Pharmaceutical Microbiology

Microbiological Contamination of Pharmaceutical Products – Part 2

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.

CEU Credits: 0.1
Course Code: ELM-706
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning objectives
Who should take this course?
Terms explained
Course modules
Microbiological culture media
Microbiological culture media
Other culture media
Microbiological examination of non-sterile products
Test methods
Microbial enumeration test (MET)
Tests for specified microorganisms
Acceptance criteria for non-sterile pharmaceutical products
Microbial examination of sterile products – Endotoxin test
Microbial examination of sterile products – LAL Test
Principle of the LAL Test
The FDA’s recommended LAL method
Comparison of methods
Microbial examination of sterile products – sterility test
Types of media
Sampling
Sterility testing methods
Direct inoculation
Interpretation of results
Sterility Failures: What happens next?
Laboratory system investigations
Manufacturing system investigations
Concluding sterility test failure investigations
Antimicrobial effectiveness test
Product categories
Test organisms
Media
Procedure
Criteria for antimicrobial effectiveness
What is method validation?
Principle
Types of microbiological methods
Validation parameters
Validation parameters per test
What monitoring can do?
Methods of monitoring
Active air sampling
Active air sampling - method
Passive air sampling (Settle plates)
Passive air sampling (Settle plates) – method
Contact plates
Contact plate – method
Swabs
Swabs – method
Monitoring frequencies
Limits for microbiological monitoring
Some tips for microbiological monitoring

Conclusion

Final Assessment

Certification

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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