Bacillus species are Gram-positive, endospore-forming, rod-shaped bacteria that are ubiquitous in the environment. Many species of Bacillus have been placed in other genera including Paenibacillus, Brevibacillus, Geobacillus, and Lysinibacillus.
The vast majority of these bacteria are nonpathogenic, environmental organisms found in soil, air, dust, and debris. These organisms typically dominate indoor air in occupied buildings, are abundant in dust and on surfaces, and are common components of the microflora of cleanrooms. They share the ability to form endospores, which are tough, protective structures formed during conditions of environmental stress. Endospores are highly resistant to ultraviolet light, heat, and chemical disinfectants.
Because of their spore-forming capability and ubiquitous nature, Bacillus and related genera pose a risk in pharmaceutical sterile compounding and manufacturing settings.
Bacillus species are the most common bacteria associated with microbiological contamination of pharmaceutical products. They can enter cleanrooms through inadequately filtered air, on clothing and shoes of personnel, and on incoming materials. Material packaging, especially cardboard, may contain spores of Bacillus and fungi. Standard germicidal agents, such as isopropyl alcohol, quaternary ammonium compounds, and phenolics are not effective against bacterial spores. Inadequate cleaning and disinfection protocols, particularly failing to use a sporicidal agent or using it improperly, have been linked to pharmaceutical product contamination.
Sporicidal agents should be used once weekly in place of a germicidal detergent for daily surface cleaning to help mitigate the risk of contamination with Bacillus and other spore-forming bacteria.
At U.S. Micro Solutions, our microbiology laboratory is a licensed, accredited source for thorough and accurate environmental testing, including USP 797, Legionella, indoor air quality, healthcare & medical device, water analysis, and identification of specific pathogens. Visit our Laboratory Services page to learn more.
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