Pharmaceutical Microbiology

Microbiological Testing Methods

Maintaining quality control during pharmaceutical microbiological testing plays an important role in ensuring the safety & efficacy of medications. This course provides an in-depth survey of microbiological testing techniques, including media choice, sterility testing, microbial limit testing, and endotoxin detection, with a focus on the robust quality control measures necessary to support a sterile and contaminant-free manufacturing environment.

CEU Credits: 0.1
Course Code: ELM-721
Duration: 20 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 01/06/2025

Curriculum for this course

A Small World With A Big Impact
The Importance of Pharmaceutical Microbiology
Quality Control Considerations for Microbiological Testing
Types of Media
Preparation and Sterilization of Media
Media Match!
Microbial Limit Testing
Tests for Specified Microorganisms
Acceptance Criteria For Non-Sterile Products
Endotoxin Testing
LAL Testing
LAL Method
Comparing Different LAL Methods
True or False?
Media Fill Studies
Membrane Filtration Sterility Testing
Direct Inoculation
Interpretation of Results
Sterility Failures: What Happens Next?
Validation Types and Parameters
Well-Being
Test your Knowledge!
v2.0 Major update on 2/18/2025. This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well. Additionally, course template was enhanced to provide more specific quiz completion data and a Version History document.
v1.0 Course released in 2021

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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