Qualification & Validation

Annual or six monthly qualification of cleanrooms / air movement devices is an absolute requirement for pharmaceutical, medical, and laboratory facilities. 

This work requires experienced professionals to perform critical checks of the equipment and verification of key operational parameters to ensure the continued compliance of the equipment / environment within operating limits.

Icon Engineering are certified to ISO 9001:2015 and our staff have a wealth of experience in Validation & Qualification including the following:

• HEPA Filter Integrity Testing

• Air Volume Measurement

• Air Change Rate Measurement

• Particle Counts

• Temperature and Humidity Verification

• Room Differential Pressure Measurement & Optimisation

• Airflow Visualisation

• Room Recovery Testing

• Filter Face Velocity Testing

• Compressed Gas Testing

• Qualification of:
  

  • Unidirectional Airflow Devices

  • Fume Cupboards to EN 14175

  • Microbiological Safety Cabinets to EN 12469

  • Downflow Booths

Specialist Testing

• Gas Analysis of Purified Air Systems / Nitrogen etc.

• Bio Burden

• Hydrocarbon Testing

• Moisture Testing

• Ki Discus- Bio-Safety Hood Qualification 

• Tracer Gas Testing – Fumehood Qualification 

• Testing can be carried out on ICON templates or Client Specific Procedures.

Testing can be carried out on ICON Engineering procedures or Client Specific Procedures.