Contamination Control & Aseptic Techniques

The Basic Principles of Isolator Technology

As technology is transforming from conventional clean room concept to barrier technology for aseptic processing and sterility testing, Isolators represent the systems of choice for optimizing product integrity, operator and environment safety. Isolators ensures a greater microbiological safety of the products, but at the same time requires thoughtful knowledge of Isolator technology and basic principles.

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CEU Credits: 0.1
Course Code: ELM-707
Duration: 45 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning Objectives
Who Should Take This Course?
Course Modules
Regulatory Expectations
The Regulations
The Benefits – Part 1
The Benefits – Part 2
Common Uses of Isolators
Sterility Isolators
Interface Isolators
Transfer Isolators
Filling Machine Isolators
Other Common Isolator Examples
Glove Ports & Half Suits
Reach Inside Isolator
Transfer Systems
Airlocks
Electrical Items
RTP Systems (Double Door Transfers)
Frequent Inspection
FDA & EC Guidance
Risk of Glove Damage
Glove Test Device
Transfer Risks
Microbial Contamination
Understanding the Concept
Pre-Conditioning
Bio-Decontamination
Post-Conditioning

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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