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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