MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is ISO 9001:2008 certified and complies with U.S. GMP and Quality System Regulations. Our experts understand your needs for quality testing and timely, accurate results.

Non-Viable Particulate Monitoring - ISO 14644, Fed Std-209E, USP <1116>
A calibrated laser particle counter is used to sample a defined volume of air. The particle counter can measure a variety of particle sizes, most commonly 0.5 and 5.0 micron particles. Particle counts are recorded as the number of particles per volume of air sampled. Results can be reported per cubic foot, per FDSTD 209E, or per cubic meter, per ISO 14644. Note that FDSTD 209E has been retired and ISO 14644 is the current guidance that should be followed when developing a new Cleanroom environment. Regardless many companies still use FDSTD 209E.