Contamination Control & Aseptic Techniques

An Introduction to Endotoxin Control

The purpose of this course is to provide a basic understanding of endotoxin, sources of endotoxin, and the means and methods of controlling endotoxin within a pharmaceutical manufacturing environment.

CEU Credits: 0.1
Course Code: ELM-709
Duration: 30 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning Objectives
Who Should Take This Course?
Terms Explained
What are Gram-Negative Bacteria?
What is Endotoxin?
Why is Endotoxin Important?
Endotoxin Control
Methods of Controlling Endotoxin
Sources of Endotoxin – Overview
Raw Materials – Outside Vendors
Raw Materials – In-House Control
Container Closure System – Multidose and Unit Dose
Water and Clean Steam Systems Part 1
Water and Clean Steam Systems Part 2
Equipment Cleaning
Residual Water on Product Contact Surfaces
Equipment Defects and Design Flaws
Types of Endotoxin Testing - Overview
Gel Clot Method
Chromatogenic Method
Turbidimetric Method

Conclusion

Final Assessment

Certification

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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