultrafiltration
Module 3: Validation of Sample Treatments and the Pharmacopeial Test for Interfering Factors for Validation of the Endotoxins Test
• The Test for Interfering Factors
– Gel-clot Method
– Photometric Methods
• Conclusion