THE PROBLEM

Compromised HEPA filters jeopardize patient safety by increasing the probability of a bad batch despite all other factors being ideal.

• HEPA filter integrity must be validated at least semi-annually to ensure the functionality.
• The Aerosol Challenge is a widely used and accepted method for this test. This method requires the operator or “Certifier” to introduce an aerosolized inert oil upstream of the filter media while counting the particles which pass through downstream of the media with a calibrated Photometer.
• In most cases, this process requires gaining access to the upstream airflow to the filter. This “breach” can result in a complete “terminal clean” due to contaminates entering the space.
• In the case of facilities, where crawl spaces have been provided to introduce the aerosol may require a second operator to introduce the aerosol, while the first operator scans the filter media.
• Until now, the “certifier” must use a theoretical calculation to determine the concentration of the aerosol in the air stream.
• The “calculation” fails to account for such variables as distance, condensation, impaction, and loss of aerosol due to imperfections in the ductwork.
• These conditions require time and effort for the performance of the test, as well as increased downtime in the production cycle of your sterile area.