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Overview

Environmental monitoring (EM) testing is widely used to maintain overall facility cleanliness. Due to the fast spread of mold, being able to detect its presence fast is critical. Currently pharma manufacturers are limited by the length of the EM testing to detect mold presence. Using automation, the presence of mold can be detected in as early as 1 day. The expedited detection enables for a quicker remediation, if needed, using a validated cleaning procedure to return the facility to a decontaminated state. Further, automated detection enhances the data integrity of EM testing by removing the reliance on operator assessment to flag the presence of mold. 

Mold detection was tested at different temperatures and with various mold types, both of which are representative of typical EM testing. The data suggests a strong ability to detect various commonly found molds at traditional EM incubation temperatures.  

Objectives

• Outline current and proposed workflows associated with mold detection in EM testing
• Show incremental value around faster detection enabling faster remediation along with enhanced data integrity
• Report on specific mold species tested at a range of temperatures and the detection performance