In spite of the cost of 13,000 man-hours per year to manually monitor cleanroom particle counting data, the use of particle counting software has not been widely adopted. When particle counting software is considered for cleanroom use, the software becomes an additional product that injects a new set of risks and imposes substantial change to established, approved, and validated cleanroom management processes. Some change-adverse cleanroom operations choose to follow the eight steps of manual data management rather than incur the risk and change their manufacturing processes. Furthermore, given limited manufacturing capacity, production uptime is critical to profitability for pharmaceutical production; changes can take weeks or months to complete.
A new portable particle counter, the MET ONE 3400 (Hach Co.), features internal software that creates an electronic PDF and a separate Microsoft Excel spreadsheet record written directly to a USB memory stick plugged into the particle counter. The system eliminates the need for printing on thermal paper, attaching to larger A4 paper, and data entry into a spreadsheet.
Particle counter operators can take samples throughout the cleanroom and return to their offices with the data in the secure electronic PDF format desired on a USB memory stick. In most cases, the environmental monitoring manager or quality control department will only require minimal change to SOPs, or the changes will be minimal and easy to accomplish.