Microrite - Model CRV-M1 -Tracer Particle Generator System
Microrite’s Tracer Particle Generator system provides a cloud of Tracer Particles that are sub-micron (less than 1 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).
A High Output Cleanroom Vaporizer which creates a sterile vapor with no combustion by products
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.
- FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004
- ISO 14644-3:2005 Test Methods: - B.7.3.2 Tracer injection method, Table C.19 Materials or particles used in tracer injection methods
- CETA Certification Guide for Sterile Compounding Facilities CAG-003-2006 -13 Revised May 20, 2015
For cleanroom applications, particles which are Neutrally Buoyant are influenced only by air currents within the cleanroom or area being tested. Gravity and the particle cloud temperature and pressure do not influence their behavior during the testing.
Microrite’s Tracer Particles have a Very Low Settling Velocity compared with Water CO2 or Nitrogen Based “Cleanroom Foggers”
Vapor Pressure
Water, CO2 or Nitrogen Based ”Cleanroom Foggers” produce a high vapor pressure particle cloud that evaporates rapidly under normal atmospheric conditions and condenses rapidly once the cloud reaches its saturation vapor pressure.
References
Why are other Cleanroom Foggers Unsuitable for Testing Medical Product Cleanrooms?
Per CETA Certification Guide for Sterile Compounding Facilities CAG-003-2006 -13 Revised May 20, 2015 Section 13.5:
- Water based fog generators such as CO2 and liquid nitrogen create a fog that is heavier than air and do not always provide for an accurate representation of the actual air patterns.
- The smoke source should be as close to neutrally buoyant as possible. For example, when generating the fog in an area with no detectable airflow, it should not “fall out” or “drop”.
- Fog streams that are heavier than air may not detect updrafts and turbulence that are detected with a generally neutral buoyant detection stream.
The Controlled Environment Testing Association (CETA) is specifically referenced in USP 797 Section 5: Certification and Re-certification:
Before a compounding area is used to compound either Category 1 or 2 CSPs, it must be certified using procedures in the current Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding Facilities or an equivalent guideline.
