Non - Viable Particle count Testing
- Airborne particulate cleanliness tests are carried out to confirm the level of non-viable airborne particulate within the area under test and compare with the acceptable concentration levels for the class or grade of the area.
- The number of sample locations and sample volume at each location is calculated and established. The Particle Counter instrument then counts and records the levels of particulate at each agreed sample location.
- The particle count levels recorded, along with any statistical analysis (where applicable), are detailed on the individual printouts contained within our reports. Results are expressed in counts per cubic foot and also as concentration per cubic metre. Statistical analysis is expressed in concentration per cubic metre.
- The considered particles size(s) for classification and statistical analysis are detailed in our reports.
- Details of the requirements and procedures used are specified in ISO 14644-1 (2015).
- For EU GMP Grade clean area requirements, the procedure specified in EN ISO 14644-1 (2015) will be used for calculating
- sample volumes and locations, using the nearest ISO whole number Classification as the class reference. However, EU GMP concentration limits will be the overriding acceptance criteria (where applicable).