FDA, PIC/S, EMA, WHO require (1) In situ Air Pattern Analysis (Smoke Studies or Air Flow Visualization) expertly reviewed with written conclusions and preferably captured on video.
(2) International cleanroom standards, cGMP guidance and (3) cleanroom testing practices indicate “Neutrally Buoyant Tracer Particles” for Air Flow Visualization. Finally, the Tracer Particle Injection Method as defined in ISO 14644-3:2005 requires the particles remain visible long enough to capture the actual airflow patterns.
Microrite’s Tracer Particle Generator system provides a cloud of Tracer Particles that are sub-micron (<1.0 micrometer) in size and are Neutrally Buoyant. These long lasting, Neutrally Buoyant Tracer Particles are ideal for getting a visual representation of air flow patterns in cleanrooms, barrier systems and the interfaces between areas of different classifications (e.g., Grade A/ISO Class 5 and Grade B/ISO Class 7 areas).
(1) FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004
(2) ISO 14644-3:2005 Test Methods: - B.7.3.2 Tracer injection method, Table C.19 Materials or particles used in tracer injection methods
(3) CETA Certification Guide for Sterile Compounding Facilities CAG-003-2006 -13 Revised May 20, 2015
A High Output Cleanroom Vaporizer which creates a sterile vapor with no combustion by products