An environmental sampling process that employs technology, ensures cleanroom efficiency and security.

Today’s industry standard for collecting and recording the environmental monitoring (EM) process is paper. This paper-based method, which, for the most part, has not varied much since its inception in the late 1970s, can be time consuming for everyone involved, from the technician to the supervisor, and additionally has the potential for multiple errors introduced inadvertently at any step. Consider the popular grade school game “telephone.” One person starts a story that is continually twisted as it transfers from person-to-person until the last individual receives it and shares a totally different story from what was originally told. This misunderstanding and twisting of facts is not exclusive to verbal transmission of stories, as this can also be initiated by people’s handwriting and is often seen in the healthcare as well as the microbiology industries. What a technician writes on the media container or test worksheet in the lab may be misinterpreted by the next person to handle the document or sample. This misinterpretation that occurs during EM data collection, especially when it is a paperbased process, leads to significant recording errors that require time-consuming, labor-intensive corrective action procedures subsequently increasing overtime and lowering productivity.

Realizing the advantages afforded by wireless technology, the microbiology industry is spurring a shift to put paper in the past. A significant investment is being made in information technology solutions to move from paper-based systems to automated-data collection, management, and reporting. Regulatory agencies are encouraging the use of computer- based systems. According to the Parenteral Drug Association (PDA), the recommended procedure to collect data is to utilize a computer-based system for the following reasons:

• “Based on the large number of samples tested by a given facility, a computer-based data tracking system is recommended.”¹
• “A manual data entry or image scanner system with advantages of speed and accuracy can be used to populate tables.”¹

With new regulations emerging and the significant costs associated with paper-based data collection and recordkeeping, there is increasing demand to improve the efficiency and accuracy of quality control (QC) operations. In reaction to this demand, manufacturers supporting EM testing are beginning to integrate new intuitive wireless technologies into their product portfolios, such as barcode labeling, wireless communications, and remote control operations, for easy integration with EM data-management systems. The following examines how these new applications are addressing recently introduced regulations and helping the industry take full advantage of its information technology investments by automating the EM process from start to finish.