Pharmaceutical Microbiology

Ensuring Environmental Quality: A Guide to Microbiological Monitoring

Through a simulated contamination investigation in a pharmaceutical production facility, learners will explore the central role environmental monitoring (EM) plays in maintaining quality control of products through current Good Manufacturing Practices. The course covers key EM techniques, including active and passive air sampling, contact plates, swabbing, and best practices for setting monitoring frequencies and interpreting results.

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CEU Credits: 0.1

Course Code: ELM-719

Duration: 20 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V2.0

Effective Date: 01/24/2025

Curriculum for this course

Welcome

Health and Well-Being

Environmental Monitoring

Why Monitor?

EM Regulatory Expectations and Quality Control

Environmental Monitoring Frequency and Limits

EM Frequency

EM Limits

Monitoring Methods and Techniques

Change of Plans

Active Air Sampling

Active Air Sampling Findings

Passive Air Sampling

Settle Plate Placement

Passive Air Sampling Findings

Contact Plates

Contact Plate Findings

Swabs

Swab Findings

Conclusion

Follow The Evidence

Test your Knowledge!

Revision History

v2.0 Major update on 04/29/2025. This course has been redesigned. The redesign includes updated learning objectives and content. The visual design has also been updated.

v1.0 Course released in 2021