Streamlining Particle Count Data Management

 By Paul Yates

Pharmaceutical Cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent-cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt to remain both competitive and compliant with U.S. Food and Drug Administration (FDA) regulations. The one constant element of Cleanrooms is the FDA requirement for monitoring non-viable particle counts in clean-rooms to ensure that the manufacturing of injectable drugs is performed in a safe, sterile environment. As with all regulatory environments, a substantial portion of daily work must be dedicated to managing clean room data and completing the paperwork associated with clean room particulate contamination control. In this application note, we will highlight the challenges of manual management of clean room particle count data and offer guidance on a more efficient approach to overcome change control barriers.