Pharmaceutical Isolators

Test Procedures

• General checks will be made on the condition of any pre-filters within the workstation. The functions of the workstation will be checked for correct operation.
• Airflow readings are taken to calculate air change rates, measurements taken with a vane/hot wire anemometer, in accordance with BS EN ISO 14644-3 (2005).
• Pressure differentials are recorded using a calibrated micromanometer in accordance with BS EN ISO 14644-3 (2005).
• Filter integrity leak tests will be carried out on all HEPA filters in accordance with BS EN ISO 14644-3 (2005).
• Airborne particulate cleanliness counts will be carried out in accordance with BS EN 14644-1 (1999), and EU GMP Annex 1 (February 2008).
• Breach velocity tests will be carried out in accordance with BS EN 14644-7 (1999).
• Pressure decay tests will be carried out in accordance with BS EN 14644-7 (1999) (optional test).