The Basic Principles of Isolator Technology

Description:

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.

Curriculum for this course:
Introduction
Overview 45 secs
Learning Objectives 1 min 31 secs
Who Should Take This Course? 1 min 21 secs
Course Modules 1 min 10 secs
Module 1: Regulatory Expectations in Aseptic Processing
Regulatory Expectations 1 min 12 secs
The Regulations 1 min 02 secs
Module 2: Aseptic Processing Using Isolation Systems
The Benefits – Part 1 1 min 30 secs
The Benefits – Part 2 1 min 17 secs
Module 3: Examples of Isolator Systems
Common Uses of Isolators 1 min 10 secs
Sterility Isolators 58 secs
Interface Isolators 1 min 02 secs
Transfer Isolators 1 min 31 secs
Filling Machine Isolators 1 min 14 secs
Other Common Isolator Examples 1 min 11 secs
Module 4: Handling Inside Isolators
Glove Ports & Half Suits 1 min 15 secs
Reach Inside Isolator 1 min 09 secs
Transfer Systems 48 secs
Airlocks 50 secs
Electrical Items 1 min 01 secs
RTP Systems (Double Door Transfers) 1 min 03 secs
Module 5: Integrity of Gloves & Sleeves
Frequent Inspection 1 min 25 secs
FDA & EC Guidance 1 min 10 secs
Risk of Glove Damage 1 min 15 secs
Glove Test Device 1 min 24 secs
Module 6: Microbiological Contamination Risk
Transfer Risks 1 min 07 secs
Microbial Contamination 1 min 18 secs
Module 7: The Use of VHP Chambers
Understanding the Concept 1 min 19 secs
Pre-Conditioning 1 min 20 secs
Bio-Decontamination 1 min 36 secs
Post-Conditioning 1 min 45 secs
Conclusion
Final Assessment
Certification
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