“Because Sterility Testing is a very exacting procedure, whereas asepsis of
the procedure must be ensured for a correct interpretation of results. It is
important that personnel be properly trained and qualified" - United States
Phamacopeia General Chapters
This two day course provides an in-depth review of the regulatory
requirements of sterility testing, its validation and practical
implementation. The course is based on the most recent editions of
pharmacopeias and provides information about the harmonization and
differences between the United States Pharmacopeia (USP) and the
European Pharmacopeia (EP).
Which of your challenges does this course address?
• Handling issues
• False positive test results
• Validating products with inhibitory activities – false negative test results
• Optimizing sterility testing procedures
In a hands-on interactive workshop, participants will learn how to perform
sterility test. Participants’ case studies will also be discussed. The
workshop will aid the understanding of the lecture contents with practical
applications. All the critical handling steps in the sterility testing
procedure and its consequences on test results are discussed and
solutions are explained and demonstrated.
Our experience trainers will also provide valuable suggestions to help
ensure regulatory compliance.
What will you be able to do after attending this course?
You will get a better understanding of the current requirements of
pharmacopeias and be familiar with good sterility testing procedures
from method development / validation through to routine test results
• Take preventive actions to avoid false positive or false negative test
• Develop and optimize sterility testing procedures
• Understanding and identify root causes for common handling issues
What will you receive?
• A full set of course notes
• Certificate of Achievement
Who should attend?
The course is designed primarily for quality control, manufacturing or
quality assurance personnel who perform or are responsible for the
performance of sterility test.
Hands-On Practical Section
The practical section covers how to:
• Use of Sterility Testing hardware
• Use of Sterility Testing consumables
• Demonstrate general specific sterility testing applications
• Troubleshoot specific user-related situations