Microbial Contamination of Pharmaceutical Products – Part 2
Description:
Upon completion of this course you will have a greater understanding of the following, the basics of applied pharmaceutical microbiology, the sources of microbial contamination and their control, how to implement appropriate strategies for maintaining a controlled manufacturing environment, new technologies and rapid microbiological methods, microbial identification technologies, endotoxin testing for quality control and process control during manufacturing, microbiological test method validation and the regulatory and pharmacopoeial expectations.
Curriculum for this course:
Introduction
Overview | 1 min 10 secs |
Learning objectives | 58 secs |
Who should take this course? | 1 min 23 secs |
Terms explained | 1 min 42 secs |
Course modules | 1 min 10 secs |
Module 3: The Essentials of Pharmaceutical Microbiology
Microbiological culture media | 1 min 05 secs |
Microbiological culture media | 1 min 08 secs |
Other culture media | 1 min 10 secs |
Microbiological examination of non-sterile products | 1 min 09 secs |
Test methods | 1 min 11 secs |
Microbial enumeration test (MET) | 1 min 13 secs |
Tests for specified microorganisms | 1 min 02 secs |
Acceptance criteria for non-sterile pharmaceutical products | 58 secs |
Microbial examination of sterile products – Endotoxin test | 1 min 10 secs |
Microbial examination of sterile products – LAL Test | 1 min 14 secs |
Principle of the LAL Test | 1 min 05 secs |
The FDA’s recommended LAL method | 1 min 06 secs |
Comparison of methods | 1 min 15 secs |
Microbial examination of sterile products – sterility test | 1 min 12 secs |
Types of media | 1 min 18 secs |
Sampling | 1 min 07 secs |
Sterility testing methods | 1 min 10 secs |
Direct inoculation | 1 min 21 secs |
Interpretation of results | 1 min 18 secs |
Sterility Failures: What happens next? | 1 min 15 secs |
Laboratory system investigations | 1 min 01 secs |
Manufacturing system investigations | 1 min 04 secs |
Concluding sterility test failure investigations | 1 min 08 secs |
Antimicrobial effectiveness test | 1 min 19 secs |
Product categories | 1 min 22 secs |
Test organisms | 1 min 02 secs |
Media | 1 min 11 secs |
Procedure | 1 min 17 secs |
Criteria for antimicrobial effectiveness | 1 min 05 secs |
Module 4: Validation of Microbiological Test Methods
What is method validation? | 1 min 22 secs |
Principle | 52 secs |
Types of microbiological methods | 1 min 12 secs |
Validation parameters | 1 min 30 secs |
Validation parameters per test | 1 min 42 secs |
Module 5: Microbiological Environmental Monitoring
What monitoring can do? | 1 min 22 secs |
Methods of monitoring | 1 min 17 secs |
Active air sampling | 1 min 29 secs |
Active air sampling – method | 1 min 31 secs |
Passive air sampling (Settle plates) | 1 min 39 secs |
Passive air sampling (Settle plates) – method | 1 min 50 secs |
Contact plates | 1 min 55 secs |
Contact plate – method | 47 secs |
Swabs | 1 min 50 secs |
Swabs – method | 52 secs |
Monitoring frequencies | 1 min 29 secs |
Limits for microbiological monitoring | 1 min 40 secs |
Some tips for microbiological monitoring | 1 min 33 secs |
Conclusion
Final Assessment
Certification
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