ABSTRACT

This Technical Briefing provides information about airflow visualisation utilised within cleanrooms.

Information includes details relating to techniques for airflow visualisation, the testing methods and conditions utilised for meaningful cleanroom airflow visualisations required as part of the cleanroom qualification activities….

KEYWORDS: Acceptance Criteria, Airflow Visualisation, Airflow Visualisation Techniques, Annex 1 EU GGMP 1, Aseptic Processing, BS EN ISO 14644-3: 2019, Clean Zones, Cleanroom Qualification, Cleanroom Testing Methods, Deep Cleaning, Environmental Monitoring, HVAC, ISO 14644-3, Particles, Recovery of Cleanroom After Testing, Separative Devices, Smoke Pattern Testing, Sparge Pipes, Sterile Drug Products, Test Equipment, Test Procedures, Testing and Re-testing Frequency, Testing Occupancy States, Unidirectional Airflow (UDAF) Environments, US FDA Guidance, US Food and Drug Administration.

More detailed information and explanation regarding high efficiency air filters, including in-situ leak testing failures, are included in the following Honeyman training courses;

1. Cleanrooms: Principles in Practice®
2. Aseptic Processing: Principles in Practice®
3. Microbial Risk Management During Cleanroom Operations®

Further related information can be found in the following associated briefs:

1. Airborne Particle Counting Using LSAPC – Technical Briefing (PDF)
2. Cleanroom Classification – Technical Briefing (PDF)
3. Cleanroom Testing – Technical Briefing (PDF)
4. High Efficiency Air Filters – Technical Briefing (PDF)
5. Cleanroom Airflow Visualisation – Technical Briefing (PDF)
6. Liquid and Gas Filtration – Technical Briefing (PDF)
7. Cleanroom Garment – Technical Briefing (PDF)