How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns

Every minute of every day, modern cleanrooms used for the manufacture of medical devices, pharmaceuticals, or combination products face widespread, persistent threats of contamination. Much of this contamination comes from the people working in these environments. They carry invasive organisms on their hands, feet, and clothes. They also bring contaminated equipment and materials into the environment. Risks of contamination also may increase with the seasons. For example, molds are prevalent during spring blooms or summer flowerings.

Other threats may exist in the cleanroom environments themselves. Water sources and drains are ready sources of foreign organisms, often due to broken, improperly installed, or clogged filtration devices. Heating, ventilation, and air conditioning systems may suffer similar problems with airborne contaminants. A HEPA filter charged with protecting against contaminants, when malfunctioning or filled to capacity may instead do the opposite. Any cleanroom surface may contain a sporeforming organism allowed to grow due to improper disinfectant selection or procedures.

As the U.S. Food and Drug Administration (FDA) states, “Characterization of recovered microorganisms provides vital information for the environmental monitoring program. Environmental isolates often correlate with the contaminants found in a media fill or product sterility testing failure and the overall environmental picture provides valuable information for an investigation. Monitoring critical and immediately surrounding clean areas as well as personnel should include routine identification of microorganisms to the species (or, where appropriate, genus) level.”1

However, identifying the culprits is a challenging task indeed. Cumulatively, thousands of organisms pose plausible threats, including the following:

• Gram-positive bacteria—numerous different species, including many that produce hard to kill spores
• Gram-negative bacteria—including numerous pseudomonases
• Molds—often during seasonal peaks
• Yeast