Selection Requirements to Establish
Work through what you can. Anything still undecided is exactly what a conversation with our engineers is for.
01Classification and standard
- ISO 14644-1 class, or the GMP grade being worked to
- Whether classification is at rest, in operation, or both
- Room area and volume, which set the minimum number of sample points
- Particle sizes that must be reported for that class
- Recovery and pressure-cascade tests within scope
02Measurement and instruments
- Portable counter for periodic classification, or fixed sensors for continuous monitoring
- Sample flow rate — 28.3 l/min shortens the sample time a class demands
- Number of monitoring locations and the sampling schedule
- Isokinetic probes, manifolds or sequencing where used
- Additional parameters: temperature, humidity, differential pressure, airflow
03Data, alarms and validation
- Alarm thresholds and how alarms are escalated
- Record retention, audit trail and electronic signature requirements
- Interface to the building management or monitoring system
- Reports required for qualification (IQ, OQ, PQ)
- Calibration and requalification intervals