Calibration

The microbial air samplers used in the cleanroom of pharma industries, according to the requests of regulatory authorities, should be calibrated at regular intervals (e.g.: every 6 or 12 months).

The calibration is performed in STATIM LAB, a metrological calibration laboratory (ISO/EIC 17025:2017 accredited by Perry Johnson Laboratory Accreditation, Inc.) in Milan in few working days (excluding shipping days).

Re-validation is also recommended if the air sampler was potentially damaged or the flow rate was compromised.

When the air sampler arrives in STATIM LAB laboratory for general assistance or for the annual calibration, the technicians always follow this protocol:

• Instrument decontamination
• Check for possible damages of the body
• Ultrasonic cleaning of the aspiration head
• Cleaning and control of the aspiration chamber
• Check of the battery performances
• Calibration and regulation of the air flow rate
• Updating of the firmware
• Replacement of damaged parts with original components
• Issue of a new calibration certificate ISO/EIC 17025:2017