Controlling fungal and bacterial spores in pharmaceutical, biotech and medical device operations

Controlling Fungal and Bacterial Spores in Pharmaceutical, Biotech and Medical Device Operations Fungal spores and bacterial spores can cause significant contamination challenges in cleanrooms due to their prevalence in the environment and inherent resistance to chemical inactivation. The fatalities and illnesses due to fungal and bacterial spores associated with the New England Compounding Center contamination incident in 2012 is a terrible reminder of what can happen when cleanliness standards are not met and effective control strategies are not in place.

Investigating the source of contamination often involves resources from numerous departments including Quality, Engineering, Manufacturing, and Maintenance. Eliminating the contamination can be costly and time consuming, sometimes causing work interruption and a significant outlay of money and resources. Expensive retrofitting of facilities or large surfaces such as flooring or walls may be required to eliminate the contamination.

Identifying the contamination source and addressing excursions quickly with effective remediation strategies is essential to prevent large-scale contamination which can lead to product recalls, regulatory issues, economic loss, patient safety concerns and irreversible damage to a company’s reputation.