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Aseptic Manufacturing Facilities

Introduction

Meet your trainer (2:04)
Course overview
Introduction and basic concepts (9:52)
HVAC (6:37)
Airlock (5:20)
Isolator (4:05)
RABS (7:33)
Isolator vs. RABS (4:18)
Quiz

Regulatory background

Introduction (1:57)
EU regulations (43:10)
Eudralex Volume 4 annex 1
Correct answers quiz annex 1
US regulations (19:57)
PIC/S, ISO14644 and regulations recap
Quiz 1
Quiz 2

Contamination control

What is contamination? (7:32)
Contamination control (7:29)

Cleanrooms and facility design

Introduction (6:22)
Facility design (21:53)
Material and personnel flows (6:32)
Changing rooms and airlocks (7:50)
Architectural detailing (4:23)
HVAC design (7:17)
Airflows (3:48)
Pressure differentials (5:13)
Air changes (3:58)

Cleanroom qualification

Introduction
Requirements of new Eudralex Volume 4 annex 1
Cleanroom finishes
Functional HVAC test
Filter leakage testing
Air pressure differentials
Airborne particle counts (12:43)
Quiz
Recovery test
Airflow velocity and uniformity
Airflow pattern visualization (smoke test)
Containment leak test
EMS
Microbial limits
Recap (3:56)

Operational controls

Cleaning and disinfection
Monitoring
Training
Maintenance
Requalification

Barrier technology

Introduction (5:54)
Types of isolators (5:10)
Types of RABS (1:40)
Design considerations (6:37)
Disinfection and transfer technologies (7:39)
Validation (4:37)

References and further reading

References

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