How can pharmaceutical cleanrooms ensure compliance between certification visits if they don’t have centralized airflow monitoring?
Some existing pharmaceutical cleanrooms were designed without centralized monitoring systems. For these facility managers, certification is their primary means of ensuring compliance. It would be ideal, however, to know when intervention may be necessary during daily operations. The big question is: how do you accomplish this without adding considerable cost or disrupting the facility?
In the absence of airflow monitoring, what makes the most sense is to monitor the differential pressure maintained between the controlled environments and surrounding space. When changes occur in differential pressure, it often means that there are filter blockages or FFU failures. This is enough information to investigate the source of a problem.
The simplest way to accomplish this is with stand-alone censors. You can mount them inside the cleanroom so that staff can manually check the values. They would have to determine if the changes are significant and keep a through record of the data.
A more sophisticated process uses wireless censors that transmit data to a central computer where it is analyzed and recorded. These kits can come with various sorts of alarms and notifications to alert you when changes need your attention.
If you’re constructing a new facility, your options become more intricate. Network-capable FFU units supply centralized monitoring and airflow control, and they can be programmed to adjust and optimize air exchange based on the data it receives. Facility managers have a lot of options with this kind of technology; prices fluctuate with the capabilities, of course.
Real-time monitoring will supplement compliance between certifier visits. Those with existing facilities do have non-invasive, cost-efficient options that work well. If it’s time for cleanroom certification, contact Gerbig Engineering Company. Our experts have thirty years of experience. We also do validation and construction: 888-628-0056; firstname.lastname@example.org