Classification of airborne molecular contamination

Verifica della classe di contaminazione particellare
Verifica della classe di contaminazione particellare
Verifica della classe di contaminazione particellare


  • Cleanroom Verification / Monitoring
  • Clean Bench Verification
  • IAQ Investigation
  • Food Processing Investigation
  • Hospital Surgical Rooms
  • Filter Testing


  • Simultaneously measures and displays 3 particle sizes
  • Built-in flow sensor ensures highly accurate measurement
  • Stores up to 10,000 measurements

The classification target for of airborne molecular contamination of clean rooms and operating rooms.
The criteria for the classification of airborne molecular contamination is intended to check whether the work area contamination actually belongs to the class of particle contamination established in static conditions (“at rest”), and operating conditions prescribed by the EU GMP annex 1 (2008).

Method of verification of airborne molecular contamination:
The criteria of classification of airborne molecular contamination has to be executed after that the air speed and air volumes have been verified, the integrity of HEPA filters have been checked, and the cleaning procedures has been performed.
The particles count test must be performed as described in ISO 14644-1, 1999 and in the EU GMP Annex 1, 2008.
Test both at rest and operational conditions, as follows:

  1. At rest conditions (at-rest) without personnel and instruments in operation.
  2. In operating conditions (operational) at the presence of one or two operators that simulate the

activities that are normally carried out.

  1. Use of a calibrated measuring device, suitable for the counting of airborne particles (counter light


During the verification of airborne molecular contamination test, air samples must be taken at a height not exceeding 40 cm from normal work plane, but not less than 150 cm from the floor.
Program the particle counter according to the frequency and the sampling volume established by the rules, in particular:


 Measuring Particle Size 0.3um, 0.5um, 5.0um
 Flow Rate  0.1 cfm (2.83 l/min)
 Light Source Laser Diode
 Calibration PSL particles in air
 Counting Efficiency 50% at 0.3 um; 100% for particles > 0.45 um (ISO 21501-4)
 Zero Count Less than 1 count / 5 minutes (ISO 21501-4)
 Coincidental Loss Less than 5% at 2,000,000 particles/cf
 Sampling Time 1 sec – 99 min 59 sec (1 second increment)
 Sampling Frequency 1 – 99 or continuous
 Count Modes Single, Repeat, Continuous, Calculation, Remote and ISO mode
 Display LCD: 20 letters, 4 lines
 Interface RS232C or RS485
 Baud Rate 9600 bps
 Buffer Memory 10,000 sample records
Power AC Adapter 5VDC at 2.5A, 100 – 240VAC, 50 to 60 Hz
Battery 4 x AA Batteries
Operating Time 3 hrs with 1600mAh Batteries
 Vacuum Source Internal pump, flow controlled